<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/NCT02242760</url>
  </required_header>
  <id_info>
    <org_study_id>NI-AC202</org_study_id>
    <nct_id>NCT02242760</nct_id>
  </id_info>
  <brief_title>P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris</brief_title>
  <official_title>A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novan, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novan, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, multi-center, double-blinded study in subjects with moderate to severe&#xD;
      acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2&#xD;
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up&#xD;
      to 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, multi-center, double-blinded study in subjects with moderate to severe acne&#xD;
      vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2&#xD;
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up&#xD;
      to 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change in Inflammatory Lesion Counts</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Change in inflammatory lesion count from Baseline to Week 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change in Non-inflammatory Lesion Counts</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Absolute Change in non-inflammatory lesion count from Baseline to Week 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.&#xD;
Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Inflammatory Lesion Count From Baseline to Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The percent change in inflammatory lesion count from Baseline to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The percent change in non-inflammatory lesion count from Baseline to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Improvement</measure>
    <time_frame>Baseline through Week 12</time_frame>
    <description>Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>SB204 2% Twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily SB204 2%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SB204 4% daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily SB204 4%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Gel Daily</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle Gel Daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Gel Twice Daily</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twice daily Vehicle Gel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SB204 4% Twice Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily SB204 4%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB204 2%</intervention_name>
    <description>Applied topically twice daily</description>
    <arm_group_label>SB204 2% Twice daily</arm_group_label>
    <other_name>NVN1000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB204 4%</intervention_name>
    <description>Applied topically daily</description>
    <arm_group_label>SB204 4% Twice Daily</arm_group_label>
    <arm_group_label>SB204 4% daily</arm_group_label>
    <other_name>NVN1000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Gel</intervention_name>
    <description>Applied topically twice and once daily</description>
    <arm_group_label>Vehicle Gel Daily</arm_group_label>
    <arm_group_label>Vehicle Gel Twice Daily</arm_group_label>
    <other_name>Placeco</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe acne&#xD;
&#xD;
          -  25-70 non-inflammatory lesions at Baseline&#xD;
&#xD;
          -  20-40 inflammatory lesions at Baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known allergy to any component of the test material or vehicle&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M J Rico, MD</last_name>
    <role>Study Director</role>
    <affiliation>Novan, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qst acne site #1</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #118</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #111</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #113</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #119</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #103</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site # 110</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site # 116</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>302636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #117</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #112</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #120</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site # 121</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #107</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #108</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #109</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #104</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site # 102</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #106</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST #105</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QST Site #114</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>March 20, 2023</results_first_submitted>
  <results_first_submitted_qc>May 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2023</results_first_posted>
  <disposition_first_submitted>December 18, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>December 18, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 20, 2017</disposition_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acne</keyword>
  <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 16, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT02242760/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>May 19, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT02242760/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vehicle Gel QD</title>
          <description>Vehicle Gel: Applied topically once daily</description>
        </group>
        <group group_id="P2">
          <title>Vehicle Gel BID</title>
          <description>Vehicle Gel: Applied topically twice daily</description>
        </group>
        <group group_id="P3">
          <title>SB204 2% BID</title>
          <description>SB204 2%: Applied topically twice daily</description>
        </group>
        <group group_id="P4">
          <title>SB204 4% QD</title>
          <description>SB204 4%: Applied topically once daily</description>
        </group>
        <group group_id="P5">
          <title>SB204 4% BID</title>
          <description>SB204 4%: Applied topically twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="52"/>
                <participants group_id="P5" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Subjects Excluded From ITT Population</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="48"/>
                <participants group_id="P5" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat (ITT) population: all study subjects who were randomized and dispensed study medication. One subject in the SB204 4% BID group was randomized but did not receive study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Vehicle Gel QD</title>
          <description>Vehicle Gel: Applied topically once daily</description>
        </group>
        <group group_id="B2">
          <title>Vehicle Gel BID</title>
          <description>Vehicle Gel: Applied topically twice daily</description>
        </group>
        <group group_id="B3">
          <title>SB204 2% BID</title>
          <description>SB204 2%: Applied topically twice daily</description>
        </group>
        <group group_id="B4">
          <title>SB204 4% QD</title>
          <description>SB204 4%: Applied topically once daily</description>
        </group>
        <group group_id="B5">
          <title>SB204 4% BID</title>
          <description>SB204 4%: Applied topically twice daily</description>
        </group>
        <group group_id="B6">
          <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="27"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="53"/>
            <count group_id="B4" value="52"/>
            <count group_id="B5" value="51"/>
            <count group_id="B6" value="212"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>SB204</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="20.1" spread="6.81"/>
                    <measurement group_id="B4" value="18.8" spread="5.00"/>
                    <measurement group_id="B5" value="20.1" spread="6.94"/>
                    <measurement group_id="B6" value="19.6" spread="6.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vehicle</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.7" spread="4.84"/>
                    <measurement group_id="B2" value="19.7" spread="6.33"/>
                    <measurement group_id="B6" value="18.2" spread="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>SB204</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="29"/>
                    <measurement group_id="B6" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vehicle</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B6" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B6" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>SB204</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vehicle</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B6" value="48"/>
                  </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="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>The Statistical Analysis Plan specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. For the SB204 cohorts, columns 3, 4, and 5 represent the individual cohorts, while column 6 represents the combined SB204 information. The individual vehicle gel cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>SB204</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="36"/>
                    <measurement group_id="B6" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vehicle</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B6" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B6" value="3"/>
                  </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="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>The SAP specified that demographic data would be presented by the individual cohorts, the combined SB204 cohorts and the combined vehicle cohort. The SB204 cohorts are presented in Row 1--columns 3, 4, and 5 represent the individual SB204 cohorts, while column 6 represents the combined SB204 cohort. The vehicle gel cohorts are presented in Row 2. The individual vehicle cohorts are presented in columns 1 and 2, while the combined vehicle gel cohort information is in column 6.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="53"/>
                    <count group_id="B4" value="52"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>SB204</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="52"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vehicle</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in Inflammatory Lesion Counts</title>
        <description>Change in inflammatory lesion count from Baseline to Week 12</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent to treat population (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle Gel QD</title>
            <description>Vehicle Gel: Applied topically once daily</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel BID</title>
            <description>Vehicle Gel: Applied topically twice daily</description>
          </group>
          <group group_id="O3">
            <title>SB204 2% BID</title>
            <description>SB204 2%: Applied topically twice daily</description>
          </group>
          <group group_id="O4">
            <title>SB204 4% QD</title>
            <description>SB204 4%: Applied topically once daily</description>
          </group>
          <group group_id="O5">
            <title>SB204 4% BID</title>
            <description>SB204 4%: Applied topically twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Inflammatory Lesion Counts</title>
          <description>Change in inflammatory lesion count from Baseline to Week 12</description>
          <population>Intent to treat population (ITT)</population>
          <units>inflammatory acne lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="52"/>
                <count group_id="O5" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.7" spread="10.51"/>
                    <measurement group_id="O2" value="-4.1" spread="12.77"/>
                    <measurement group_id="O3" value="-11.2" spread="9.48"/>
                    <measurement group_id="O4" value="-11.3" spread="9.66"/>
                    <measurement group_id="O5" value="-10.4" spread="9.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in Non-inflammatory Lesion Counts</title>
