<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/NCT02249104</url>
  </required_header>
  <id_info>
    <org_study_id>GLI.04.SPR.US10302</org_study_id>
    <nct_id>NCT02249104</nct_id>
  </id_info>
  <brief_title>A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris</brief_title>
  <official_title>Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump, Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foam Wash Regimen in Student Athletes With Mild to Moderate 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>
      The goal of this study is to evaluate a complete topical acne regimen consisting of a&#xD;
      prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil®&#xD;
      DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer&#xD;
      SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall purpose of this study was to demonstrate lesion count reduction from baseline,&#xD;
      subject satisfaction, and compliance with a regimen of adapalene BPO used in conjunction with&#xD;
      a foam wash and moisturizer with sunscreen in student athletes. The study hypothesis was that&#xD;
      this regimen would reduce total lesion count (inflammatory and noninflammatory) relative to&#xD;
      baseline. The objective of this study was to evaluate the change in lesion count (total,&#xD;
      inflammatory, and noninflammatory) in subjects using the CoMMPlete regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Total Lesion Count</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Lesion Count</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Inflammatory Lesion Count</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Non-inflammatory Lesion Count</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Inflammatory Lesion Count</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-inflammatory Lesion Count</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Acne treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adapalene/benzoyl peroxide gel, 0.1%/2.5%</intervention_name>
    <description>Topical AV therapy</description>
    <arm_group_label>Acne treatment</arm_group_label>
    <other_name>Epiduo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cetaphil Acne Regimen</intervention_name>
    <description>Cleanse, Moisturize, and Protect</description>
    <arm_group_label>Acne treatment</arm_group_label>
    <other_name>Cetaphil DermaControl Foam Wash</other_name>
    <other_name>Cetaphil DermaControl Moisturizer SPF 30</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and females aged 12 years and older who are actively participating in one of 14&#xD;
             Texas University Interscholastic League (UIL) sanctioned athletic activities at the&#xD;
             baseline visit (Baseball; Basketball; Cross Country; Football; Golf; Soccer; Softball;&#xD;
             Swimming and Diving; Team Tennis; Tennis; Track and Field; Volleyball; and Wrestling).&#xD;
&#xD;
          2. Subjects who agree to be photographed at each visit.&#xD;
&#xD;
          3. Diagnosed with acne vulgaris by a BCD and eligible for treatment with Epiduo®&#xD;
             (adapalene and benzoyl peroxide) Gel 0.1%/2.5% per PI.&#xD;
&#xD;
          4. Female subjects must have a negative urine pregnancy test (UPT) at Baseline/Visit 1,&#xD;
             must be willing to have this test performed at the clinic, and must agree to practice&#xD;
             one form of effective methods of non-hormonal contraception for the duration of the&#xD;
             study which include: abstinence, IUD (inserted 30 days prior to baseline),&#xD;
             double-barrier method, bilateral tubal ligation, or vasectomized partner (at least 90&#xD;
             days prior to baseline).&#xD;
&#xD;
          5. A minimum of 20 but not more than 50 inflammatory (papules and pustules) lesions on&#xD;
             the face (excluding the nose) and a minimum of 30 but not more than 100&#xD;
             noninflammatory lesions (open comedones and closed comedones) on the face (excluding&#xD;
             the nose).&#xD;
&#xD;
          6. Agree to use the provided study products as their only acne treatment, facial wash and&#xD;
             facial moisturizer for the duration of the study.&#xD;
&#xD;
          7. Agree to refrain from temporary and permanent tattoos, paint, or other facial art&#xD;
             (including, but not limited to piercings), cosmetic procedures and devices (including,&#xD;
             but not limited to facial peels, microdermabrasion and Clarisonic®) on the face for&#xD;
             the duration of the study.&#xD;
&#xD;
          8. Subjects aged 12-17 must be willing to read and provide written informed&#xD;
             consent/assent in conjunction with a parent/legal guardian who is able and willing to&#xD;
             read and provide written consent prior to any study related procedure or subjects aged&#xD;
             18 and older must be willing to read and provide written informed consent prior to any&#xD;
             study related procedures.&#xD;
&#xD;
          9. Subjects apprised of the Health Insurance Portability and Accountability Act of 1996&#xD;
             (HIPAA) and applicable state Bill of Rights and are willing to share personal&#xD;
             information and data, as verified by signing a written authorization at Screening.&#xD;
&#xD;
         10. Subjects must be willing and able to attend study visits and fulfill dosing&#xD;
             requirements.&#xD;
&#xD;
