<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/NCT02189629</url>
  </required_header>
  <id_info>
    <org_study_id>RD.06.SPR.18250</org_study_id>
    <nct_id>NCT02189629</nct_id>
  </id_info>
  <brief_title>CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris</brief_title>
  <official_title>A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of&#xD;
      treatment on the face and trunk for acne vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term&#xD;
      treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a&#xD;
      secondary objective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2015</start_date>
  <completion_date type="Actual">February 23, 2017</completion_date>
  <primary_completion_date type="Actual">February 23, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator Global Assessment (IGA) Success Rate up to Week 52</measure>
    <time_frame>From Baseline to Week 52</time_frame>
    <description>Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment (PGA) Success Rate up to Week 52</measure>
    <time_frame>From Baseline to Week 52</time_frame>
    <description>Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">453</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>CD5789 (trifarotene) cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CD5789 (trifarotene)</intervention_name>
    <arm_group_label>CD5789 (trifarotene) cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening&#xD;
             and Baseline visits.&#xD;
&#xD;
          -  The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions&#xD;
             at Screening and Baseline visits on the face.&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary&#xD;
             acne form (chloracne, drug-induced acne, etc.).&#xD;
&#xD;
          -  The Subject has more than 1 nodule on the face at Screening and at Baseline visits.&#xD;
&#xD;
          -  The Subject has any acne cyst on the face at Screening and at Baseline visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Chan</last_name>
    <role>Study Director</role>
    <affiliation>Galderma R&amp;D</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Chomutov</city>
        <zip>430 04</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Olomouc</city>
        <zip>775 20</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pardubice</city>
        <zip>532 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational site</name>
      <address>
        <city>Praha 1</city>
        <zip>110 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Augsburg</city>
        <zip>86179</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>13507</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Dessau</city>
        <zip>06847</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Mahlow</city>
        <zip>15831</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Wuppertal</city>
        <zip>42287</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Miskolc</city>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pécel</city>
        <zip>2119</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <results_first_submitted>April 18, 2019</results_first_submitted>
  <results_first_submitted_qc>August 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2019</results_first_posted>
  <disposition_first_submitted>May 15, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>May 17, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 18, 2018</disposition_first_posted>
  <last_update_submitted>November 12, 2019</last_update_submitted>
  <last_update_submitted_qc>November 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acne vulgaris</keyword>
  <keyword>Safety</keyword>
  <keyword>Face</keyword>
  <keyword>Trunk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trifarotene</mesh_term>
  </intervention_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>August 7, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT02189629/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>August 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT02189629/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CD5789 Cream</title>
          <description>CD5789 Trifarotene 50 microgram/gram cream</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="453"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="348"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 455 subjects were enrolled and 453 were exposed to CD5789 50 microgram/gram cream for up to 52 weeks.</population>
      <group_list>
        <group group_id="B1">
          <title>CD5789 Cream</title>
          <description>CD5789 Trifarotene 50 microgram/gram</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="453"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="286"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="227"/>
                  </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="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="406"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="432"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Investigator Global Assessment (IGA) Success Rate up to Week 52</title>
        <description>Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).</description>
        <time_frame>From Baseline to Week 52</time_frame>
        <population>A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram.</population>
        <group_list>
          <group group_id="O1">
            <title>CD5789 Cream</title>
            <description>CD5789 Trifarotene 50 microgram/gram</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Global Assessment (IGA) Success Rate up to Week 52</title>
          <description>Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).</description>
          <population>A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram.</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="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Global Assessment (PGA) Success Rate up to Week 52</title>
        <description>Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).</description>
        <time_frame>From Baseline to Week 52</time_frame>
        <population>A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram</population>
        <group_list>
          <group group_id="O1">
            <title>CD5789 Cream</title>
            <description>CD5789 Trifarotene 50 microgram/gram</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Global Assessment (PGA) Success Rate up to Week 52</title>
          <description>Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).</description>
          <population>A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram</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="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over 52 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CD5789 Cream</title>
          <description>CD5789 Trifarotene 50 microgram/gram</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="453"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Crohn's Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Pyelonephritis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Complex partial seizures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Complex regional Pain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="170" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application Site Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Application Site Irritation</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Infectious Mononucleosis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="453"/>
              </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>All data or results arising out of the study will not be presented or published in any form or media by the PI/Institution without the prior written consent of sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anne Fulton</name_or_title>
      <organization>Galderma S.A.</organization>
      <phone>+1 817-961-5203</phone>
      <email>anne.fulton@galderma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189629
org study id: RD.06.SPR.18250
nct id: NCT02189629
lead sponsor: 
has dmc: No
Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of
      treatment on the face and trunk for acne vulgaris.
To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term
      treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a
      secondary objective.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigator Global Assessment (IGA) Success Rate up to Week 52
time frame: From Baseline to Week 52
description: Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).
measure: Physician Global Assessment (PGA) Success Rate up to Week 52
time frame: From Baseline to Week 52
description: Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).
arm group label: CD5789 (trifarotene) cream
arm group type: Experimental
intervention type: Drug
intervention name: CD5789 (trifarotene)
arm group label: CD5789 (trifarotene) cream
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Chan
role: Study Director
affiliation: Galderma R&D
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country: Czechia
country: Germany
country: Hungary
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Trifarotene
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