<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/NCT04451330</url>
  </required_header>
  <id_info>
    <org_study_id>RD.06.SPR.202394</org_study_id>
    <nct_id>NCT04451330</nct_id>
  </id_info>
  <brief_title>A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)</brief_title>
  <acronym>DUAL</acronym>
  <official_title>A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789)&#xD;
      50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and&#xD;
      effective for the treatment of severe AV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">April 26, 2021</completion_date>
  <primary_completion_date type="Actual">April 26, 2021</primary_completion_date>
  <phase>Phase 4</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 From Baseline in Facial Total Lesion Counts to Week 12</measure>
    <time_frame>From Baseline to Week 12</time_frame>
    <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12</measure>
    <time_frame>From Baseline to Week 12</time_frame>
    <description>All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12</measure>
    <time_frame>From Baseline to Week 12</time_frame>
    <description>Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12</measure>
    <time_frame>From Baseline to Week 12</time_frame>
    <description>IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Trifarotene Cream + Doxycycline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trifarotene Vehicle + Doxycycline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trifarotene cream</intervention_name>
    <description>Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.</description>
    <arm_group_label>Trifarotene Cream + Doxycycline</arm_group_label>
    <other_name>AKLIEF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycline hyclate</intervention_name>
    <description>Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.</description>
    <arm_group_label>Trifarotene Cream + Doxycycline</arm_group_label>
    <other_name>DORYX MPC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trifarotene Vehicle</intervention_name>
    <description>Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.</description>
    <arm_group_label>Trifarotene Vehicle + Doxycycline Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycline Placebo</intervention_name>
    <description>Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.</description>
    <arm_group_label>Trifarotene Vehicle + Doxycycline Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4&#xD;
             (Severe)&#xD;
&#xD;
          -  Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to&#xD;
             120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2&#xD;
             nodules (less than [&lt;]1 centimeter [cm] in diameter) on the face, excluding the nose&#xD;
&#xD;
          -  Agrees to provide written informed consent&#xD;
&#xD;
          -  Participant is a female of non-childbearing potential (premenarchal or postmenopausal&#xD;
             [absence of menstrual bleeding for 1 year prior to Screening, without any other&#xD;
             medical reason], hysterectomy or bilateral oophorectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant with any acne cyst on the face&#xD;
&#xD;
          -  Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne&#xD;
             (chloracne, drug-induced acne, etc.)&#xD;
&#xD;
          -  Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion,&#xD;
             eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments&#xD;
             in the opinion of the investigator&#xD;
&#xD;
          -  Participants who is at risk in terms of precautions, warnings, and contraindications&#xD;
             for trifarotene or doxycycline hyclate&#xD;
&#xD;
          -  Currently receiving any prescription testosterone therapy (e.g., testosterone&#xD;
             cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or&#xD;
             on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone&#xD;
             [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate,&#xD;
             testosterone propionate, testosterone phenylpropionate) or testosterone supplements&#xD;
             (e.g., Tribulus).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</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>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</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>30263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>New Brighton</city>
        <state>Minnesota</state>
        <zip>55112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</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>Sugarloaf</city>
        <state>Pennsylvania</state>
        <zip>18249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>71913</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>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Grapevine</city>
        <state>Texas</state>
        <zip>76051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galderma Investigational Site</name>
      <address>
        <city>Aibonito</city>
        <zip>705</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <results_first_submitted>April 20, 2022</results_first_submitted>
  <results_first_submitted_qc>April 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2022</results_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxycycline</mesh_term>
    <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 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04451330/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 6, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04451330/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at United States of America and Puerto Rico between 29 Jul 2020 and 26 Apr 2021.</recruitment_details>
      <pre_assignment_details>A total of 202 participants were randomized in 2:1 ratio in 2 treatment groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Trifarotene (CD5789) Cream + Doxycycline</title>
          <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Trifarotene Vehicle + Doxycycline Placebo</title>
          <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week 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="133"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on Intent to treat (ITT) population that included all participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Trifarotene + Doxycycline</title>
          <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Trifarotene Vehicle + Doxycycline Placebo</title>
          <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week 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="133"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.0" spread="7.30"/>
                    <measurement group_id="B2" value="20.3" spread="8.92"/>
                    <measurement group_id="B3" value="20.1" spread="7.87"/>
                  </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="80"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="79"/>
                  </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="50"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="132"/>
                  </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="3"/>