        <description>Absolute Change in non-inflammatory lesion count from Baseline to Week 12</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent to treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle Gel QD</title>
            <description>Vehicle Gel: Applied topically once daily</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel BID</title>
            <description>Vehicle Gel: Applied topically twice daily</description>
          </group>
          <group group_id="O3">
            <title>SB204 2% BID</title>
            <description>SB204 2%: Applied topically twice daily</description>
          </group>
          <group group_id="O4">
            <title>SB204 4% QD</title>
            <description>SB204 4%: Applied topically once daily</description>
          </group>
          <group group_id="O5">
            <title>SB204 4% BID</title>
            <description>SB204 4%: Applied topically twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Non-inflammatory Lesion Counts</title>
          <description>Absolute Change in non-inflammatory lesion count from Baseline to Week 12</description>
          <population>Intent to treat (ITT) population</population>
          <units>non-inflammatory acne lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="52"/>
                <count group_id="O5" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="16.16"/>
                    <measurement group_id="O2" value="-6.9" spread="18.16"/>
                    <measurement group_id="O3" value="-12.3" spread="14.91"/>
                    <measurement group_id="O4" value="-14.1" spread="15.13"/>
                    <measurement group_id="O5" value="-11.1" spread="17.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment</title>
        <description>Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.&#xD;
Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle Gel QD</title>
            <description>Vehicle Gel: Applied topically once daily</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel BID</title>
            <description>Vehicle Gel: Applied topically twice daily</description>
          </group>
          <group group_id="O3">
            <title>SB204 2% BID</title>
            <description>SB204 2%: Applied topically twice daily</description>
          </group>
          <group group_id="O4">
            <title>SB204 4% QD</title>
            <description>SB204 4%: Applied topically once daily</description>
          </group>
          <group group_id="O5">
            <title>SB204 4% BID</title>
            <description>SB204 4%: Applied topically twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment</title>
          <description>Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.&#xD;
Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)</description>
          <population>Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline.</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="27"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="52"/>
                <count group_id="O5" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Inflammatory Lesion Count From Baseline to Week 12</title>
        <description>The percent change in inflammatory lesion count from Baseline to Week 12</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent to treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle Gel QD</title>
            <description>Vehicle Gel: Applied topically once daily</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel BID</title>
            <description>Vehicle Gel: Applied topically twice daily</description>
          </group>
          <group group_id="O3">
            <title>SB204 2% BID</title>
            <description>SB204 2%: Applied topically twice daily</description>
          </group>
          <group group_id="O4">
            <title>SB204 4% QD</title>
            <description>SB204 4%: Applied topically once daily</description>
          </group>
          <group group_id="O5">
            <title>SB204 4% BID</title>
            <description>SB204 4%: Applied topically twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Inflammatory Lesion Count From Baseline to Week 12</title>
          <description>The percent change in inflammatory lesion count from Baseline to Week 12</description>
          <population>Intent to treat (ITT) population</population>
          <units>Percentage change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="52"/>
                <count group_id="O5" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.2" spread="34.78"/>
                    <measurement group_id="O2" value="-12.5" spread="48.25"/>
                    <measurement group_id="O3" value="-41.9" spread="31.35"/>
                    <measurement group_id="O4" value="-41.6" spread="36.6"/>
                    <measurement group_id="O5" value="-42.1" spread="35.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12</title>
        <description>The percent change in non-inflammatory lesion count from Baseline to Week 12</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Intent to treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle Gel QD</title>
            <description>Vehicle Gel: Applied topically once daily</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Gel BID</title>
            <description>Vehicle Gel: Applied topically twice daily</description>
          </group>
          <group group_id="O3">
            <title>SB204 2% BID</title>
            <description>SB204 2%: Applied topically twice daily</description>
          </group>
          <group group_id="O4">
            <title>SB204 4% QD</title>
            <description>SB204 4%: Applied topically once daily</description>
          </group>
          <group group_id="O5">
            <title>SB204 4% BID</title>
            <description>SB204 4%: Applied topically twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12</title>
          <description>The percent change in non-inflammatory lesion count from Baseline to Week 12</description>
          <population>Intent to treat (ITT) population</population>
          <units>Percentage change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="52"/>
                <count group_id="O5" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.2" spread="42.54"/>
                    <measurement group_id="O2" value="-14.3" spread="54.10"/>
                    <measurement group_id="O3" value="-33.8" spread="33.91"/>
                    <measurement group_id="O4" value="-36.8" spread="35.54"/>
