<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/NCT02241174</url>
  </required_header>
  <id_info>
    <org_study_id>SodiumHypochloriteAD</org_study_id>
    <nct_id>NCT02241174</nct_id>
  </id_info>
  <brief_title>0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis</brief_title>
  <official_title>Efficacy of 0.005% Sodium Hypochlorite Final Rinse Solution on the Reduction of Staphylococcus Aureus Colonization in Atopic Dermatitis: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makati Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makati Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the safety and efficacy of diluted bleach bath solution as final&#xD;
      rinse on the reduction of Staphylococcus aureus colonization among children and adult&#xD;
      Filipinos with mild to moderate atopic dermatitis..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To determine the safety and efficacy of 0.005% sodium hypochlorite final rinse&#xD;
      solution on the reduction of Staphylococcus aureus colonization among children and adult&#xD;
      Filipinos with mild to moderate atopic dermatitis.&#xD;
&#xD;
      Design: Randomized, double blind, controlled clinical trial. Setting: Makati Medical Center,&#xD;
      Dermatology Outpatient Department Participants: Patients with mild to moderate atopic&#xD;
      dermatitis, seen at Makati Medical Center Dermatology Outpatient Department.&#xD;
&#xD;
      Sample size: 68 (34 treatment group, 34 placebo group) Intervention: Eligible patients will&#xD;
      be randomly allocated to two groups. The subjects will either be in the treatment group&#xD;
      (0.005% sodium hypochlorite) or in the placebo group (bath water). Subjects will use a liter&#xD;
      of 0.005% sodium hypochlorite as a final rinse solution during bathing for the treatment&#xD;
      group and a liter of bath water for the placebo group. This intervention will be done twice a&#xD;
      week for 12 weeks. Both patients and assessors will be blinded to the treatment assignments.&#xD;
&#xD;
      Assessment of Outcome: The outcomes will be assessed at weeks 4 and 12. Primary outcome&#xD;
      measure will use culture findings, physician's global assessment (PGA) of severity of disease&#xD;
      and eczema area and severity index (EASI) score. Secondary outcome measure will assess&#xD;
      adverse effects during follow-up at weeks 4 and 12.&#xD;
&#xD;
      Data Analysis: Kruskal-Wallis Test will be used to compare the significant difference in&#xD;
      scores between the two groups and Wilcoxon Signed Rank Test will be used to compare&#xD;
      significant difference of before and after scores within each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study materials have expired, no patients were enrolled&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Culture and sensitivity findings</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary outcome of interest is the reduction of S. aureus colonization in skin lesion and the clinical improvement at week 4 and week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eczema Assessment Severity Index (EASI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI) b. Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI)&#xD;
Body regions to be assessed:&#xD;
Head/Neck&#xD;
Upper extremities&#xD;
Trunk&#xD;
Lower extremities&#xD;
In each of the body areas, the following key signs will be assessed:&#xD;
Erythema (E)&#xD;
Induration (I)&#xD;
Excoriation (Ex)&#xD;
Lichenification (L)&#xD;
Scoring from the above features:&#xD;
0 - none&#xD;
1 - mild&#xD;
2 - moderate&#xD;
3 - severe&#xD;
Body Surface Area involvement score:&#xD;
0 = no eruption&#xD;
1 = &lt;10%&#xD;
2 = 10%-29%&#xD;
3 = 30% - 49%&#xD;
4 = 50% - 69%&#xD;
5 = 70% - 89%&#xD;
6 = 90% - 100%&#xD;
EASI Score Body region EASI Score Head/neck (E + I + Ex + L) x Area x 0.1 Upper extremities (E + I + Ex + L) x Area x 0.2 Trunk (E + I + Ex + L) x Area x 0.3 Lower extremities (E + I + Ex + L) x Area x 0.4 EASI Sum of above scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Global Assessment (PGA) Scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>Severity of disease at baseline&#xD;
Mild:&#xD;
Moderate:&#xD;
Severe:&#xD;
Rating scale for PGA of Clinical Response at the end of the treatment&#xD;
Rating % Improvement Week 4 Week 12&#xD;
Cleared 100%&#xD;
Excellent improvement 90-99%&#xD;
Marked improvement 75-89%&#xD;
Moderate improvement 50-74%&#xD;
Slight improvement 30-49% No appreciable improvement 0-29%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Effect</measure>
    <time_frame>12 weeks</time_frame>
    <description>An adverse effect is an adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility. The term 'adverse effect' applies to all interventions, while 'adverse drug reaction' (ADR) is used only with drugs. Both will be measured in the study. All subjects will be asked if they have experienced any untoward effects from the intervention. In the event that any adverse events and adverse effects will be noted, immediate medical attention will be given to the participant(s) and the expenses of which, will be shouldered by the investigators.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Sodium Hypochlorite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100ml distilled water will be used as a placebo and will be stored on amber bottles identical with the treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Hypochlorite</intervention_name>
    <description>The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water. This 100ml solution will be stored in an amber glass bottle at room temperature unexposed to light at a maximum of 23 months</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Sodium Hypochlorite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females more than 8 years old.&#xD;
&#xD;
          2. Subjects with clinical diagnosis of atopic dermatitis (based on Hannifin and Rajka&#xD;
             criteria).&#xD;
&#xD;
          3. Healthy subjects with no other skin disease.&#xD;
&#xD;
          4. Subjects without any prior topical or oral antibiotic two weeks prior to the&#xD;
             enrollment period. Those who had undergone course of topical and oral antibiotic are&#xD;
             given at least 2 weeks washout period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe Atopic dermatitis requiring hospitalization.&#xD;
&#xD;
          2. Hospitalized and debilitated patients.&#xD;
&#xD;
          3. Subjects with other serious skin disorder, pigmentation or extensive scarring in&#xD;
             affected areas.&#xD;
&#xD;
          4. Subjects who have a known history or clinically relevant allergy, in particular to&#xD;
             chlorine containing compounds.&#xD;
&#xD;
          5. Pregnant women and nursing mothers.&#xD;
&#xD;
          6. Subjects who are in a situation, which, in the opinion of the investigator, may&#xD;
             interfere with optimal participation in the study.&#xD;
&#xD;
          7. Subjects participating or having participated in a clinical trial within 1 month&#xD;
             before enrollment in the study.&#xD;
&#xD;
          8. Subjects who cannot communicate with the investigator (&gt;18 years old) or are&#xD;
             unaccompanied by parent or legal guardian (&lt;18 years old).&#xD;
&#xD;
          9. Subjects who are unable to follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Marie L. Sarrosa, MD, FPDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makati Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jamaine Melisse L Cruz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makati Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makati Medical Center</name>
      <address>
        <city>Makati</city>
        <state>NCR</state>
        <zip>1229</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makati Medical Center</investigator_affiliation>
    <investigator_full_name>Jamaine Cruz, MD</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Atopic Dermatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Hypochlorite</mesh_term>
    <mesh_term>Eusol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02241174
org study id: SodiumHypochloriteAD
nct id: NCT02241174
lead sponsor: 
has dmc: No
This study will determine the safety and efficacy of diluted bleach bath solution as final
      rinse on the reduction of Staphylococcus aureus colonization among children and adult
      Filipinos with mild to moderate atopic dermatitis..
Objective: To determine the safety and efficacy of 0.005% sodium hypochlorite final rinse
      solution on the reduction of Staphylococcus aureus colonization among children and adult
      Filipinos with mild to moderate atopic dermatitis.

      Design: Randomized, double blind, controlled clinical trial. Setting: Makati Medical Center,
      Dermatology Outpatient Department Participants: Patients with mild to moderate atopic
      dermatitis, seen at Makati Medical Center Dermatology Outpatient Department.

      Sample size: 68 (34 treatment group, 34 placebo group) Intervention: Eligible patients will
      be randomly allocated to two groups. The subjects will either be in the treatment group
      (0.005% sodium hypochlorite) or in the placebo group (bath water). Subjects will use a liter
      of 0.005% sodium hypochlorite as a final rinse solution during bathing for the treatment
      group and a liter of bath water for the placebo group. This intervention will be done twice a
      week for 12 weeks. Both patients and assessors will be blinded to the treatment assignments.

      Assessment of Outcome: The outcomes will be assessed at weeks 4 and 12. Primary outcome
      measure will use culture findings, physician's global assessment (PGA) of severity of disease
      and eczema area and severity index (EASI) score. Secondary outcome measure will assess
      adverse effects during follow-up at weeks 4 and 12.

      Data Analysis: Kruskal-Wallis Test will be used to compare the significant difference in
      scores between the two groups and Wilcoxon Signed Rank Test will be used to compare
      significant difference of before and after scores within each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Culture and sensitivity findings
time frame: 12 weeks
description: The primary outcome of interest is the reduction of S. aureus colonization in skin lesion and the clinical improvement at week 4 and week 12.
measure: Eczema Assessment Severity Index (EASI)
time frame: 12 weeks
description: Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI) b. Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI)
Body regions to be assessed:
Head/Neck
Upper extremities
Trunk
Lower extremities
In each of the body areas, the following key signs will be assessed:
Erythema (E)
Induration (I)
Excoriation (Ex)
Lichenification (L)
Scoring from the above features:
0 - none
1 - mild
2 - moderate
3 - severe
Body Surface Area involvement score:
0 = no eruption
1 = <10%
2 = 10%-29%
3 = 30% - 49%
4 = 50% - 69%
5 = 70% - 89%
6 = 90% - 100%
EASI Score Body region EASI Score Head/neck (E + I + Ex + L) x Area x 0.1 Upper extremities (E + I + Ex + L) x Area x 0.2 Trunk (E + I + Ex + L) x Area x 0.3 Lower extremities (E + I + Ex + L) x Area x 0.4 EASI Sum of above scores
measure: Physician Global Assessment (PGA) Scale
time frame: 12 weeks
description: Severity of disease at baseline
Mild:
Moderate:
Severe:
Rating scale for PGA of Clinical Response at the end of the treatment
Rating % Improvement Week 4 Week 12
Cleared 100%
Excellent improvement 90-99%
Marked improvement 75-89%
Moderate improvement 50-74%
Slight improvement 30-49% No appreciable improvement 0-29%
measure: Adverse Effect
time frame: 12 weeks
description: An adverse effect is an adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility. The term 'adverse effect' applies to all interventions, while 'adverse drug reaction' (ADR) is used only with drugs. Both will be measured in the study. All subjects will be asked if they have experienced any untoward effects from the intervention. In the event that any adverse events and adverse effects will be noted, immediate medical attention will be given to the participant(s) and the expenses of which, will be shouldered by the investigators.
arm group label: Sodium Hypochlorite
arm group type: Experimental
description: The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water.
arm group label: Placebo
arm group type: Placebo Comparator
description: 100ml distilled water will be used as a placebo and will be stored on amber bottles identical with the treatment group
intervention type: Drug
intervention name: Sodium Hypochlorite
description: The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water. This 100ml solution will be stored in an amber glass bottle at room temperature unexposed to light at a maximum of 23 months
arm group label: Placebo
arm group label: Sodium Hypochlorite
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Donna Marie L. Sarrosa, MD, FPDS
role: Principal Investigator
affiliation: Makati Medical Center
last name: Jamaine Melisse L Cruz, MD
role: Principal Investigator
affiliation: Makati Medical Center
facility: 
country: Philippines
responsible party type: Principal Investigator
investigator affiliation: Makati Medical Center
investigator full name: Jamaine Cruz, MD
investigator title: Dr.
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Sodium Hypochlorite
mesh term: Eusol