         11. Subjects able to follow study instructions and likely to complete all required visits.&#xD;
             In particular, subjects must agree to adhere to the visit schedule and be compliant&#xD;
             with the treatment regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with nodules and cysts.&#xD;
&#xD;
          2. Female subjects who are pregnant, nursing or planning a pregnancy during the study.&#xD;
&#xD;
          3. Subjects with facial hair, abnormal pigmented vascular skin lesions, abnormal skin&#xD;
             pigmentation, or body art (tattoos, permanent or temporary) on the face, which could&#xD;
             interfere with subsequent evaluations of dermal responsiveness.&#xD;
&#xD;
          4. Subjects with any systemic or dermatological disorder, a known history of allergies or&#xD;
             other medical conditions, which in the opinion of the principal investigator/BCD,&#xD;
             could interfere with the conduct of the study, interpretation of results or increase&#xD;
             the risk of adverse reactions.&#xD;
&#xD;
          5. Subjects with any known allergies to any of the ingredients listed on the study&#xD;
             product labels (refer to study product&quot;s PI and/or current labelling).&#xD;
&#xD;
          6. Subjects who have participated in another interventional, investigational drug or&#xD;
             device research study within 30 days of enrollment.&#xD;
&#xD;
          7. Study site staff or sponsor staff, relatives of site staff or sponsor, or other&#xD;
             individuals who would have access to the clinical study protocol.&#xD;
&#xD;
          8. Subjects with a washout period less than 1 week for over-the-counter topical acne&#xD;
             treatments (with active ingredients such as Benzoyl Peroxide, Salicylic Acid, Sulfur&#xD;
             and Resorcinol), prescription topical acne treatment and topical corticosteroids, and&#xD;
             use of cosmetic devices (such as Clarisonic® or similar) and less than 4 weeks for&#xD;
             topical retinoids.&#xD;
&#xD;
          9. Subjects with a washout period less than 4 weeks for systemic prescription acne&#xD;
             treatment and systemic corticosteroids and less than 24 weeks for oral retinoids.&#xD;
&#xD;
         10. Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis,&#xD;
             rosacea, or other topical conditions on the area to be treated.&#xD;
&#xD;
         11. Subjects who are at risk in terms of precautions, warnings, and contra-indications&#xD;
             (refer to the study product&quot;s PI and current labelling).&#xD;
&#xD;
         12. Subjects who foresee unprotected and intense UV exposure during the study (mountain&#xD;
             sports, UV radiation, sunbathing, etc.).&#xD;
&#xD;
         13. Subjects with any visible skin condition or facial hair that could interfere with the&#xD;
             evaluations.&#xD;
&#xD;
         14. Subjects taking or planning to take topical or systemic medications to treat acne&#xD;
             during the course of the study.&#xD;
&#xD;
         15. Subjects taking other medications, supplements, or non-prescription treatments that,&#xD;
             in the opinion of the principal investigator/BCD, could interfere with the test&#xD;
             results including any regimen of steroidal/non-steroidal anti-inflammatory drugs, or&#xD;
             antihistamines, or anabolic steroids.&#xD;
&#xD;
         16. Subjects currently under the treatment for asthma or diabetes (insulin-dependent&#xD;
             only).&#xD;
&#xD;
         17. Subjects with planned surgical or cosmetic procedures of the face during the course of&#xD;
             the study.&#xD;
&#xD;
         18. Subjects with a history of procedures such as microdermabrasion, chemical peels,&#xD;
             intense pulsed light, fillers, Botox®, lasers, photodynamic therapy, red and blue&#xD;
             light therapy, etc. in the last 90 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward Lain, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pflugerville Dermatology Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pflugerville Dermatology Clinical Research</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>March 18, 2016</results_first_submitted>
  <results_first_submitted_qc>April 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 26, 2016</results_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adapalene</mesh_term>
    <mesh_term>Adapalene, Benzoyl Peroxide Drug Combination</mesh_term>
    <mesh_term>Benzoyl Peroxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First subject, first visit: 20 Aug 2014; Single center study</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Acne Treatment</title>
          <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Acne Treatment</title>
          <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Total Lesion Count</title>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acne Treatment</title>
            <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Total Lesion Count</title>
          <units>Lesions counted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.9" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Lesion Count</title>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acne Treatment</title>
            <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Lesion Count</title>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.6" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Inflammatory Lesion Count</title>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acne Treatment</title>
