<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/NCT03786770</url>
  </required_header>
  <id_info>
    <org_study_id>1820202</org_study_id>
    <nct_id>NCT03786770</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)</brief_title>
  <official_title>A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for the Treatment of Dynamic Forehead Lines (Frontalis) Following Glabellar Line Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revance Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Revance Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of&#xD;
      moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of&#xD;
      the glabellar complex.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation</measure>
    <time_frame>Week 4 After FHL Treatment</time_frame>
    <description>Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Frown Lines</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: Dose C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: Dose D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DaxibotulinumtoxinA for injection</intervention_name>
    <description>Intramuscular injection</description>
    <arm_group_label>Cohort 1: Dose A</arm_group_label>
    <arm_group_label>Cohort 2: Dose B</arm_group_label>
    <arm_group_label>Cohort 3: Dose C</arm_group_label>
    <arm_group_label>Cohort 4: Dose D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent consistent with International Conference on&#xD;
             Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local laws, including&#xD;
             authorization to release health information, signed prior to any study procedures&#xD;
             being performed&#xD;
&#xD;
          -  Be outpatient, male or female subjects, in good general health, 18-65 years of age&#xD;
&#xD;
          -  Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow&#xD;
             elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity&#xD;
             (IGA-FHWS)&#xD;
&#xD;
          -  Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow&#xD;
             elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS)&#xD;
&#xD;
          -  Have a score of moderate (2) or severe (3) GL during maximum frown based on the&#xD;
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale&#xD;
&#xD;
          -  Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by&#xD;
             the Patient Frown Wrinkle Severity (PFWS)&#xD;
&#xD;
          -  Be willing to refrain from receiving facial fillers, laser treatments, use of any&#xD;
             product that affects skin remodeling, or a product that may cause an active dermal&#xD;
             response in the treatment areas (e.g., above the inferior orbital rim) from screening&#xD;
             through the end of the study&#xD;
&#xD;
          -  Able to understand the requirements of the study and be willing and able to follow all&#xD;
             study procedures, attend all scheduled visits, and successfully complete the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active skin disease, infections, or inflammation at the injection sites&#xD;
&#xD;
          -  Plans to receive botulinum toxin type A anywhere in the face (other than study&#xD;
             treatment) from screening through the end of the study&#xD;
&#xD;
          -  History of clinically significant bleeding disorders&#xD;
&#xD;
          -  Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium&#xD;
             depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment&#xD;
             areas within 3 months before enrollment through the end of the study&#xD;
&#xD;
          -  Clinically significant laboratory values at screening that may interfere with a&#xD;
             subject's ability to complete the study as determined by the investigator&#xD;
&#xD;
          -  History of upper or lower lid blepharoplasty or brow lift&#xD;
&#xD;
          -  Prior periorbital or forehead surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boca Raton site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coral Gables site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto, Ontario site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5R3N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodbridge, Ontario site</name>
      <address>
        <city>Woodbridge</city>
        <state>Ontario</state>
        <zip>L4L8E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>January 18, 2023</results_first_submitted>
  <results_first_submitted_qc>January 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2023</results_first_posted>
  <disposition_first_submitted>February 11, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>February 11, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 12, 2021</disposition_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Forehead Lines</keyword>
  <keyword>Glabellar Lines</keyword>
  <keyword>Frown Lines</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</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>March 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03786770/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>April 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03786770/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: DAXI 40 U GL / 12 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: DAXI 40 U GL / 18 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3: DAXI 40 U GL / 24 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4: DAXI 40 U GL / 30 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat population</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: DAXI 40 U GL / 12 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: DAXI 40 U GL / 18 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3: DAXI 40 U GL / 24 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="B4">
          <title>Cohort 4: DAXI 40 U GL / 30 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U</description>
        </group>
        <group group_id="B5">
          <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="14"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="61"/>
          </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" lower_limit="37" upper_limit="62"/>
                    <measurement group_id="B2" value="48.1" lower_limit="34" upper_limit="60"/>
                    <measurement group_id="B3" value="47.8" lower_limit="26" upper_limit="62"/>
                    <measurement group_id="B4" value="45.6" lower_limit="28" upper_limit="65"/>
                    <measurement group_id="B5" value="47.6" lower_limit="26" upper_limit="65"/>
                  </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="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation</title>
        <description>Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.</description>
        <time_frame>Week 4 After FHL Treatment</time_frame>
        <population>The FHL-evaluable population</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: DAXI 40 U GL / 12 U FHL</title>
            <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: DAXI 40 U GL / 18 U FHL</title>
            <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: DAXI 40 U GL / 24 U FHL</title>
            <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: DAXI 40 U GL / 30 U FHL</title>
            <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation</title>
          <description>Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.</description>
          <population>The FHL-evaluable population</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                    <measurement group_id="O2" value="86.7"/>
                    <measurement group_id="O3" value="93.8"/>
                    <measurement group_id="O4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse events were collected throughout the entire study, up to 36 weeks after FHL treatment (total of 38 weeks).</time_frame>
      <desc>The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: DAXI 40 U GL / 12 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: DAXI 40 U GL / 18 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3: DAXI 40 U GL / 24 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 4: DAXI 40 U GL / 30 U FHL</title>
          <description>DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U.</description>
        </group>
      </group_list>
      <serious_events>
        <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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="5" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Eyelid ptosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </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>The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Domenico Vitarella, Sr. Director, Clinical Development</name_or_title>
      <organization>Revance Therapeutics, Inc.</organization>
      <phone>510-742-3400</phone>
      <email>dvitarella@revance.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/NCT03786770
org study id: 1820202
nct id: NCT03786770
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of
      moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of
      the glabellar complex.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
time frame: Week 4 After FHL Treatment
description: Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.
arm group label: Cohort 1: Dose A
arm group type: Experimental
description: DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
arm group label: Cohort 2: Dose B
arm group type: Experimental
description: DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
arm group label: Cohort 3: Dose C
arm group type: Experimental
description: DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
arm group label: Cohort 4: Dose D
arm group type: Experimental
description: DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
intervention type: Biological
intervention name: DaxibotulinumtoxinA for injection
description: Intramuscular injection
arm group label: Cohort 1: Dose A
arm group label: Cohort 2: Dose B
arm group label: Cohort 3: Dose C
arm group label: Cohort 4: Dose D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 