<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/NCT03004248</url>
  </required_header>
  <id_info>
    <org_study_id>1620303</org_study_id>
    <nct_id>NCT03004248</nct_id>
  </id_info>
  <brief_title>Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines</brief_title>
  <official_title>An Open-Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (SAKURA OPEN-LABEL SAFETY)</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 long term safety study of DaxibotulinumtoxinA for Injection for the treatment of&#xD;
      moderate to severe glabellar lines following single and repeat administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 9, 2016</start_date>
  <completion_date type="Actual">October 17, 2018</completion_date>
  <primary_completion_date type="Actual">October 17, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (TEAE)</measure>
    <time_frame>0-36 weeks</time_frame>
    <description>Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.</description>
  </primary_outcome>
  <secondary_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>
  </secondary_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 per cycles 1 and 2</time_frame>
    <description>The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.</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 per Cycle 1 and 2</time_frame>
    <description>The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2691</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>
  <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>
  <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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</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>Manhattan Beach</city>
        <state>California</state>
        <zip>90266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</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>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincolnshire</city>
        <state>Illinois</state>
        <zip>60069</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>New Orleans</city>
        <state>Louisiana</state>
        <zip>70130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glenn Dale</city>
        <state>Maryland</state>
        <zip>20769</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Michigan</state>
        <zip>48009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63122</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>Montclair</city>
        <state>New Jersey</state>
        <zip>07042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</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>White Plains</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</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>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Drexel Hill</city>
        <state>Pennsylvania</state>
        <zip>19026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mequon</city>
        <state>Wisconsin</state>
        <zip>53092</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>M5R3N8</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>Montréal</city>
        <state>Quebec</state>
        <zip>H3Z 1BZ</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>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <results_first_submitted>February 15, 2022</results_first_submitted>
  <results_first_submitted_qc>June 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 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 16, 2022</last_update_submitted>
  <last_update_submitted_qc>June 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 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>March 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03004248/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 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03004248/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 years of age or older, 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_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2691"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received a Single Treatment</title>
              <participants_list>
                <participants group_id="P1" count="1809"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Two Treatments</title>
              <participants_list>
                <participants group_id="P1" count="314"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Three Treatments</title>
              <participants_list>
                <participants group_id="P1" count="568"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2314"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="377"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population consisting of all enrolled subjects.</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_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2691"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="50.0" lower_limit="21" upper_limit="86"/>
                  </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="2383"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="308"/>
                  </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="2407"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black of African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Others</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </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="2691"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Treatment Emergent Adverse Events (TEAE)</title>
        <description>Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.</description>
        <time_frame>0-36 weeks</time_frame>
        <population>Safety Evaluable Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Cycle 1</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
          <group group_id="O2">
            <title>Treatment Cycle 2</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
          <group group_id="O3">
            <title>Treatment Cycle 3</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events (TEAE)</title>
          <description>Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.</description>
          <population>Safety Evaluable Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2380"/>
                <count group_id="O2" value="882"/>
                <count group_id="O3" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="831"/>
                    <measurement group_id="O2" value="267"/>
                    <measurement group_id="O3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</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>Safety Evaluable Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Cycle 1</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
          <group group_id="O2">
            <title>Treatment Cycle 2</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
          <group group_id="O3">
            <title>Treatment Cycle 3</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: 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>Safety Evaluable 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="2380"/>
                <count group_id="O2" value="882"/>
                <count group_id="O3" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2"/>
                    <measurement group_id="O2" value="76.8"/>
                    <measurement group_id="O3" value="76.6"/>
                  </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 time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.</description>
        <time_frame>0-36 weeks per cycles 1 and 2</time_frame>
        <population>Safety Evaluable Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Cycle 1</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
          <group group_id="O2">
            <title>Treatment Cycle 2</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 time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.</description>
          <population>Safety Evaluable 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="2380"/>
                <count group_id="O2" value="882"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.0" lower_limit="167" upper_limit="168"/>
                    <measurement group_id="O2" value="169.0" lower_limit="168" upper_limit="173"/>
                  </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 time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.</description>
        <time_frame>0-36 weeks per Cycle 1 and 2</time_frame>
        <population>Safety Evaluable Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Cycle 1</title>
            <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: Intramuscular Injection</description>
          </group>
          <group group_id="O2">
            <title>Treatment Cycle 2</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 time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.</description>
          <population>Safety Evaluable 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="2380"/>
                <count group_id="O2" value="882"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196" lower_limit="196" upper_limit="197"/>
                    <measurement group_id="O2" value="197" lower_limit="196" upper_limit="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0-54 weeks</time_frame>
      <desc>Does not differ than the Clinicaltrials.gov definition</desc>
      <group_list>
        <group group_id="E1">
          <title>Overall</title>
          <description>Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection&#xD;
Botulinum Toxins, Type A: 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="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Pancreatis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Hodgkin's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Invasive ductal breat carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Metastatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
              <event>
                <sub_title>Parasthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2691"/>
              </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="158" subjects_at_risk="2691"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="183" subjects_affected="158" subjects_at_risk="2691"/>
              </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/NCT03004248
org study id: 1620303
nct id: NCT03004248
lead sponsor: 
has dmc: No
This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of
      moderate to severe glabellar lines following single and repeat administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment Emergent Adverse Events (TEAE)
time frame: 0-36 weeks
description: Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.
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 per cycles 1 and 2
description: The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.
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 per Cycle 1 and 2
description: The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.
arm group label: DaxibotulinumtoxinA 40 units
arm group type: Experimental
description: Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
intervention type: Biological
intervention name: Botulinum Toxins, Type A
description: Intramuscular Injection
arm group label: DaxibotulinumtoxinA 40 units
other name: DaxibotulinumtoxinA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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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
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