                    <measurement group_id="B3" value="9"/>
                  </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="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </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>Facial Total Lesions Counts</title>
          <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and noninflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.</description>
          <units>Lesion counts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101.5" spread="40.11"/>
                    <measurement group_id="B2" value="100.7" spread="33.91"/>
                    <measurement group_id="B3" value="101.2" spread="38.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Facial Total Lesion Counts to Week 12</title>
        <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.</description>
        <time_frame>From Baseline to Week 12</time_frame>
        <population>The ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Trifarotene + Doxycycline</title>
            <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Trifarotene Vehicle + Doxycycline Placebo</title>
            <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Facial Total Lesion Counts to Week 12</title>
          <description>Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.</description>
          <population>The ITT population included all participants who were randomized.</population>
          <units>Lesion counts</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-69.1" spread="2.28"/>
                    <measurement group_id="O2" value="-48.1" spread="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12</title>
        <description>All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.</description>
        <time_frame>From Baseline to Week 12</time_frame>
        <population>The ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Trifarotene + Doxycycline</title>
            <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Trifarotene Vehicle + Doxycycline Placebo</title>
            <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12</title>
          <description>All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.</description>
          <population>The ITT population included all participants who were randomized.</population>
          <units>Lesion counts</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.4" spread="1.09"/>
                    <measurement group_id="O2" value="-19.5" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12</title>
        <description>Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.</description>
        <time_frame>From Baseline to Week 12</time_frame>
        <population>The ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Trifarotene + Doxycycline</title>
            <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Trifarotene Vehicle + Doxycycline Placebo</title>
            <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12</title>
          <description>Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.</description>
          <population>The ITT population included all participants who were randomized.</population>
          <units>Lesion counts</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.5" spread="1.42"/>
                    <measurement group_id="O2" value="-28.2" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12</title>
        <description>IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.</description>
        <time_frame>From Baseline to Week 12</time_frame>
        <population>The ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Trifarotene + Doxycycline</title>
            <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Trifarotene Vehicle + Doxycycline Placebo</title>
            <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12</title>
          <description>IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.</description>
          <population>The ITT population included all participants who were randomized.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7"/>
                    <measurement group_id="O2" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline up to Week 12.</time_frame>
      <desc>Analysis was performed on safety population which comprised of all randomized participants who applied/took the study drug at least once.</desc>
      <group_list>
        <group group_id="E1">
          <title>Trifarotene + Doxycycline</title>
          <description>Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Trifarotene Vehicle + Doxycycline Placebo</title>
          <description>Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 23</default_vocab>
        <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="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Self-Injurious Ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="133"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="133"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations</name_or_title>
      <organization>Galderma</organization>
      <phone>817 961 5000 ext 1</phone>
      <email>Clinical.Studies@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/NCT04451330
org study id: RD.06.SPR.202394
nct id: NCT04451330
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789)
      50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and
      effective for the treatment of severe AV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
time frame: From Baseline to Week 12
description: Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
measure: Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
time frame: From Baseline to Week 12
description: All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
measure: Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
time frame: From Baseline to Week 12
description: Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
measure: Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
time frame: From Baseline to Week 12
description: IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
arm group label: Trifarotene Cream + Doxycycline
arm group type: Experimental
description: Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
arm group label: Trifarotene Vehicle + Doxycycline Placebo
arm group type: Placebo Comparator
description: Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
intervention type: Drug
intervention name: Trifarotene cream
description: Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
arm group label: Trifarotene Cream + Doxycycline
other name: AKLIEF
intervention type: Drug
intervention name: Doxycycline hyclate
description: Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
arm group label: Trifarotene Cream + Doxycycline
other name: DORYX MPC
intervention type: Drug
intervention name: Trifarotene Vehicle
description: Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
arm group label: Trifarotene Vehicle + Doxycycline Placebo
intervention type: Drug
intervention name: Doxycycline Placebo
description: Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
arm group label: Trifarotene Vehicle + Doxycycline Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Doxycycline
mesh term: Trifarotene
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 