<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/NCT01701024</url>
  </required_header>
  <id_info>
    <org_study_id>V01-ACYC-301</org_study_id>
    <nct_id>NCT01701024</nct_id>
  </id_info>
  <brief_title>Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne</brief_title>
  <acronym>ACYC</acronym>
  <official_title>A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of ACYC and ACYC Vehicle Gel in the Treatment of Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dow Pharmaceutical Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bausch Health Americas, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare the efficacy and safety and tolerability of&#xD;
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to compare the efficacy and safety and tolerability of&#xD;
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change in Inflammatory Lesion Count</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change in Non-inflammatory Lesion Count</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Subjects Who Have a Least a 2 Grade Reduction</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">498</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>ACYC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACYC active, topically applied to the face for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACYC vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACYC</intervention_name>
    <description>ACYC active, topically applied to the face for 12 weeks</description>
    <arm_group_label>ACYC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACYC vehicle</intervention_name>
    <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
    <arm_group_label>ACYC vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between the ages of 12 and 40 (inclusive)&#xD;
&#xD;
          -  Written and verbal informed consent must be obtained.&#xD;
&#xD;
          -  Subjects less than 18 years of age must sign an assent for the study and a parent or a&#xD;
             legal guardian must sign the informed consent&#xD;
&#xD;
          -  Subject must have moderate to severe acne at the baseline visit&#xD;
&#xD;
          -  Women of childbearing potential must be willing to practice effective contraception&#xD;
             for the duration of the study&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Use of an investigational drug or device within 30 days of enrollment or participation&#xD;
             in a research study concurrent with this study&#xD;
&#xD;
          -  Dermatological conditions on the face that could interfere with clinical evaluations&#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>Nilima Justice, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Medical Monitor, Valeant Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goodlettsville</city>
        <state>Tennessee</state>
        <zip>37072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <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 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>January 15, 2015</results_first_submitted>
  <results_first_submitted_qc>November 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 10, 2017</results_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2018</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ACYC</title>
          <description>ACYC active, topically applied to the face for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>ACYC Vehicle</title>
          <description>ACYC vehicle (placebo), topically applied 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="253"/>
                <participants group_id="P2" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="243"/>
                <participants group_id="P2" count="236"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ACYC</title>
          <description>ACYC active, topically applied to the face for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>ACYC Vehicle</title>
          <description>ACYC vehicle (placebo), topically applied 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="253"/>
            <count group_id="B2" value="245"/>
            <count group_id="B3" value="498"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.2" spread="5.6"/>
                    <measurement group_id="B2" value="19.3" spread="6"/>
                    <measurement group_id="B3" value="18.7" spread="5.82"/>
                  </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="123"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="242"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="256"/>
                  </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="64"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="362"/>
                  </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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="208"/>
                    <measurement group_id="B2" value="210"/>
                    <measurement group_id="B3" value="418"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </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>Inflammatory Lesion Count</title>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.2" spread="5.99"/>
                    <measurement group_id="B2" value="26.7" spread="6.09"/>
                    <measurement group_id="B3" value="27" spread="6.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-Inflammatory Lesion Count</title>
          <units>Lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.3" spread="18.63"/>
                    <measurement group_id="B2" value="37.2" spread="17.07"/>
                    <measurement group_id="B3" value="37.8" spread="17.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Evaluator's Global Severity Score (EGSS)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Clear</title>
              <category_list>
                <category>
                  <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>
              <title>Almost Clear</title>
              <category_list>
                <category>
                  <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>
              <title>Mild</title>
              <category_list>
                <category>
                  <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>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Severe</title>
              <category_list>
                <category>
                  <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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in Inflammatory Lesion Count</title>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACYC</title>
            <description>ACYC active, topically applied to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ACYC Vehicle</title>
            <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Inflammatory Lesion Count</title>
          <units>Lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="9.75"/>
                    <measurement group_id="O2" value="8.2" spread="11.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in Non-inflammatory Lesion Count</title>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACYC</title>
            <description>ACYC active, topically applied to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ACYC Vehicle</title>
            <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Non-inflammatory Lesion Count</title>
          <units>lesion count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="16.18"/>
                    <measurement group_id="O2" value="9.6" spread="17.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Subjects Who Have a Least a 2 Grade Reduction</title>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACYC</title>
            <description>ACYC active, topically applied to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ACYC Vehicle</title>
            <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects Who Have a Least a 2 Grade Reduction</title>
          <units>Percent with &gt;2% reduction</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear</title>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ACYC</title>
            <description>ACYC active, topically applied to the face for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ACYC Vehicle</title>
            <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear</title>
          <units>percentage of clear or almost clear</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5"/>
                    <measurement group_id="O2" value="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>ACYC</title>
          <description>ACYC active, topically applied to the face for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>ACYC Vehicle</title>
          <description>ACYC vehicle (placebo), topically applied to the face for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="236"/>
              </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 NOT 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>Johnson Varughese</name_or_title>
      <organization>Exec Dir Clinical Dir</organization>
      <phone>908-927-1162</phone>
      <email>johnson.varughese@valeant.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/NCT01701024
org study id: V01-ACYC-301
nct id: NCT01701024
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of this study is to compare the efficacy and safety and tolerability of
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.
The primary objective of this study is to compare the efficacy and safety and tolerability of
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Absolute Change in Inflammatory Lesion Count
time frame: Baseline and 12 Weeks
measure: Absolute Change in Non-inflammatory Lesion Count
time frame: Baseline and 12 Weeks
measure: Percent of Subjects Who Have a Least a 2 Grade Reduction
time frame: Baseline and 12 Weeks
measure: Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
time frame: Baseline and 12 Weeks
arm group label: ACYC
arm group type: Active Comparator
description: ACYC active, topically applied to the face for 12 weeks
arm group label: ACYC vehicle
arm group type: Placebo Comparator
description: ACYC vehicle (placebo), topically applied to the face for 12 weeks
intervention type: Drug
intervention name: ACYC
description: ACYC active, topically applied to the face for 12 weeks
arm group label: ACYC
intervention type: Drug
intervention name: ACYC vehicle
description: ACYC vehicle (placebo), topically applied to the face for 12 weeks
arm group label: ACYC vehicle
criteria: 
gender: All
minimum age: 12 Years
maximum age: 40 Years
healthy volunteers: No
last name: Nilima Justice, M.D.
role: Study Director
affiliation: Medical Monitor, Valeant Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 