<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/NCT01688531</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.SPR.40183E</org_study_id>
    <nct_id>NCT01688531</nct_id>
    <nct_alias>NCT01718665</nct_alias>
  </id_info>
  <brief_title>A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients</brief_title>
  <official_title>A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exploratory, international, multi-centre, randomized, investigator blinded study in acne&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Description and documentation of acne lesions</measure>
    <time_frame>over 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment effect on acne lesions</measure>
    <time_frame>over 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>CD0271 0.1%/CD1579 2.5% gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Split-face design, one application a day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD0271 0.1%/CD1579 2.5% gel vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Split-face design, one application a day for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD0271 0.1%/CD1579 2.5% gel</intervention_name>
    <description>one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months</description>
    <arm_group_label>CD0271 0.1%/CD1579 2.5% gel vehicle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD0271 0.1%/CD1579 2.5% gel vehicle</intervention_name>
    <description>one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months</description>
    <arm_group_label>CD0271 0.1%/CD1579 2.5% gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged 18 to 35 years inclusive&#xD;
&#xD;
          -  Subjects with active, moderate acne&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)&#xD;
&#xD;
          -  The subject has a severity of acne that is not amenable to treatment with&#xD;
             CD0271-CD1579 (Screening)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galderma Investigational site</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational site</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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/NCT01688531
org study id: RD.03.SPR.40183E
nct id: NCT01688531
nct alias: NCT01718665
lead sponsor: 
has dmc: No
Exploratory, international, multi-centre, randomized, investigator blinded study in acne
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Description and documentation of acne lesions
time frame: over 6 months
measure: Treatment effect on acne lesions
time frame: over 6 months
arm group label: CD0271 0.1%/CD1579 2.5% gel
arm group type: Experimental
description: Split-face design, one application a day for 6 months
arm group label: CD0271 0.1%/CD1579 2.5% gel vehicle
arm group type: Placebo Comparator
description: Split-face design, one application a day for 6 months
intervention type: Drug
intervention name: CD0271 0.1%/CD1579 2.5% gel
description: one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
arm group label: CD0271 0.1%/CD1579 2.5% gel vehicle
intervention type: Drug
intervention name: CD0271 0.1%/CD1579 2.5% gel vehicle
description: one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
arm group label: CD0271 0.1%/CD1579 2.5% gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Canada
country: France
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris