<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/NCT03761784</url>
  </required_header>
  <id_info>
    <org_study_id>SGT-65-04</org_study_id>
    <nct_id>NCT03761784</nct_id>
  </id_info>
  <brief_title>A Study of S6G5T-3 in the Treatment of Acne Vulgaris</brief_title>
  <official_title>A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sol-Gel Technologies, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sol-Gel Technologies, Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12&#xD;
      weeks in participants with acne vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group&#xD;
      pivotal study, participants will be admitted only after a written informed consent has been&#xD;
      obtained and after all inclusion/exclusion criteria have been met. Male and female&#xD;
      participants at least 9 years of age with facial acne vulgaris will be eligible for&#xD;
      enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline</measure>
    <time_frame>Baseline through Week 12</time_frame>
    <description>Percentage of participants in each treatment group achieving an acne severity IGA score of &quot;clear (score=0)&quot; or &quot;almost clear (score=1)&quot; and achieving an acne severity IGA score of at least 2 grades less than Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pimples at all&quot;) to 10 (&quot;pimples as bad as you can imagine&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 (&quot;not embarrassed at all&quot;) to 10 (&quot;extremely embarrassed&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">424</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>S6G5T-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S6G5T-8 Vehicle Cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S6G5T-3</intervention_name>
    <description>Once a day topical cream</description>
    <arm_group_label>S6G5T-3</arm_group_label>
    <other_name>Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S6G5T-8</intervention_name>
    <description>Once a day topical cream</description>
    <arm_group_label>S6G5T-8 Vehicle Cream</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant must sign an Institutional Review Board (IRB) approved written informed&#xD;
             consent for this study.&#xD;
&#xD;
          2. Male and female 9 years of age and older.&#xD;
&#xD;
          3. Have 2 or fewer cysts or nodules.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or&#xD;
             equal to 5 millimeter (mm) in diameter).&#xD;
&#xD;
          2. Acne conglobata, acne fulminans, and secondary acne (for example, chloracne,&#xD;
             drug-induced acne).&#xD;
&#xD;
          3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia,&#xD;
             multiple myeloma).&#xD;
&#xD;
          4. Underlying disease that requires the use of interfering topical or systemic therapy.&#xD;
&#xD;
          5. Other dermatological conditions that require the use of interfering topical or&#xD;
             systemic therapy or that might interfere with study assessments such as, but not&#xD;
             limited to, atopic dermatitis, perioral dermatitis, or rosacea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology Consulting Services</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>November 2, 2021</results_first_submitted>
  <results_first_submitted_qc>November 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 1, 2021</results_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acne Vulgaris</keyword>
  <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>Tretinoin</mesh_term>
    <mesh_term>Benzoyl Peroxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03761784/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03761784/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were randomized to receive either S6G5T-3 (Encapsulated Benzoyl Peroxide [E-BPO] and Encapsulated Tretinoin [E-ATRA] Cream, 3%/0.1% [E-BPO/E-ATRA Cream, 3%/0.1%]) or vehicle in a 2:1 ratio.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>S6G5T-3</title>
          <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>S6G5T-8 Vehicle Cream</title>
          <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="281"/>
                <participants group_id="P2" count="143"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="274"/>
                <participants group_id="P2" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="249"/>
                <participants group_id="P2" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Parent or Guardian</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <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="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Than Specified</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>
      <population>The intent-to-treat (ITT) population consisted of all randomized participants who were dispensed study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>S6G5T-3</title>
          <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>S6G5T-8 Vehicle Cream</title>
          <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</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="281"/>
            <count group_id="B2" value="143"/>
            <count group_id="B3" value="424"/>
          </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="20.9" spread="8.48"/>
                    <measurement group_id="B2" value="21.4" spread="8.62"/>
                    <measurement group_id="B3" value="21.1" spread="8.52"/>
                  </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="175"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="258"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="178"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="303"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Acne Lesion Count on the Face</title>
          <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads).</description>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Inflammatory Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.5" spread="14.62"/>
                    <measurement group_id="B2" value="33.5" spread="14.69"/>
                    <measurement group_id="B3" value="33.5" spread="14.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Inflammatory lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.6" spread="20.24"/>
                    <measurement group_id="B2" value="47.1" spread="19.97"/>
                    <measurement group_id="B3" value="48.1" spread="20.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Investigator's Global Assessment (IGA)</title>
          <description>Investigator's Global Assessment (IGA), where Investigator's rated the participant's acne from 0 (Clear) to 4 (Severe). A higher score indicated an increase in severity of facial acne.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 - Clear</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>1 - Almost Clear</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>2 - Mild</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>3 - Moderate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="251"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="383"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 - Severe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline</title>
        <description>Percentage of participants in each treatment group achieving an acne severity IGA score of &quot;clear (score=0)&quot; or &quot;almost clear (score=1)&quot; and achieving an acne severity IGA score of at least 2 grades less than Baseline.</description>
        <time_frame>Baseline through Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (MCMC) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline</title>
          <description>Percentage of participants in each treatment group achieving an acne severity IGA score of &quot;clear (score=0)&quot; or &quot;almost clear (score=1)&quot; and achieving an acne severity IGA score of at least 2 grades less than Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (MCMC) was used to impute missing values.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12</title>
        <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12</title>
          <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Inflammatory Lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.6" spread="10.67"/>
                    <measurement group_id="O2" value="-14.8" spread="11.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12</title>
        <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12</title>
          <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Non-Inflammatory Lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.7" spread="15.26"/>
                    <measurement group_id="O2" value="-19.8" spread="15.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12</title>
        <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12</title>
          <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Percent Change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-61.6" spread="31.38"/>
                    <measurement group_id="O2" value="-40.9" spread="32.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12</title>
        <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12</title>
          <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Percent Change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-66.1" spread="32.28"/>
                    <measurement group_id="O2" value="-43.5" spread="32.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)</title>
        <description>Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pimples at all&quot;) to 10 (&quot;pimples as bad as you can imagine&quot;).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)</title>
          <description>Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pimples at all&quot;) to 10 (&quot;pimples as bad as you can imagine&quot;).</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9"/>
                    <measurement group_id="O2" value="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face</title>
        <description>Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 (&quot;not embarrassed at all&quot;) to 10 (&quot;extremely embarrassed&quot;).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face</title>
          <description>Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 (&quot;not embarrassed at all&quot;) to 10 (&quot;extremely embarrassed&quot;).</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.8"/>
                    <measurement group_id="O2" value="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8</title>
        <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8</title>
          <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Non-Inflammatory Lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.4" spread="16.44"/>
                    <measurement group_id="O2" value="-16.9" spread="15.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8</title>
        <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8</title>
          <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Inflammatory Lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.2" spread="12.10"/>
                    <measurement group_id="O2" value="-12.5" spread="11.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4</title>
        <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4</title>
          <description>Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Non-Inflammatory Lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.5" spread="14.16"/>
                    <measurement group_id="O2" value="-13.4" spread="13.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4</title>
        <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>S6G5T-3</title>
            <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>S6G5T-8 Vehicle Cream</title>
            <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4</title>
          <description>Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.</description>
          <population>The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.</population>
          <units>Inflammatory Lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.5" spread="10.32"/>
                    <measurement group_id="O2" value="-9.8" spread="10.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline (Day 0) through end of study (Week 12)</time_frame>
      <desc>Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.</desc>
      <group_list>
        <group group_id="E1">
          <title>S6G5T-3</title>
          <description>Participants topically applied S6G5T-3, once daily to face for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>S6G5T-8 Vehicle Cream</title>
          <description>Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.</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="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="69" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Application site dryness</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Application site exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Application site irritation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Attention deficit/hyperactivity disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="139"/>
              </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>Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sol-Gel</name_or_title>
      <organization>Sol-Gel Technologies, Ltd.</organization>
      <phone>972-8-9313433</phone>
      <email>info@sol-gel.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/NCT03761784
org study id: SGT-65-04
nct id: NCT03761784
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12
      weeks in participants with acne vulgaris.
In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group
      pivotal study, participants will be admitted only after a written informed consent has been
      obtained and after all inclusion/exclusion criteria have been met. Male and female
      participants at least 9 years of age with facial acne vulgaris will be eligible for
      enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
time frame: Baseline through Week 12
description: Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
measure: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
time frame: Baseline, Week 12
description: Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
measure: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
time frame: Baseline, Week 12
description: Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
measure: Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
time frame: Baseline, Week 12
description: Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
measure: Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
time frame: Baseline, Week 12
description: Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
measure: Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
time frame: Baseline and Week 12
description: Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").
measure: Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
time frame: Baseline and Week 12
description: Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").
measure: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
time frame: Baseline, Week 8
description: Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
measure: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
time frame: Baseline, Week 8
description: Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
measure: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
time frame: Baseline, Week 4
description: Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
measure: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
time frame: Baseline, Week 4
description: Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
arm group label: S6G5T-3
arm group type: Experimental
description: Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks.
arm group label: S6G5T-8 Vehicle Cream
arm group type: Placebo Comparator
description: Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.
intervention type: Drug
intervention name: S6G5T-3
description: Once a day topical cream
arm group label: S6G5T-3
other name: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)
intervention type: Drug
intervention name: S6G5T-8
description: Once a day topical cream
arm group label: S6G5T-8 Vehicle Cream
other name: Vehicle
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Tretinoin
mesh term: Benzoyl Peroxide
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 