<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216526</url>
  </required_header>
  <id_info>
    <org_study_id>CRC-SP-A-15</org_study_id>
    <nct_id>NCT02216526</nct_id>
  </id_info>
  <brief_title>Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents</brief_title>
  <official_title>A Prevalence and Multi-center Randomized Parallel-group Pragmatic Trial to Compare the Effectiveness of Standardized Skin Care Regimens on Skin Health in Nursing Home Residents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PD Dr. Jan Kottner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Residents of institutional long-term care facilities are at high risk for developing skin and&#xD;
      tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis,&#xD;
      candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant&#xD;
      melanoma) but there are few epidemiological figures about the actual frequencies of these&#xD;
      conditions in nursing homes. Therefore, in the first part of this study we aim at measuring&#xD;
      key dermatological conditions and associated health and functional status, and the skin care&#xD;
      practice of aged nursing home residents (&quot;prevalence study&quot;).&#xD;
&#xD;
      Basic skin care interventions are believed to reduce skin dryness and to enhance skin health.&#xD;
      Thus, the second aim of this study is to investigate the effectiveness of two structured skin&#xD;
      care regimens compared to the routine standard skin care on skin health in nursing home&#xD;
      residents (&quot;intervention study&quot;).&#xD;
&#xD;
      The study will be conducted in a random sample of seven out of approximately 300&#xD;
      institutional long term care facilities of the federal state of Berlin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Overall Dry Skin Score (ODS)</measure>
    <time_frame>Baseline; Day 56+/-4</time_frame>
    <description>Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stratum Corneum Hydration (SCH)</measure>
    <time_frame>Baseline, Day 56 +/- 4</time_frame>
    <description>Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values &gt; 40 a.u. are often considered 'normal', whereas values &lt; 40 a.u. are regarded as typical for dry Skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal Water Loss (TEWL)</measure>
    <time_frame>Baseline, Day 56 +/- 4</time_frame>
    <description>Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Surface pH</measure>
    <time_frame>Baseline, Day 56 +/- 4</time_frame>
    <description>Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Pressure Ulcer at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Clinical assessment of the presence of a pressure ulcer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Sum Score at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. The validity and reliability of the questionnaire was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Pressure Ulcer at Day 28 +/-3</measure>
    <time_frame>Day 28 +/-3</time_frame>
    <description>Clinical assessment of the presence of pressure ulcer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Pressure Ulcer at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Clinical assessment of the presence of a pressure ulcer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Skin Tears at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Clinical assessment of the presence of skin tears according to the STAR Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Skin Tears at Day 28 +/-3</measure>
    <time_frame>Day 28 +/-3</time_frame>
    <description>Clinical assessment aof the presence of skin tears according to the STAR Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Skin Tears at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Clinical assessment aof the presence of skin tears according to the STAR Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3</measure>
    <time_frame>Day 28 +/-3</time_frame>
    <description>Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Sum Score at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. The validity and reliability of the questionnaire was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.&#xD;
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.&#xD;
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3</measure>
    <time_frame>Day 56 +/-3</time_frame>
    <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Xerosis Cutis</condition>
  <arm_group>
    <arm_group_label>Cetaphil® Restoraderm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Excipial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard skin care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual skin care routine of the nursing home resident</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cetaphil® Restoraderm</intervention_name>
    <arm_group_label>Cetaphil® Restoraderm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Excipial</intervention_name>
    <arm_group_label>Excipial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &quot;Prevalence study&quot;&#xD;
&#xD;
          -  Living in the nursing home at the time of data collection;&#xD;
&#xD;
          -  Being 65+ years;&#xD;
&#xD;
          -  Written informed consent (or by legal representative);&#xD;
&#xD;
        Additional inclusion criteria for the &quot;intervention study&quot;&#xD;
&#xD;
          -  Overall dry skin score (ODS) of 2 to 4 at the right and left leg;&#xD;
&#xD;
          -  Willingness and ability to fulfil the study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        &quot;Prevalence study&quot;&#xD;
&#xD;
          -  Residents at the end of life (dying persons).&#xD;
&#xD;
        Additional exclusion criteria for the &quot;intervention study&quot;&#xD;
&#xD;
          -  Any dermatological condition or skin affection, e.g. acute weeping, excoriated or&#xD;
             inflammatory dermatitis, or skin treatment which may interfere with the study&#xD;
             assessments at the discretion of the investigator;&#xD;
&#xD;
          -  Any unstable acute or chronic pathology or condition that may interfere with the study&#xD;
             conduct at the discretion of the investigator;&#xD;
&#xD;
          -  Any use of topical drugs on the investigational areas two weeks prior to inclusion;&#xD;
&#xD;
          -  Systemic application of corticosteroids, antihistamine or other anti-inflammatory&#xD;
             drugs;&#xD;
&#xD;
          -  Known allergy or intolerance to any ingredient of the study products, e.g. urea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrike Blume-Peytavi, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>April 27, 2017</results_first_submitted>
  <results_first_submitted_qc>April 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2018</results_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>PD Dr. Jan Kottner</investigator_full_name>
    <investigator_title>Scientific Director Clinical Research Center for Hair and Skin Science</investigator_title>
  </responsible_party>
  <keyword>Skin health</keyword>
  <keyword>Nursing</keyword>
  <keyword>Long-term care</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>completed, recruitment period: September 2014 to May 2015, nursing homes</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cetaphil® Restoraderm</title>
