<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/NCT03014635</url>
  </required_header>
  <id_info>
    <org_study_id>1620302</org_study_id>
    <nct_id>NCT03014635</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-2)</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to&#xD;
      severe frown lines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">November 3, 2017</completion_date>
  <primary_completion_date type="Actual">November 3, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales</measure>
    <time_frame>Week 4</time_frame>
    <description>Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group</measure>
    <time_frame>0-36 weeks</time_frame>
    <description>The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group</measure>
    <time_frame>0-36 weeks</time_frame>
    <description>The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">306</enrollment>
  <condition>Glabellar Frown Lines</condition>
  <arm_group>
    <arm_group_label>DaxibotulinumtoxinA 40 units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Biological/Vaccine: Placebos Intramuscular injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Botulinum Toxins, Type A</intervention_name>
    <description>Intramuscular injection</description>
    <arm_group_label>DaxibotulinumtoxinA 40 units</arm_group_label>
    <other_name>DaxibotulinumtoxinA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Intramuscular injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent including authorization to release health information&#xD;
&#xD;
          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the&#xD;
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale&#xD;
&#xD;
          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient&#xD;
             Frown Wrinkle Severity (PFWS) scale&#xD;
&#xD;
          -  Willing and able to follow all trial procedures, attend all scheduled visits, and&#xD;
             successfully complete the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any neurological condition that may place the subject at increased risk with exposure&#xD;
             to botulinum toxin type A, including peripheral motor neuropathic diseases such as&#xD;
             amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional&#xD;
             disorders such as Lambert-Eaton syndrome and myasthenia gravis&#xD;
&#xD;
          -  Active skin disease, infections or inflammation at the injection sites&#xD;
&#xD;
          -  Plan to receive botulinum toxin type A anywhere in the face through the duration of&#xD;
             the study&#xD;
&#xD;
          -  History of allergy or sensitivity to any botulinum toxin preparations or to any&#xD;
             component of the test article&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device trial or participation in such&#xD;
             a trial within the last 30 days prior to screening through end of trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Islip</city>
        <state>New York</state>
        <zip>11795</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7N 3N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5R 3N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woodbridge</city>
        <state>Ontario</state>
        <zip>L4L 8E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3Z 1B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>February 15, 2022</results_first_submitted>
  <results_first_submitted_qc>June 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2022</results_first_posted>
  <disposition_first_submitted>September 13, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>September 20, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 4, 2019</disposition_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glabellar lines, frown lines</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>November 7, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03014635/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>November 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03014635/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Outpatient, male or non-pregnant, non-nursing females, 18-75 years of age, and in good general health with moderate (2) or severe (3) glabellar lines during maximum frown based on the IGA-FWS and PFWS</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DaxibotulinumtoxinA 40 Units</title>
          <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular injection</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Biological/Vaccine: Placebo Intramuscular injection&#xD;
Placebo: Intramuscular injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="191"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat population</population>
      <group_list>
        <group group_id="B1">
          <title>DaxibotulinumtoxinA 40 Units</title>
          <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular injection</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Biological/Vaccine: Placebo Intramuscular injection&#xD;
Placebo: Intramuscular injection</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="204"/>
            <count group_id="B2" value="102"/>
            <count group_id="B3" value="306"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="283"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.6" lower_limit="21" upper_limit="73"/>
                    <measurement group_id="B2" value="50.5" lower_limit="27" upper_limit="75"/>
                    <measurement group_id="B3" value="49.9" lower_limit="21" upper_limit="75"/>
                  </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="183"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="270"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="36"/>
                  </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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="272"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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>North America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="204"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales</title>
        <description>Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments</description>
        <time_frame>Week 4</time_frame>
        <population>Intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>DaxibotulinumtoxinA 40 Units</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Biological/Vaccine: Placebo Intramuscular injection&#xD;
Placebo: Intramuscular injection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales</title>
          <description>Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments</description>
          <population>Intent to treat population</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group</title>
        <description>The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.</description>
        <time_frame>0-36 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>DaxibotulinumtoxinA 40 Units</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular injection</description>
          </group>
        </group_list>
        <measure>
          <title>The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group</title>
          <description>The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.</description>
          <population>ITT population</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167" lower_limit="142" upper_limit="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group</title>
        <description>The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.</description>
        <time_frame>0-36 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>DaxibotulinumtoxinA 40 Units</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular injection</description>
          </group>
        </group_list>
        <measure>
          <title>The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group</title>
          <description>The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.</description>
          <population>ITT population</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182" lower_limit="169" upper_limit="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected throughout the entire study, up to 36 weeks</time_frame>
      <desc>Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.</desc>
      <group_list>
        <group group_id="E1">
          <title>DaxibotulinumtoxinA 40 Units</title>
          <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular injection</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Biological/Vaccine: Placebo Intramuscular injection&#xD;
Placebo: Intramuscular injection</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="205"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="205"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Uterine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Leiomyosarcoma recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Uterine leiomyosarcoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </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="30" subjects_at_risk="205"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="205"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="21" subjects_affected="18" subjects_at_risk="205"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </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>With respect to any proposed publication or disclosure of the results of the Study, the Study Center and Investigator shall submit to Revance a copy of the proposed publication or disclosure 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, and (ii) to identify any Confidential Information to be deleted from the proposed publication or disclosure.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Todd Gross, PhD, VP Data Science, Interim Head of Clinical Development</name_or_title>
      <organization>Revance Therapeutics, Inc.</organization>
      <phone>510-742-3400</phone>
      <email>tgross@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/NCT03014635
org study id: 1620302
nct id: NCT03014635
lead sponsor: 
has dmc: No
This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to
      severe frown lines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
time frame: Week 4
description: Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
measure: The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
time frame: 0-36 weeks
description: The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
measure: The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
time frame: 0-36 weeks
description: The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
arm group label: DaxibotulinumtoxinA 40 units
arm group type: Experimental
description: Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Biological/Vaccine: Placebos Intramuscular injection
intervention type: Biological
intervention name: Botulinum Toxins, Type A
description: Intramuscular injection
arm group label: DaxibotulinumtoxinA 40 units
other name: DaxibotulinumtoxinA
intervention type: Biological
intervention name: Placebos
description: Intramuscular injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 