<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/NCT01724229</url>
  </required_header>
  <id_info>
    <org_study_id>COV2012</org_study_id>
    <nct_id>NCT01724229</nct_id>
  </id_info>
  <brief_title>Clinical Case Series Evaluating Skin Wellness System</brief_title>
  <official_title>An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GM Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GM Associates</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this evaluation is to observe the performance of two (2) different skin care&#xD;
      treatment protocols on the skin:&#xD;
&#xD;
      #1 Kendall™ Body Wash &amp; Shampoo in combination with the Moisture Barrier Cream; or #2&#xD;
      Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.&#xD;
&#xD;
      The scientific evidence supports using these types of skin care products to keep the skin&#xD;
      healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are&#xD;
      preferred over soap and water and can be applied on all areas of the skin. The Moisture&#xD;
      Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The&#xD;
      Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch,&#xD;
      and ring worm to relieve itching, soreness, and irritation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Kendall™ Body Wash &amp; Shampoo is a no-rinse cleanser that gently removed dirt, urine, and&#xD;
      stool while maintaining the natural pH of the skin (although it contains a shampoo&#xD;
      component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream&#xD;
      performs as a barrier to moisture and irritants when the natural barrier ability of the skin&#xD;
      has been compromised.&#xD;
&#xD;
      Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool&#xD;
      and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to&#xD;
      relieve itching and discomfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>skin condition following treatment</measure>
    <time_frame>14 days</time_frame>
    <description>Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Moisture-associated Dermatitis</condition>
  <condition>Fungal Infection in Perineal Area</condition>
  <arm_group>
    <arm_group_label>treatment with OTC drug products</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Body Wash &amp; Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary.&#xD;
Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor.&#xD;
2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary.&#xD;
Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kendall Body Wash &amp; Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream</intervention_name>
    <arm_group_label>treatment with OTC drug products</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult subjects with any of the following indications:&#xD;
&#xD;
          -  Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal&#xD;
             incontinence&#xD;
&#xD;
          -  Irritated, unbroken skin (perineal area)&#xD;
&#xD;
          -  Fungal infection present in the perineal area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An existing pressure ulcer of any stage where the product will be applied&#xD;
&#xD;
          -  Subjects not expected to survive the two week trial&#xD;
&#xD;
          -  Subjects under age 18&#xD;
&#xD;
          -  Subjects unable to provide informed consent (or whose designated power of attorney is&#xD;
             unable to provide)&#xD;
&#xD;
          -  Subjects with known sensitivity to any product preservative or other ingredient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenda J Motta, BSN, MPH, ET</last_name>
    <role>Study Director</role>
    <affiliation>GM Associates Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Villa Maria Care Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deer Meadows Retirement Community</name>
      <address>
        <city>Southampton</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.</citation>
    <PMID>22193141</PMID>
  </reference>
  <reference>
    <citation>Kennedy K, Leighton B, Lutz J. Cost-effectiveness evaluation of a new alchool-free, film-forming incontinence skin protectant. proceedings from the European Conference on Advances in Wound Management, Amsterdam, Oct. 1996</citation>
  </reference>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>June 24, 2013</last_update_submitted>
  <last_update_submitted_qc>June 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incontinence-associated dermatitis</keyword>
  <keyword>Skin care regimen for moisture-associated conditions</keyword>
  <keyword>Perineal skin care</keyword>
  <keyword>Fungal infection in perineal area</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antifungal Agents</mesh_term>
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 9, 2016</submitted>
    <returned>October 3, 2016</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01724229
org study id: COV2012
nct id: NCT01724229
lead sponsor: 
has dmc: Yes
The purpose of this evaluation is to observe the performance of two (2) different skin care
      treatment protocols on the skin:

      #1 Kendall™ Body Wash & Shampoo in combination with the Moisture Barrier Cream; or #2
      Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.

      The scientific evidence supports using these types of skin care products to keep the skin
      healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are
      preferred over soap and water and can be applied on all areas of the skin. The Moisture
      Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The
      Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch,
      and ring worm to relieve itching, soreness, and irritation.
The Kendall™ Body Wash & Shampoo is a no-rinse cleanser that gently removed dirt, urine, and
      stool while maintaining the natural pH of the skin (although it contains a shampoo
      component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream
      performs as a barrier to moisture and irritants when the natural barrier ability of the skin
      has been compromised.

      Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool
      and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to
      relieve itching and discomfort.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: skin condition following treatment
time frame: 14 days
description: Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition
arm group label: treatment with OTC drug products
arm group type: Other
description: Body Wash & Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary.
Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor.
2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary.
Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor.
intervention type: Drug
intervention name: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream
arm group label: treatment with OTC drug products
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Glenda J Motta, BSN, MPH, ET
role: Study Director
affiliation: GM Associates Inc.
facility: 
facility: 
country: United States
citation: Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
PMID: 22193141
citation: Kennedy K, Leighton B, Lutz J. Cost-effectiveness evaluation of a new alchool-free, film-forming incontinence skin protectant. proceedings from the European Conference on Advances in Wound Management, Amsterdam, Oct. 1996
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Dermatitis
mesh term: Antifungal Agents
mesh term: Clotrimazole
mesh term: Miconazole
submitted: August 9, 2016
returned: October 3, 2016