                    <measurement group_id="O5" value="-33.0" spread="40.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Improvement</title>
        <description>Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.</description>
        <time_frame>Baseline through Week 12</time_frame>
        <population>Intent to treat (ITT) population. The vehicle QD and vehicle BID arms were combined per the study Statistical Analysis Plan: &quot;Median time to improvement will be calculated using the Kaplan-Meier method, and the Kaplan-Meier curves will be presented for each active treatment group and the combined Vehicle group.&quot;</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Vehicle</title>
            <description>Vehicle Gel applied once or twice daily according to randomization</description>
          </group>
          <group group_id="O2">
            <title>SB204 2% BID</title>
            <description>SB204 2%: Applied topically twice daily</description>
          </group>
          <group group_id="O3">
            <title>SB204 4% QD</title>
            <description>SB204 4%: Applied topically once daily</description>
          </group>
          <group group_id="O4">
            <title>SB204 4% BID</title>
            <description>SB204 4%: Applied topically twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Improvement</title>
          <description>Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.</description>
          <population>Intent to treat (ITT) population. The vehicle QD and vehicle BID arms were combined per the study Statistical Analysis Plan: &quot;Median time to improvement will be calculated using the Kaplan-Meier method, and the Kaplan-Meier curves will be presented for each active treatment group and the combined Vehicle group.&quot;</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="1.4" upper_limit="12.1"/>
                    <measurement group_id="O2" value="2.0" lower_limit="2.0" upper_limit="14"/>
                    <measurement group_id="O3" value="4.1" lower_limit="1.7" upper_limit="12.3"/>
                    <measurement group_id="O4" value="4.0" lower_limit="1.6" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vehicle Gel QD</title>
          <description>Vehicle Gel: Applied topically once daily</description>
        </group>
        <group group_id="E2">
          <title>Vehicle Gel BID</title>
          <description>Vehicle Gel: Applied topically twice daily</description>
        </group>
        <group group_id="E3">
          <title>SB204 2% BID</title>
          <description>SB204 2%: Applied topically twice daily</description>
        </group>
        <group group_id="E4">
          <title>SB204 4% QD</title>
          <description>SB204 4%: Applied topically once daily</description>
        </group>
        <group group_id="E5">
          <title>SB204 4% BID</title>
          <description>SB204 4%: Applied topically twice daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <description>Event required hospitalization; considered unlikely to be related to study drug.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="51"/>
              </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="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="51"/>
              </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>Cathy White, Vice President, Drug Development Operations</name_or_title>
      <organization>Novan, Inc.</organization>
      <phone>919-485-8080</phone>
      <email>clinical@novan.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/NCT02242760
org study id: NI-AC202
nct id: NCT02242760
lead sponsor: 
has dmc: No
This is a randomized, multi-center, double-blinded study in subjects with moderate to severe
      acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up
      to 12 weeks.
A randomized, multi-center, double-blinded study in subjects with moderate to severe acne
      vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up
      to 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Absolute Change in Inflammatory Lesion Counts
time frame: Baseline and Week 12
description: Change in inflammatory lesion count from Baseline to Week 12
measure: Absolute Change in Non-inflammatory Lesion Counts
time frame: Baseline and Week 12
description: Absolute Change in non-inflammatory lesion count from Baseline to Week 12
measure: Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
time frame: Baseline and Week 12
description: Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.
Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)
measure: Percent Change in Inflammatory Lesion Count From Baseline to Week 12
time frame: Baseline and Week 12
description: The percent change in inflammatory lesion count from Baseline to Week 12
measure: Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
time frame: Baseline and Week 12
description: The percent change in non-inflammatory lesion count from Baseline to Week 12
measure: Median Time to Improvement
time frame: Baseline through Week 12
description: Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.
arm group label: SB204 2% Twice daily
arm group type: Experimental
description: Twice daily SB204 2%
arm group label: SB204 4% daily
arm group type: Experimental
description: Once daily SB204 4%
arm group label: Vehicle Gel Daily
arm group type: Placebo Comparator
description: Vehicle Gel Daily
arm group label: Vehicle Gel Twice Daily
arm group type: Placebo Comparator
description: Twice daily Vehicle Gel
arm group label: SB204 4% Twice Daily
arm group type: Experimental
description: Twice daily SB204 4%
intervention type: Drug
intervention name: SB204 2%
description: Applied topically twice daily
arm group label: SB204 2% Twice daily
other name: NVN1000
intervention type: Drug
intervention name: SB204 4%
description: Applied topically daily
arm group label: SB204 4% Twice Daily
arm group label: SB204 4% daily
other name: NVN1000
intervention type: Drug
intervention name: Vehicle Gel
description: Applied topically twice and once daily
arm group label: Vehicle Gel Daily
arm group label: Vehicle Gel Twice Daily
other name: Placeco
criteria: 
gender: All
minimum age: 12 Years
maximum age: 40 Years
healthy volunteers: No
last name: M J Rico, MD
role: Study Director
affiliation: Novan, Inc.
facility: 
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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: 