<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/NCT03028363</url>
  </required_header>
  <id_info>
    <org_study_id>DRM01B-ACN03</org_study_id>
    <nct_id>NCT03028363</nct_id>
  </id_info>
  <brief_title>A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris</brief_title>
  <official_title>A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dermira, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil&#xD;
      Gel compared to vehicle in patients with acne vulgaris&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2016</start_date>
  <completion_date type="Actual">November 28, 2017</completion_date>
  <primary_completion_date type="Actual">November 28, 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12&#xD;
Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions&#xD;
- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion&#xD;
- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)&#xD;
- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion&#xD;
- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">759</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Olumacostat Glasaretil Gel, 5.0%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olumacostat Glasaretil Gel, Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olumacostat Glasaretil Gel, 5.0%</intervention_name>
    <description>Gel containing Olumacostat Glasaretil</description>
    <arm_group_label>Olumacostat Glasaretil Gel, 5.0%</arm_group_label>
    <other_name>DRM01</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Olumacostat Glasaretil Gel, Vehicle</intervention_name>
    <description>Vehicle (placebo) gel</description>
    <arm_group_label>Olumacostat Glasaretil Gel, Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent and, for subjects under legal adult age, signed assent&#xD;
&#xD;
          -  Age ≥ 9 years&#xD;
&#xD;
          -  Clinical diagnosis of facial acne vulgaris defined as:&#xD;
&#xD;
               -  At least 20 inflammatory lesions, and&#xD;
&#xD;
               -  At least 20 non-inflammatory lesions, and&#xD;
&#xD;
               -  Investigator Global Assessment of 3 or greater&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active cystic acne or acne conglobata, acne fulminans, and secondary acne&#xD;
&#xD;
          -  Two or more active nodulocystic lesions on the face&#xD;
&#xD;
          -  Clinically significant abnormal laboratory or ECG result&#xD;
&#xD;
          -  Subjects who are actively participating in an experimental therapy study or who have&#xD;
             received experimental therapy within 30 days or 5 half-lives (whichever is longer) of&#xD;
             the Baseline visit&#xD;
&#xD;
          -  Treatment with over-the-counter topical medications for the treatment of acne vulgaris&#xD;
             including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,&#xD;
             α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline&#xD;
&#xD;
          -  Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid&#xD;
             within 4 weeks prior to Baseline&#xD;
&#xD;
          -  Treatment with a new hormonal therapy or dose change to existing hormonal therapy&#xD;
             within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to,&#xD;
             estrogenic and progestational agents such as birth control pills).&#xD;
&#xD;
          -  Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks&#xD;
             prior to Baseline.&#xD;
&#xD;
          -  Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A&#xD;
             supplements greater than 10,000 units/day within 6 months prior to Baseline&#xD;
&#xD;
          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8&#xD;
             weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beth Zib</last_name>
    <role>Study Director</role>
    <affiliation>Dermira, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alliance Dermatology &amp; MOHS Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Research Associates</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital UCSD Pediatric and Adolescent Derm</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Trials Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizons Clinical Research Center, LLC</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Physicians of CT</name>
      <address>
        <city>Shelton</city>
        <state>Connecticut</state>
        <zip>06484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finlay Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness, Inc</name>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research-US, LLC</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenus Research &amp; Medical Group</name>
      <address>
        <city>Sweetwater</city>
        <state>Florida</state>
        <zip>33172</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the Southeast, LLC</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Dermatology</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forefront Dermatology</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Dermatology, PA</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Sciences, PLLC</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence Jeffrey Green MD, LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Group, Inc</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Research</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Clinical Research Inc</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acne Treatment &amp; Research Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schweiger Dermatology, PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearchCenter of New York, Inc.</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3rgy Research</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Partners, LLC</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clincial Research</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research - Tennessee LLC</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research-Tennesse LLC</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J &amp;S Studies, Inc</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus US, LP, dba, Research Across America</name>
      <address>
        <city>Murphy</city>
        <state>Texas</state>
        <zip>75094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research, PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Clinical Research Center of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woden Dermatology</name>
      <address>
        <city>Phillip</city>
        <state>Australian Capital Territory</state>
        <zip>2606</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Dermatology and Skin Cancer Centre</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Eastern Health Specialists</name>
      <address>
        <city>Hectorville</city>
        <state>South Australia</state>
        <zip>5073</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin &amp; Cancer Foundation Inc.</name>
      <address>
        <city>Carlton</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fremantle Dermatology</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Skin Advancement</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3A 2N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SimcoDerm Medical and Surgical Dermatology Center</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 7G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynderm Research Inc.</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 1X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bay Dermatology Centre</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <zip>P1B 3Z7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4W 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windsor Research Inc.</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 5L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>November 28, 2018</results_first_submitted>
  <results_first_submitted_qc>February 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2019</results_first_posted>
  <last_update_submitted>July 16, 2021</last_update_submitted>
  <last_update_submitted_qc>July 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</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>
  <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>October 6, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03028363/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>January 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03028363/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Olumacostat Glasaretil Gel, 5.0%</title>
          <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Olumacostat Glasaretil Gel, Vehicle</title>
          <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the 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="498"/>
                <participants group_id="P2" count="261"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="420"/>
                <participants group_id="P2" count="228"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Olumacostat Glasaretil Gel, 5.0%</title>
          <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Olumacostat Glasaretil Gel, Vehicle</title>
          <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the 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="498"/>
            <count group_id="B2" value="261"/>
            <count group_id="B3" value="759"/>
          </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="289"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="429"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="330"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>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="19.4" spread="6.58"/>
                    <measurement group_id="B2" value="20.1" spread="7.14"/>
                    <measurement group_id="B3" value="19.7" spread="6.78"/>
                  </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="286"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="438"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="321"/>
                  </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="150"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="218"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="346"/>
                    <measurement group_id="B2" value="193"/>
                    <measurement group_id="B3" value="539"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="373"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="564"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="40"/>
                  </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>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="431"/>
                    <measurement group_id="B2" value="226"/>
                    <measurement group_id="B3" value="657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <description>Fitzpatrick Skin Type is a scale to numerically classify skin color, defined by the response to ultraviolet (UV) light with the following categories:&#xD;
Type I Burns easily, rarely tans Type II Burns easily, tans minimally Type III Burns moderately, tans gradually Type IV Burns minimally, tans well Type V Rarely burns, tans profusely Type VI Never burns, deeply pigmented</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Type I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type V</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type VI</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12</title>
        <description>Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent-to-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Olumacostat Glasaretil Gel, 5.0%</title>
            <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Olumacostat Glasaretil Gel, Vehicle</title>
            <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12</title>
          <description>Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12</description>
          <population>Intent-to-Treat</population>
          <units>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="498"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.5" spread="14.85"/>
                    <measurement group_id="O2" value="-13.5" spread="14.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3430</p_value>
            <method>ANCOVA</method>
            <method_desc>Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12</title>
        <description>Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent-to-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Olumacostat Glasaretil Gel, 5.0%</title>
            <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Olumacostat Glasaretil Gel, Vehicle</title>
            <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12</title>
          <description>Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12</description>
          <population>Intent-to-Treat</population>
          <units>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="498"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.1" spread="21.05"/>
                    <measurement group_id="O2" value="-11.8" spread="20.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1260</p_value>
            <method>ANCOVA</method>
            <method_desc>Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12</title>
        <description>Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12&#xD;
Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions&#xD;
- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion&#xD;
- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)&#xD;
- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion&#xD;
- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent-to-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Olumacostat Glasaretil Gel, 5.0%</title>
            <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Olumacostat Glasaretil Gel, Vehicle</title>
            <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12</title>
          <description>Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12&#xD;
Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions&#xD;
- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion&#xD;
- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)&#xD;
- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion&#xD;
- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions</description>
          <population>Intent-to-Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="498"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403"/>
                    <measurement group_id="O2" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5247</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Week 12</time_frame>
      <desc>The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Olumacostat Glasaretil Gel, 5.0%</title>
          <description>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Olumacostat Glasaretil Gel, Vehicle</title>
          <description>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="485"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <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="89" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site dryness</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company.</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT03028363
org study id: DRM01B-ACN03
nct id: NCT03028363
lead sponsor: 
has dmc: No
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil
      Gel compared to vehicle in patients with acne vulgaris
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
time frame: Baseline and Week 12
description: Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
measure: Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
time frame: Baseline and Week 12
description: Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
measure: Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
time frame: Baseline and Week 12
description: Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12
Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions
- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion
- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
arm group label: Olumacostat Glasaretil Gel, 5.0%
arm group type: Experimental
description: Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
arm group label: Olumacostat Glasaretil Gel, Vehicle
arm group type: Placebo Comparator
description: Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
intervention type: Drug
intervention name: Olumacostat Glasaretil Gel, 5.0%
description: Gel containing Olumacostat Glasaretil
arm group label: Olumacostat Glasaretil Gel, 5.0%
other name: DRM01
intervention type: Other
intervention name: Olumacostat Glasaretil Gel, Vehicle
description: Vehicle (placebo) gel
arm group label: Olumacostat Glasaretil Gel, Vehicle
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: Beth Zib
role: Study Director
affiliation: Dermira, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 