          <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
        </group>
        <group group_id="P2">
          <title>Excipial</title>
          <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
        </group>
        <group group_id="P3">
          <title>Standard Skin Care</title>
          <description>Usual skin care routine of the nursing home resident</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hospitalization</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cetaphil® Restoraderm</title>
          <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
        </group>
        <group group_id="B2">
          <title>Excipial</title>
          <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
        </group>
        <group group_id="B3">
          <title>Standard Skin Care</title>
          <description>Usual skin care routine of the nursing home resident</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="133"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="44"/>
                    <count group_id="B4" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="44"/>
                    <count group_id="B4" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="45"/>
                    <count group_id="B2" value="44"/>
                    <count group_id="B3" value="44"/>
                    <count group_id="B4" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Overall Dry Skin Score (ODS)</title>
        <description>Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.</description>
        <time_frame>Baseline; Day 56+/-4</time_frame>
        <population>At Day 56 +/- 3 data of two participants to calculate the Change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group III (Standard Skin care) 35/36 participants were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Overall Dry Skin Score (ODS)</title>
          <description>Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.</description>
          <population>At Day 56 +/- 3 data of two participants to calculate the Change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group III (Standard Skin care) 35/36 participants were analyzed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.9"/>
                    <measurement group_id="O2" value="-1.2" spread="1.1"/>
                    <measurement group_id="O3" value="-0.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stratum Corneum Hydration (SCH)</title>
        <description>Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values &gt; 40 a.u. are often considered 'normal', whereas values &lt; 40 a.u. are regarded as typical for dry Skin.</description>
        <time_frame>Baseline, Day 56 +/- 4</time_frame>
        <population>At Day 56 +/- 3 data of four participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 34/36 participants were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Stratum Corneum Hydration (SCH)</title>
          <description>Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values &gt; 40 a.u. are often considered 'normal', whereas values &lt; 40 a.u. are regarded as typical for dry Skin.</description>
          <population>At Day 56 +/- 3 data of four participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 34/36 participants were analyzed.</population>
          <units>arbitrary units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="8.9"/>
                    <measurement group_id="O2" value="1.6" spread="10.1"/>
                    <measurement group_id="O3" value="2.0" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transepidermal Water Loss (TEWL)</title>
        <description>Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.</description>
        <time_frame>Baseline, Day 56 +/- 4</time_frame>
        <population>At Day 56 +/- 3 data of twelve participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 36/40 participants were analyzed. In Group II (Excipial) 38/41 participants were analyzed. In Group III (Standard Skin care) 31/36 participants were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Transepidermal Water Loss (TEWL)</title>
          <description>Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.</description>
          <population>At Day 56 +/- 3 data of twelve participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 36/40 participants were analyzed. In Group II (Excipial) 38/41 participants were analyzed. In Group III (Standard Skin care) 31/36 participants were analyzed.</population>
          <units>g/m2/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="11.4"/>
                    <measurement group_id="O2" value="1.4" spread="12.3"/>
                    <measurement group_id="O3" value="3.4" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Surface pH</title>
        <description>Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.</description>
        <time_frame>Baseline, Day 56 +/- 4</time_frame>
        <population>At Day 56 +/- 3 data of six participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 32/36 participants were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Surface pH</title>
          <description>Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.</description>
          <population>At Day 56 +/- 3 data of six participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 32/36 participants were analyzed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.7"/>
                    <measurement group_id="O2" value="0.3" spread="0.8"/>
                    <measurement group_id="O3" value="0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.1"/>
                    <measurement group_id="O2" value="1.0" spread="0.0"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Pressure Ulcer at Baseline</title>
        <description>Clinical assessment of the presence of a pressure ulcer.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Pressure Ulcer at Baseline</title>
          <description>Clinical assessment of the presence of a pressure ulcer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline</title>
        <description>Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline</title>
          <description>Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="3.9"/>
                    <measurement group_id="O2" value="7.1" spread="2.9"/>
                    <measurement group_id="O3" value="6.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Sum Score at Baseline</title>
        <description>Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. The validity and reliability of the questionnaire was recently supported.</description>
        <time_frame>Baseline</time_frame>
        <population>Only residents being cognitively not impaired were able to answer the questionnaires (At baseline n = 32/133)</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Sum Score at Baseline</title>
          <description>Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. The validity and reliability of the questionnaire was recently supported.</description>
          <population>Only residents being cognitively not impaired were able to answer the questionnaires (At baseline n = 32/133)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.42" spread="4.69"/>
                    <measurement group_id="O2" value="18.33" spread="4.18"/>