            <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Inflammatory Lesion Count</title>
          <units>Lesions counted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.8" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Non-inflammatory Lesion Count</title>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acne Treatment</title>
            <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Non-inflammatory Lesion Count</title>
          <units>Lesions counted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.3" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Inflammatory Lesion Count</title>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acne Treatment</title>
            <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Inflammatory Lesion Count</title>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.7" spread="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-inflammatory Lesion Count</title>
        <time_frame>Baseline and 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acne Treatment</title>
            <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-inflammatory Lesion Count</title>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.1" spread="34.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Acne Treatment</title>
          <description>Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily&#xD;
Cetaphil Acne Regimen:&#xD;
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application&#xD;
Cetaphil® DermaControl™ Foam Wash, at least twice daily&#xD;
Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy&#xD;
Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>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="18" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>External ear cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </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>Investigator may publish, present, or use any results that do not disclose any confidential information furnished by Galderma. The investigator shall provide their draft of such publication to sponsor for review and approval at least 45 days prior to the date of the intended publication. Upon written request from Galderma, within the forty-five (45) day review period, the investigator will delay the publication or presentation for a maximum of an additional one-hundred eighty (180) days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Open label study with small sample size&#xD;
Short duration</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Jay Mashburn</name_or_title>
      <organization>Galderma Laboratories L.P.</organization>
      <phone>817 961 5027</phone>
      <email>jay.mashburn@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/NCT02249104
org study id: GLI.04.SPR.US10302
nct id: NCT02249104
lead sponsor: 
has dmc: No
The goal of this study is to evaluate a complete topical acne regimen consisting of a
      prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil®
      DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer
      SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.
The overall purpose of this study was to demonstrate lesion count reduction from baseline,
      subject satisfaction, and compliance with a regimen of adapalene BPO used in conjunction with
      a foam wash and moisturizer with sunscreen in student athletes. The study hypothesis was that
      this regimen would reduce total lesion count (inflammatory and noninflammatory) relative to
      baseline. The objective of this study was to evaluate the change in lesion count (total,
      inflammatory, and noninflammatory) in subjects using the CoMMPlete regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change From Baseline in Total Lesion Count
time frame: Baseline and 8 weeks
measure: Percent Change From Baseline in Total Lesion Count
time frame: Baseline and 8 weeks
measure: Mean Change From Baseline in Inflammatory Lesion Count
time frame: Baseline and 8 weeks
measure: Mean Change From Baseline in Non-inflammatory Lesion Count
time frame: Baseline and 8 weeks
measure: Percent Change From Baseline in Inflammatory Lesion Count
time frame: Baseline and 8 weeks
measure: Percent Change From Baseline in Non-inflammatory Lesion Count
time frame: Baseline and 8 weeks
arm group label: Acne treatment
arm group type: Experimental
description: Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily
Cetaphil Acne Regimen:
Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application
Cetaphil® DermaControl™ Foam Wash, at least twice daily
intervention type: Drug
intervention name: Adapalene/benzoyl peroxide gel, 0.1%/2.5%
description: Topical AV therapy
arm group label: Acne treatment
other name: Epiduo
intervention type: Other
intervention name: Cetaphil Acne Regimen
description: Cleanse, Moisturize, and Protect
arm group label: Acne treatment
other name: Cetaphil DermaControl Foam Wash
other name: Cetaphil DermaControl Moisturizer SPF 30
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Edward Lain, MD
role: Principal Investigator
affiliation: Pflugerville Dermatology Clinical Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Adapalene
mesh term: Adapalene, Benzoyl Peroxide Drug Combination
mesh term: Benzoyl Peroxide
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Open label study with small sample size
Short duration
point of contact: 