<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/NCT01675232</url>
  </required_header>
  <id_info>
    <org_study_id>HIC-1206010366</org_study_id>
    <nct_id>NCT01675232</nct_id>
  </id_info>
  <brief_title>A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis</brief_title>
  <official_title>A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy of two different corticosteroid&#xD;
      ointment application regimens for the treatment of eczema (atopic dermatitis).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of corticosteroid ointment application regimens on serum cortisol</measure>
    <time_frame>2 weeks after application of topical corticosteroids</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects associated with each corticosteroid application regimen</measure>
    <time_frame>3 months</time_frame>
    <description>Characterize and quantify adverse effects associated with each corticosteroid application regimen.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Soak and smear</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry smear</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soak and smear</intervention_name>
    <description>Corticosteroid ointment applied to wet skin once a day and dry skin once a day.</description>
    <arm_group_label>Soak and smear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Smear</intervention_name>
    <description>Corticosteroid ointment applied to dry skin twice a day.</description>
    <arm_group_label>Dry smear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet the clinical criteria for the diagnosis of atopic dermatitis&#xD;
&#xD;
          -  Have disease over at least 5% of their total body surface area.&#xD;
&#xD;
          -  Less than 18 years of age.&#xD;
&#xD;
          -  Families able to comprehend written instructions in English and able to complete&#xD;
             questionnaires with assistance if needed.&#xD;
&#xD;
          -  Parents/guardians able to understand and willing to sign a parental permission form.&#xD;
&#xD;
          -  Children between the ages of 7-17 years willing to sign an age-appropriate assent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are allergic or intolerant of the topical medications employed in this&#xD;
             study.&#xD;
&#xD;
          -  Lack of follow-up after initial visit or regimen noncompliance.&#xD;
&#xD;
          -  Patients who do not have access to a bathtub.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Weeks</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard J Antaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Richard Antaya</investigator_full_name>
    <investigator_title>Professor of Dermatology and Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Atopic dermatitis</keyword>
  <keyword>Topical corticosteroid</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Eczema</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>
  <!-- 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/NCT01675232
org study id: HIC-1206010366
nct id: NCT01675232
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the efficacy of two different corticosteroid
      ointment application regimens for the treatment of eczema (atopic dermatitis).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
time frame: 2 weeks
measure: Effect of corticosteroid ointment application regimens on serum cortisol
time frame: 2 weeks after application of topical corticosteroids
measure: Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen
time frame: 3 months
measure: Adverse effects associated with each corticosteroid application regimen
time frame: 3 months
description: Characterize and quantify adverse effects associated with each corticosteroid application regimen.
arm group label: Soak and smear
arm group type: Active Comparator
description: Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day.
arm group label: Dry smear
arm group type: Active Comparator
description: Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.
intervention type: Other
intervention name: Soak and smear
description: Corticosteroid ointment applied to wet skin once a day and dry skin once a day.
arm group label: Soak and smear
intervention type: Other
intervention name: Dry Smear
description: Corticosteroid ointment applied to dry skin twice a day.
arm group label: Dry smear
criteria: 
gender: All
minimum age: 2 Weeks
maximum age: 18 Years
healthy volunteers: No
last name: Richard J Antaya, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Richard Antaya
investigator title: Professor of Dermatology and Pediatrics
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema