<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/NCT03034460</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.SPR.109807</org_study_id>
    <nct_id>NCT03034460</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of CD5024 1% in Acne Vulgaris</brief_title>
  <official_title>Efficacy and Safety of CD5024 1% in Acne Vulgaris</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, multi-center, randomised, investigator-blinded, vehicle controlled study using&#xD;
      intra-individual comparison involving subjects with acne vulgaris on face to evaluate the&#xD;
      efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study drugs application will be performed once daily, 5 days a week during 6 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2016</start_date>
  <completion_date type="Actual">November 2, 2016</completion_date>
  <primary_completion_date type="Actual">November 2, 2016</primary_completion_date>
  <phase>Phase 2</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammatory Lesion Count (Papules and Pustules) at Day 40</measure>
    <time_frame>Day 40</time_frame>
    <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)</measure>
    <time_frame>Baseline (Day 1)</time_frame>
    <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40</measure>
    <time_frame>Baseline (Day 1), and Day 40</time_frame>
    <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Lesion Count at Baseline (Day 1) and Day 40</measure>
    <time_frame>Baseline (Day 1), and Day 40</time_frame>
    <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40</measure>
    <time_frame>Baseline (Day 1), and Day 40</time_frame>
    <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40</measure>
    <time_frame>Baseline (Day 1), and Day 40</time_frame>
    <description>Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40</measure>
    <time_frame>Baseline (Day 1), and Day 40</time_frame>
    <description>Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40</measure>
    <time_frame>Day 40</time_frame>
    <description>The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40</measure>
    <time_frame>Day 40</time_frame>
    <description>The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From start of study up to follow up (Week 7)</time_frame>
    <description>AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)</measure>
    <time_frame>From Day 1 up Follow up (Week 7)</time_frame>
    <description>Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>CD5024 1% cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active drug;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD5024 cream placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo of active drug;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD0271/CD1579 gel</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Positive control;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD0271/CD1579 gel placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Placebo of positive control;</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD5024 1% cream</intervention_name>
    <description>500 µL on half-face, five days a week during 6 weeks</description>
    <arm_group_label>CD5024 1% cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD5024 cream placebo</intervention_name>
    <description>500 µL on half-face, five days a week during 6 weeks</description>
    <arm_group_label>CD5024 cream placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD0271/CD1579 gel</intervention_name>
    <description>500 µL on half-face, five days a week during 6 weeks</description>
    <arm_group_label>CD0271/CD1579 gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD0271/CD1579 gel placebo</intervention_name>
    <description>500 µL on half-face, five days a week during 6 weeks</description>
    <arm_group_label>CD0271/CD1579 gel placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is a male or a female aged from 18 to 35 years old at screening visit.&#xD;
&#xD;
          2. The subject has a medical diagnosis of acne vulgaris :&#xD;
&#xD;
             2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred)&#xD;
             non-inflammatory lesions (nose is excluded for the lesion count) at Baseline&#xD;
&#xD;
             2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as&#xD;
             compared to the other side at Baseline&#xD;
&#xD;
          3. If the subject is a female of childbearing potential, she must agree to use an&#xD;
             effective contraceptive method for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject has an underlying known disease surgical or medical condition, in the&#xD;
             opinion of the investigator might interfere with interpretation of the study results&#xD;
             or put the subject at risk (e.g., other dermatological diseases affecting the&#xD;
             treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or&#xD;
             serious diseases which would normally prevent participation in any clinical study,&#xD;
             such as a cancer, leukemia or severe hepatic impairment), (Screening).&#xD;
&#xD;
          2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne,&#xD;
             drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.&#xD;
&#xD;
          3. The subject has a known or suspected allergies or sensitivities to any components of&#xD;
             any of the study drugs (see Investigator's Brochure/Product label).&#xD;
&#xD;
          4. The subject is a male with beard or facial hair, which would interfere with clinical&#xD;
             evaluation or clinical procedure (Screening and Baseline).&#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 (# 8060)</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 5L7</zip>
        <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>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma investigational site</name>
      <address>
        <city>Munster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>November 16, 2020</results_first_submitted>
  <results_first_submitted_qc>November 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 11, 2020</results_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2020</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at six centers in three countries (Germany, France, Canada) between 25 April 2016 (first participant screened) to 02 November 2016 (last participant completed).</recruitment_details>
      <pre_assignment_details>A total of 70 participants were randomized, of which 64 participants completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group I: CD5024 Cream Versus Its Vehicle</title>
          <description>Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
        </group>
        <group group_id="P2">
          <title>Group II: Epiduo Gel Versus Its Vehicle</title>
          <description>Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group I: CD5024 Cream Versus Its Vehicle</title>
          <description>Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
        </group>
        <group group_id="B2">
          <title>Group II: Epiduo Gel Versus Its Vehicle</title>
          <description>Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="48"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.3" spread="4.7"/>
                    <measurement group_id="B2" value="23.4" spread="4.4"/>
                    <measurement group_id="B3" value="23.3" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of inflammatory lesions</title>
          <units>Lesion Count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.0" spread="11.6"/>
                    <measurement group_id="B2" value="34.2" spread="15.1"/>
                    <measurement group_id="B3" value="34.0" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Inflammatory Lesion Count (Papules and Pustules) at Day 40</title>
        <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
        <time_frame>Day 40</time_frame>
        <population>This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all participants who were randomized. Outcome measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Inflammatory Lesion Count (Papules and Pustules) at Day 40</title>
          <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
