<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/NCT02192632</url>
  </required_header>
  <id_info>
    <org_study_id>ADP-BPO</org_study_id>
    <secondary_id>1402-051-555</secondary_id>
    <nct_id>NCT02192632</nct_id>
  </id_info>
  <brief_title>Dermatologists' Educational Demonstration for Epiduo Application</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and tolerability of this combination&#xD;
      gel compared with BPO monotherapy in Korean patients, and test clinical practicability of&#xD;
      dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable&#xD;
      irritations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Percentile reduction of non-inflammatory &amp; inflammatory acne lesions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurement of decreases in both non-inflammatory &amp; inflammatory acne lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of local irriation effect counts (erythema, scaling, dryness, itching)</measure>
    <time_frame>12 week</time_frame>
    <description>Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Facial Acne</condition>
  <condition>Local Adverse Effects</condition>
  <arm_group>
    <arm_group_label>Epiduo- dermatologist's detailed instruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epiduo- drug insert only gruop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPO group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After randomly assigned to side of BPO application, patients apply BPO during 12 week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epiduo once daily with detailed instruction for how to apply it</intervention_name>
    <arm_group_label>Epiduo- dermatologist's detailed instruction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epiduo- once daily, simple instruction for application</intervention_name>
    <arm_group_label>Epiduo- drug insert only gruop</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BPO once daily</intervention_name>
    <arm_group_label>BPO group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6&#xD;
&#xD;
          -  age: 18-40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  mental illness&#xD;
&#xD;
          -  intake of oral isotretinoin within 6 months&#xD;
&#xD;
          -  application of the other oral or topical acne medications&#xD;
&#xD;
          -  chemical peeling or light based treatments within 6 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology, Seoul National University</name>
      <address>
        <city>Seoul</city>
        <state>Joungro</state>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>March 10, 2015</last_update_submitted>
  <last_update_submitted_qc>March 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Dae Hun Suh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adapalene, Benzoyl Peroxide Drug Combination</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/NCT02192632
org study id: ADP-BPO
secondary id: 1402-051-555
nct id: NCT02192632
lead sponsor: 
The purpose of this study is to evaluate the efficacy and tolerability of this combination
      gel compared with BPO monotherapy in Korean patients, and test clinical practicability of
      dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable
      irritations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Percentile reduction of non-inflammatory & inflammatory acne lesions
time frame: 12 weeks
description: Measurement of decreases in both non-inflammatory & inflammatory acne lesions
measure: Total number of local irriation effect counts (erythema, scaling, dryness, itching)
time frame: 12 week
description: Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)
arm group label: Epiduo- dermatologist's detailed instruction
arm group type: Experimental
description: After randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist
arm group label: Epiduo- drug insert only gruop
arm group type: Experimental
description: After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group
arm group label: BPO group
arm group type: Placebo Comparator
description: After randomly assigned to side of BPO application, patients apply BPO during 12 week
intervention type: Drug
intervention name: Epiduo once daily with detailed instruction for how to apply it
arm group label: Epiduo- dermatologist's detailed instruction
intervention type: Drug
intervention name: Epiduo- once daily, simple instruction for application
arm group label: Epiduo- drug insert only gruop
intervention type: Drug
intervention name: BPO once daily
arm group label: BPO group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Dae Hun Suh
investigator title: Professor
mesh term: Adapalene, Benzoyl Peroxide Drug Combination