                    <measurement group_id="O3" value="11.09" spread="7.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Pressure Ulcer at Day 28 +/-3</title>
        <description>Clinical assessment of the presence of pressure ulcer.</description>
        <time_frame>Day 28 +/-3</time_frame>
        <population>After 4 weeks of the study, in total n= 13 participants were loss to follow up.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pressure Ulcer at Day 28 +/-3</title>
          <description>Clinical assessment of the presence of pressure ulcer.</description>
          <population>After 4 weeks of the study, in total n= 13 participants were loss to follow up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Pressure Ulcer at Day 56 +/-3</title>
        <description>Clinical assessment of the presence of a pressure ulcer.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>At the end of the study, in total n = 16 participants were loss to follow up.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pressure Ulcer at Day 56 +/-3</title>
          <description>Clinical assessment of the presence of a pressure ulcer.</description>
          <population>At the end of the study, in total n = 16 participants were loss to follow up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Skin Tears at Baseline</title>
        <description>Clinical assessment of the presence of skin tears according to the STAR Classification</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Skin Tears at Baseline</title>
          <description>Clinical assessment of the presence of skin tears according to the STAR Classification</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Skin Tears at Day 28 +/-3</title>
        <description>Clinical assessment aof the presence of skin tears according to the STAR Classification</description>
        <time_frame>Day 28 +/-3</time_frame>
        <population>In total n = 13 participants were loss to follow up after 4 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Skin Tears at Day 28 +/-3</title>
          <description>Clinical assessment aof the presence of skin tears according to the STAR Classification</description>
          <population>In total n = 13 participants were loss to follow up after 4 weeks.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Skin Tears at Day 56 +/-3</title>
        <description>Clinical assessment aof the presence of skin tears according to the STAR Classification</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>In total n = 16 participants were loss to follow up after eight weeks (end of the study).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Skin Tears at Day 56 +/-3</title>
          <description>Clinical assessment aof the presence of skin tears according to the STAR Classification</description>
          <population>In total n = 16 participants were loss to follow up after eight weeks (end of the study).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3</title>
        <description>Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification</description>
        <time_frame>Day 28 +/-3</time_frame>
        <population>In total n = 13 participants were loss to follow up after 4 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3</title>
          <description>Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification</description>
          <population>In total n = 13 participants were loss to follow up after 4 weeks.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3</title>
        <description>Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>In total n = 16 participants were loss to follow up after eight weeks (end of the study).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3</title>
          <description>Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification</description>
          <population>In total n = 16 participants were loss to follow up after eight weeks (end of the study).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Sum Score at Day 56 +/-3</title>
        <description>Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. The validity and reliability of the questionnaire was recently supported.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only residents being cognitively not impaired were able to answer the questionnaires (in total n = 28/117 at the end of the study).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Sum Score at Day 56 +/-3</title>
          <description>Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of &lt; 13 is recommended. The validity and reliability of the questionnaire was recently supported.</description>
          <population>Only residents being cognitively not impaired were able to answer the questionnaires (in total n = 28/117 at the end of the study).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.55" spread="5.22"/>
                    <measurement group_id="O2" value="19.00" spread="5.76"/>
                    <measurement group_id="O3" value="14.00" spread="5.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Baseline</time_frame>
        <population>Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="3.7"/>
                    <measurement group_id="O2" value="7.2" spread="3.4"/>
                    <measurement group_id="O3" value="6.5" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Baseline</time_frame>
        <population>Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.6"/>
                    <measurement group_id="O2" value="8.4" spread="2.1"/>
                    <measurement group_id="O3" value="7.0" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Baseline</time_frame>
        <population>Only residents being not cognitively impaired were able to answer the questionnaires (in total 32/133 at baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents being not cognitively impaired were able to answer the questionnaires (in total 32/133 at baseline).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="3.9"/>
                    <measurement group_id="O2" value="8.4" spread="2.3"/>
                    <measurement group_id="O3" value="7.8" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Baseline</time_frame>
        <population>Only residents not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline)</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="2.9"/>
                    <measurement group_id="O2" value="7.5" spread="2.8"/>
                    <measurement group_id="O3" value="7.0" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="2.9"/>
                    <measurement group_id="O2" value="7.9" spread="2.2"/>
                    <measurement group_id="O3" value="7.4" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="2.9"/>
                    <measurement group_id="O2" value="7.1" spread="2.8"/>
                    <measurement group_id="O3" value="8.0" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="2.9"/>
                    <measurement group_id="O2" value="7.5" spread="2.1"/>
                    <measurement group_id="O3" value="7.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="3.4"/>
                    <measurement group_id="O2" value="9.3" spread="0.6"/>
                    <measurement group_id="O3" value="7.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3</title>
        <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3</title>
          <description>Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.</description>
          <population>Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="3.1"/>
                    <measurement group_id="O2" value="8.1" spread="2.3"/>
                    <measurement group_id="O3" value="7.7" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.7"/>
                    <measurement group_id="O2" value="2.0" spread="1.0"/>
                    <measurement group_id="O3" value="1.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the quastionnaires (in total n = 32/133 at baseline). One value in the Excipial Group is missing for this question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the quastionnaires (in total n = 32/133 at baseline). One value in the Excipial Group is missing for this question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.5"/>
                    <measurement group_id="O2" value="4.0" spread="0.0"/>
                    <measurement group_id="O3" value="3.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline</title>
        <description>Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.&#xD;
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline</title>
          <description>Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.&#xD;
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.6"/>
                    <measurement group_id="O2" value="1.2" spread="0.7"/>
                    <measurement group_id="O3" value="1.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline). One value in the Cetaphil Group is missing for this question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline). One value in the Cetaphil Group is missing for this question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.3"/>
                    <measurement group_id="O2" value="1.4" spread="0.7"/>
                    <measurement group_id="O3" value="1.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Excipial Group one value is missing for that question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Excipial Group one value is missing for that question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.0"/>
                    <measurement group_id="O2" value="1.1" spread="0.4"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.0"/>
                    <measurement group_id="O2" value="1.8" spread="0.7"/>
                    <measurement group_id="O3" value="1.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.8"/>
                    <measurement group_id="O2" value="2.9" spread="1.6"/>
                    <measurement group_id="O3" value="3.3" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3</title>
        <description>Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.&#xD;
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3</title>
          <description>Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.&#xD;
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                    <measurement group_id="O2" value="1.0" spread="0.0"/>
                    <measurement group_id="O3" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3</title>
        <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
        <time_frame>Day 56 +/-3</time_frame>
        <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Cetaphil Group one value is missing for that question.</population>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil® Restoraderm</title>
            <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
          </group>
          <group group_id="O2">
            <title>Excipial</title>
            <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
          </group>
          <group group_id="O3">
            <title>Standard Skin Care</title>
            <description>Usual skin care routine of the nursing home resident</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3</title>
          <description>Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.&#xD;
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores &gt; 8 were classified as 'cognitively impaired'.</description>
          <population>Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Cetaphil Group one value is missing for that question.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                    <measurement group_id="O2" value="1.1" spread="0.4"/>
                    <measurement group_id="O3" value="1.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Undesirable effects, defined as any adverse reaction clearly linked to the normal or reasonably foreseeable use of a cosmetic product, were monitored from the time informed consent was obtained until study completion, an average of 10 weeks. All subjects experiencing undesirable effects were monitored until symptoms subsided, or until there was a satisfactory explanation for the changes observed.</time_frame>
      <desc>The intensity of the undesirable effect was described in terms of mild, moderate or severe.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cetaphil® Restoraderm</title>
          <description>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks&#xD;
Cetaphil® Restoraderm</description>
        </group>
        <group group_id="E2">
          <title>Excipial</title>
          <description>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks&#xD;
Excipial</description>
        </group>
        <group group_id="E3">
          <title>Standard Skin Care</title>
          <description>Usual skin care routine of the nursing home resident</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itch and redness on arms</sub_title>
                <description>Intensity was mild, products were withdrawn</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Erythema face</sub_title>
                <description>Intensity was moderate, Dose was reduced, facial application was stopped</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Redness, irritation at the whole body</sub_title>
                <description>Intensity was severe, Products were withdrawn</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Skin dryness at the back</sub_title>
                <description>Intensity was mild, products were withdrawn</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Residents, care givers, and study personnal was not blinded. Skin measurements were not conducted under standardized conditions.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>PD Dr. Jan Kottner</name_or_title>
      <organization>Charité Universitätsmedizin Berlin, Germany</organization>
      <phone>+49 (0)30 450 518 218</phone>
      <email>jan.kottner@charite.de</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216526
org study id: CRC-SP-A-15
nct id: NCT02216526
lead sponsor: 
has dmc: No
Residents of institutional long-term care facilities are at high risk for developing skin and
      tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis,
      candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant
      melanoma) but there are few epidemiological figures about the actual frequencies of these
      conditions in nursing homes. Therefore, in the first part of this study we aim at measuring
      key dermatological conditions and associated health and functional status, and the skin care
      practice of aged nursing home residents ("prevalence study").