          <population>This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all participants who were randomized. Outcome measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="5.8"/>
                    <measurement group_id="O2" value="8.9" spread="5.0"/>
                    <measurement group_id="O3" value="6.1" spread="4.9"/>
                    <measurement group_id="O4" value="9.4" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream [n=48] versus CD5024 1% Cream Matched Placebo [n=48]).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.158</p_value>
            <method>Wilcoxon rank signed test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde [n=22] versus Adapalene Benzoyl Peroxyde Matched Placebo [n=22]).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.002</p_value>
            <method>Wilcoxon rank signed test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)</title>
        <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
        <time_frame>Baseline (Day 1)</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all partcipants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)</title>
          <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
          <population>This analysis was performed on ITT population. ITT population included all partcipants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" spread="4.9"/>
                    <measurement group_id="O2" value="17.5" spread="7.4"/>
                    <measurement group_id="O3" value="17.6" spread="8.6"/>
                    <measurement group_id="O4" value="16.6" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40</title>
        <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
        <time_frame>Baseline (Day 1), and Day 40</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40</title>
          <description>Inflammatory lesion count corresponded to the sum of papules and pustules.</description>
          <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>percent reduction of lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7" spread="43.4"/>
                    <measurement group_id="O2" value="44.4" spread="32.3"/>
                    <measurement group_id="O3" value="65.5" spread="24.0"/>
                    <measurement group_id="O4" value="42.5" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Lesion Count at Baseline (Day 1) and Day 40</title>
        <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.</description>
        <time_frame>Baseline (Day 1), and Day 40</time_frame>
        <population>This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT population included all participants who were randomized. Outcome Measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Lesion Count at Baseline (Day 1) and Day 40</title>
          <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.</description>
          <population>This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT population included all participants who were randomized. Outcome Measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7" spread="11.2"/>
                    <measurement group_id="O2" value="39.4" spread="13.7"/>
                    <measurement group_id="O3" value="37.3" spread="20.2"/>
                    <measurement group_id="O4" value="36.4" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="16.8"/>
                    <measurement group_id="O2" value="25.9" spread="14.3"/>
                    <measurement group_id="O3" value="19.3" spread="15.0"/>
                    <measurement group_id="O4" value="25.5" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40</title>
        <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.</description>
        <time_frame>Baseline (Day 1), and Day 40</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40</title>
          <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.</description>
          <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>percent reduction in total lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="32.2"/>
                    <measurement group_id="O2" value="34.0" spread="27.1"/>
                    <measurement group_id="O3" value="50.2" spread="27.2"/>
                    <measurement group_id="O4" value="27.8" spread="31.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40</title>
        <description>Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.</description>
        <time_frame>Baseline (Day 1), and Day 40</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40</title>
          <description>Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.</description>
          <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" spread="9.5"/>
                    <measurement group_id="O2" value="21.8" spread="10.7"/>
                    <measurement group_id="O3" value="19.6" spread="14.1"/>
                    <measurement group_id="O4" value="19.6" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" spread="13.1"/>
                    <measurement group_id="O2" value="16.9" spread="12.7"/>
                    <measurement group_id="O3" value="13.0" spread="12.0"/>
                    <measurement group_id="O4" value="16.0" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40</title>
        <description>Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.</description>
        <time_frame>Baseline (Day 1), and Day 40</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40</title>
          <description>Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.</description>
          <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>percent reduction of lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>One side of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>One side of face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" spread="39.4"/>
                    <measurement group_id="O2" value="21.3" spread="42.0"/>
                    <measurement group_id="O3" value="36.9" spread="36.1"/>
                    <measurement group_id="O4" value="11.7" spread="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40</title>
        <description>The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.</description>
        <time_frame>Day 40</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I: CD5024 Cream Versus Its Vehicle</title>
            <description>Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
          </group>
          <group group_id="O2">
            <title>Group II: Epiduo Gel Versus Its Vehicle</title>
            <description>Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40</title>
          <description>The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.</description>
          <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 40 (Active much better than Vehicle)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (Active better than Vehicle)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (No clinical difference between Active and Vehicle)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (Vehicle better than Active)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (Vehicle much better than Active)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40</title>
        <description>The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.</description>
        <time_frame>Day 40</time_frame>
        <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I: CD5024 Cream Versus Its Vehicle</title>
            <description>Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
          </group>
          <group group_id="O2">
            <title>Group II: Epiduo Gel Versus Its Vehicle</title>
            <description>Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40</title>
          <description>The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.</description>
          <population>This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 40 (Active much better than Vehicle)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (Active better than Vehicle)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (No clinical difference between Active and Vehicle)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (Vehicle better than Active)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 40 (Vehicle much better than Active)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
        <time_frame>From start of study up to follow up (Week 7)</time_frame>
        <population>This analysis was performed on safety population. Safety population included participants in the ITT population who received at least 1 application of the investigational product. Number of participants with AE's were reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Group I: CD5024 Cream Versus Its Vehicle</title>
            <description>Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
          </group>
          <group group_id="O2">
            <title>Group II: Epiduo Gel Versus Its Vehicle</title>
            <description>Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
          <population>This analysis was performed on safety population. Safety population included participants in the ITT population who received at least 1 application of the investigational product. Number of participants with AE's were reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)</title>
        <description>Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.</description>
        <time_frame>From Day 1 up Follow up (Week 7)</time_frame>
        <population>Safety population included participants in the ITT population who received at least 1 application of the investigational product. Here 'n' (number analyzed) signifies number of participants who were evaluable for each specified category. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5024 1% Cream</title>
            <description>Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O2">
            <title>CD5024 1% Cream Matched Placebo</title>
            <description>Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O3">
            <title>Adapalene Benzoyl Peroxyde</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.</description>
          </group>
          <group group_id="O4">
            <title>Adapalene Benzoyl Peroxyde Matched Placebo</title>
            <description>Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week&#xD;
1 to Week 5 and for 4 days during Week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)</title>
          <description>Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.</description>
          <population>Safety population included participants in the ITT population who received at least 1 application of the investigational product. Here 'n' (number analyzed) signifies number of participants who were evaluable for each specified category. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Face: Erythema: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Erythema: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Erythema: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Scaling/Desquamation: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Scaling/Desquamation: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Scaling/Desquamation: 2- Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Dryness: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Dryness: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Dryness: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Stinging/Burning: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Stinging/Burning: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face: Stinging/Burning: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Erythema: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Erythema: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Erythema: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Scaling/Desquamation: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Scaling/Desquamation: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Scaling/Desquamation: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Dryness: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Dryness: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Dryness: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Stinging/Burning: 0-None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Stinging/Burning: 1-Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear: Stinging/Burning: 2-Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study up to follow up (Week 7)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group I: CD5024 Cream Versus Its Vehicle</title>
          <description>Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
        </group>
        <group group_id="E2">
          <title>Group II: Epiduo Gel Versus Its Vehicle</title>
          <description>Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="48"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="48"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations</name_or_title>
      <organization>Galderma</organization>
      <phone>817 961 5000 ext +1</phone>
      <email>Clinical.Studies@galderma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03034460
org study id: RD.03.SPR.109807
nct id: NCT03034460
lead sponsor: 
has dmc: No
Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using
      intra-individual comparison involving subjects with acne vulgaris on face to evaluate the
      efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
Study drugs application will be performed once daily, 5 days a week during 6 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Inflammatory Lesion Count (Papules and Pustules) at Day 40
time frame: Day 40
description: Inflammatory lesion count corresponded to the sum of papules and pustules.
measure: Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
time frame: Baseline (Day 1)
description: Inflammatory lesion count corresponded to the sum of papules and pustules.
measure: Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
time frame: Baseline (Day 1), and Day 40
description: Inflammatory lesion count corresponded to the sum of papules and pustules.
measure: Total Lesion Count at Baseline (Day 1) and Day 40
time frame: Baseline (Day 1), and Day 40
description: Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
measure: Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
time frame: Baseline (Day 1), and Day 40
description: Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
measure: Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
time frame: Baseline (Day 1), and Day 40
description: Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
measure: Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
time frame: Baseline (Day 1), and Day 40
description: Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
measure: Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40
time frame: Day 40
description: The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.
measure: Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40
time frame: Day 40
description: The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.
measure: Number of Participants With Adverse Events (AEs)
time frame: From start of study up to follow up (Week 7)
description: AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
measure: Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
time frame: From Day 1 up Follow up (Week 7)
description: Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.
arm group label: CD5024 1% cream
arm group type: Experimental
description: Active drug;
arm group label: CD5024 cream placebo
arm group type: Placebo Comparator
description: Placebo of active drug;
arm group label: CD0271/CD1579 gel
arm group type: Other
description: Positive control;
arm group label: CD0271/CD1579 gel placebo
arm group type: Other
description: Placebo of positive control;
intervention type: Drug
intervention name: CD5024 1% cream
description: 500 µL on half-face, five days a week during 6 weeks
arm group label: CD5024 1% cream
intervention type: Drug
intervention name: CD5024 cream placebo
description: 500 µL on half-face, five days a week during 6 weeks
arm group label: CD5024 cream placebo
intervention type: Drug
intervention name: CD0271/CD1579 gel
description: 500 µL on half-face, five days a week during 6 weeks
arm group label: CD0271/CD1579 gel
intervention type: Drug
intervention name: CD0271/CD1579 gel placebo
description: 500 µL on half-face, five days a week during 6 weeks
arm group label: CD0271/CD1579 gel placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
country: Germany
responsible party type: Sponsor
mesh term: Acne Vulgaris
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 