<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/NCT01714245</url>
  </required_header>
  <id_info>
    <org_study_id>CLN 003.6</org_study_id>
    <nct_id>NCT01714245</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients</brief_title>
  <acronym>CLeaN</acronym>
  <official_title>A Multicenter, Prospective Study to Evaluate CLn® BodyWash As An Adjunctive Therapy in Pediatric Subjects With Moderate to Severe, Staphylococcus Aureus Colonized Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TopMD Skin Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TopMD Skin Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser&#xD;
      formulated with surfactants and preserved with sodium hypochlorite, is effective at&#xD;
      decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or&#xD;
      eczema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Staphylococcus aureus colonization and potential infection represent a common clinical&#xD;
      finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the&#xD;
      disease. Atopic patients are commonly colonized with S. aureus on both lesional and&#xD;
      non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the&#xD;
      bacterial infection as well as reduce the overall severity of AD. More recently, measures to&#xD;
      reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic&#xD;
      Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.&#xD;
&#xD;
      Given the increasing incidence of recurrent skin infections caused by S. aureus, measures&#xD;
      such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an&#xD;
      effort to decrease infection rates and disease severity in patients with atopic dermatitis,&#xD;
      recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy&#xD;
      in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in&#xD;
      patients without active clinical infection as one review noted limited benefit while another&#xD;
      study showed that dilute bleach baths improved AD.&#xD;
&#xD;
      Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of&#xD;
      adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium&#xD;
      hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common&#xD;
      surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation,&#xD;
      and is further diluted when lathered onto the skin with water. This over the counter product&#xD;
      is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower,&#xD;
      lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a&#xD;
      convenient alternative to bleach baths.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Health of Skin EASI</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change from baseline in Eczema Area Severity Index (EASI) Score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Health of Skin IGA</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change from baseline in Investigator Global Assessment (IGA) Score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Health of Skin BSA</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change from baseline in Body Surface Area (BSA) Score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>6 weeks</time_frame>
    <description>Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased itching</measure>
    <time_frame>6 weeks</time_frame>
    <description>Visual Analog Scale will be reviewed for decrease in pruritus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of bacteria</measure>
    <time_frame>6 weeks</time_frame>
    <description>Bacterial cultures will be evaluated for decreased quantitative numbers.</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Eczema</condition>
  <condition>Atopic Dermatitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients with Atopic Dermatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6 months to 18 years&#xD;
&#xD;
          -  moderate to severe Atopic Dermatitis&#xD;
&#xD;
          -  positive staphylococcus aureus skin culture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active clinical infection&#xD;
&#xD;
          -  on antibiotics in the last 4 weeks&#xD;
&#xD;
          -  on immunosuppression drug in the last 4 weeks&#xD;
&#xD;
          -  using bleach bath in the last 2 weeks&#xD;
&#xD;
          -  able to maintain current regimen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adelaide A. Hebert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Medical School - Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University, Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical School - Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Majewski S, Bhattacharya T, Asztalos M, Bohaty B, Durham KC, West DP, Hebert AA, Paller AS. Sodium hypochlorite body wash in the management of Staphylococcus aureus-colonized moderate-to-severe atopic dermatitis in infants, children, and adolescents. Pediatr Dermatol. 2019 Jul;36(4):442-447. doi: 10.1111/pde.13842. Epub 2019 Apr 15.</citation>
    <PMID>30983053</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eczema</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Compromised Skin</keyword>
  <keyword>Inflamed Skin</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01714245
org study id: CLN 003.6
nct id: NCT01714245
lead sponsor: 
has dmc: No
The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser
      formulated with surfactants and preserved with sodium hypochlorite, is effective at
      decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or
      eczema.
Staphylococcus aureus colonization and potential infection represent a common clinical
      finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the
      disease. Atopic patients are commonly colonized with S. aureus on both lesional and
      non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the
      bacterial infection as well as reduce the overall severity of AD. More recently, measures to
      reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic
      Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.

      Given the increasing incidence of recurrent skin infections caused by S. aureus, measures
      such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an
      effort to decrease infection rates and disease severity in patients with atopic dermatitis,
      recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy
      in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in
      patients without active clinical infection as one review noted limited benefit while another
      study showed that dilute bleach baths improved AD.

      Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of
      adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium
      hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common
      surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation,
      and is further diluted when lathered onto the skin with water. This over the counter product
      is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower,
      lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a
      convenient alternative to bleach baths.
observational model: Case-Only
time perspective: Prospective
measure: Improvement in Health of Skin EASI
time frame: 6 weeks
description: Change from baseline in Eczema Area Severity Index (EASI) Score.
measure: Improvement in Health of Skin IGA
time frame: 6 weeks
description: Change from baseline in Investigator Global Assessment (IGA) Score.
measure: Improvement in Health of Skin BSA
time frame: 6 weeks
description: Change from baseline in Body Surface Area (BSA) Score.
measure: Patient satisfaction
time frame: 6 weeks
description: Quality of Life Questionnaires will be reviewed for a patient and family satisfaction.
measure: Decreased itching
time frame: 6 weeks
description: Visual Analog Scale will be reviewed for decrease in pruritus.
measure: Reduction of bacteria
time frame: 6 weeks
description: Bacterial cultures will be evaluated for decreased quantitative numbers.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: No
last name: Adelaide A. Hebert, MD
role: Principal Investigator
affiliation: University of Texas Medical School - Houston
facility: 
facility: 
country: United States
citation: Majewski S, Bhattacharya T, Asztalos M, Bohaty B, Durham KC, West DP, Hebert AA, Paller AS. Sodium hypochlorite body wash in the management of Staphylococcus aureus-colonized moderate-to-severe atopic dermatitis in infants, children, and adolescents. Pediatr Dermatol. 2019 Jul;36(4):442-447. doi: 10.1111/pde.13842. Epub 2019 Apr 15.
PMID: 30983053
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Undecided