      Basic skin care interventions are believed to reduce skin dryness and to enhance skin health.
      Thus, the second aim of this study is to investigate the effectiveness of two structured skin
      care regimens compared to the routine standard skin care on skin health in nursing home
      residents ("intervention study").

      The study will be conducted in a random sample of seven out of approximately 300
      institutional long term care facilities of the federal state of Berlin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change From Baseline in Overall Dry Skin Score (ODS)
time frame: Baseline; Day 56+/-4
description: Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.
measure: Stratum Corneum Hydration (SCH)
time frame: Baseline, Day 56 +/- 4
description: Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values > 40 a.u. are often considered 'normal', whereas values < 40 a.u. are regarded as typical for dry Skin.
measure: Transepidermal Water Loss (TEWL)
time frame: Baseline, Day 56 +/- 4
description: Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.
measure: Skin Surface pH
time frame: Baseline, Day 56 +/- 4
description: Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.
measure: Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline
time frame: Baseline
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Number of Participants With a Pressure Ulcer at Baseline
time frame: Baseline
description: Clinical assessment of the presence of a pressure ulcer.
measure: Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline
time frame: Baseline
description: Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification
measure: Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline
time frame: Baseline
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Life Sum Score at Baseline
time frame: Baseline
description: Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.
measure: Number of Participants With Pressure Ulcer at Day 28 +/-3
time frame: Day 28 +/-3
description: Clinical assessment of the presence of pressure ulcer.
measure: Number of Participants With Pressure Ulcer at Day 56 +/-3
time frame: Day 56 +/-3
description: Clinical assessment of the presence of a pressure ulcer.
measure: Number of Participants With Skin Tears at Baseline
time frame: Baseline
description: Clinical assessment of the presence of skin tears according to the STAR Classification
measure: Number of Participants With Skin Tears at Day 28 +/-3
time frame: Day 28 +/-3
description: Clinical assessment aof the presence of skin tears according to the STAR Classification
measure: Number of Participants With Skin Tears at Day 56 +/-3
time frame: Day 56 +/-3
description: Clinical assessment aof the presence of skin tears according to the STAR Classification
measure: Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3
time frame: Day 28 +/-3
description: Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification
measure: Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3
time frame: Day 56 +/-3
description: Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification
measure: Quality of Life Sum Score at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.
measure: Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline
time frame: Baseline
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline
time frame: Baseline
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline
time frame: Baseline
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline
time frame: Baseline
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.
measure: Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline
time frame: Baseline
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline
time frame: Baseline
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline
time frame: Baseline
description: Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline
time frame: Baseline
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.
Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
measure: Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3
time frame: Day 56 +/-3
description: Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'.
arm group label: Cetaphil® Restoraderm
arm group type: Experimental
description: Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks
arm group label: Excipial
arm group type: Experimental
description: Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks
arm group label: Standard skin care
arm group type: No Intervention
description: Usual skin care routine of the nursing home resident
intervention type: Other
intervention name: Cetaphil® Restoraderm
arm group label: Cetaphil® Restoraderm
intervention type: Other
intervention name: Excipial
arm group label: Excipial
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ulrike Blume-Peytavi, Prof. Dr.
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: PD Dr. Jan Kottner
investigator title: Scientific Director Clinical Research Center for Hair and Skin Science
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Residents, care givers, and study personnal was not blinded. Skin measurements were not conducted under standardized conditions.
point of contact: 