<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/NCT02195687</url>
  </required_header>
  <id_info>
    <org_study_id>191622-113</org_study_id>
    <nct_id>NCT02195687</nct_id>
  </id_info>
  <brief_title>BOTOX® in the Treatment of Crow's Feet Lines in China</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared&#xD;
      with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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 Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)</measure>
    <time_frame>Day 30</time_frame>
    <description>The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A</measure>
    <time_frame>Day 30</time_frame>
    <description>The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A</measure>
    <time_frame>Day 30</time_frame>
    <description>The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)</measure>
    <time_frame>Day 30</time_frame>
    <description>Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire</measure>
    <time_frame>Baseline, Day 30</time_frame>
    <description>Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)</measure>
    <time_frame>Day 30</time_frame>
    <description>The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">417</enrollment>
  <condition>Lateral Canthal Lines</condition>
  <condition>Crow's Feet Lines</condition>
  <arm_group>
    <arm_group_label>botulinum toxin type A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>botulinum toxin Type A</intervention_name>
    <description>botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.</description>
    <arm_group_label>botulinum toxin type A</arm_group_label>
    <other_name>BOTOX®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Moderate to severe Crow's Feet Lines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or previous treatment with botulinum toxin of any serotype for any condition&#xD;
             within the last year&#xD;
&#xD;
          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis&#xD;
&#xD;
          -  Facial laser or light treatment, microdermabrasion or chemical peels within 3 months&#xD;
&#xD;
          -  Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related&#xD;
             procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent&#xD;
             soft tissue fillers within 1 year&#xD;
&#xD;
          -  Any medium-depth or deep facial peels within 5 years&#xD;
&#xD;
          -  Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent&#xD;
             soft tissue fillers, synthetic implants or autologous fat transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>February 17, 2016</results_first_submitted>
  <results_first_submitted_qc>February 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 14, 2016</results_first_posted>
  <last_update_submitted>February 17, 2016</last_update_submitted>
  <last_update_submitted_qc>February 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The participant flow reflects the Safety Population, which includes all randomized subjects who received at least 1 study drug injection.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Botulinum Toxin Type A</title>
          <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="316"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="311"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Botulinum Toxin Type A</title>
          <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</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="316"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="417"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.3" spread="9.64"/>
                    <measurement group_id="B2" value="46.6" spread="9.39"/>
                    <measurement group_id="B3" value="46.4" spread="9.57"/>
                  </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="273"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)</title>
        <description>The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.</description>
        <time_frame>Day 30</time_frame>
        <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A</title>
            <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)</title>
          <description>The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.</description>
          <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</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="316"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.9"/>
                    <measurement group_id="O2" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A</title>
        <description>The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.</description>
        <time_frame>Day 30</time_frame>
        <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A</title>
            <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A</title>
          <description>The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.</description>
          <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</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="316"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.1"/>
                    <measurement group_id="O2" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A</title>
        <description>The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.</description>
        <time_frame>Day 30</time_frame>
        <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A</title>
            <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A</title>
          <description>The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.</description>
          <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</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="316"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.1"/>
                    <measurement group_id="O2" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)</title>
        <description>Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.</description>
        <time_frame>Day 30</time_frame>
        <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A</title>
            <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)</title>
          <description>Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.</description>
          <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</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="316"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire</title>
        <description>Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.</description>
        <time_frame>Baseline, Day 30</time_frame>
        <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A</title>
            <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire</title>
          <description>Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.</description>
          <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline</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="297"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.9"/>
                    <measurement group_id="O2" value="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)</title>
        <description>The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.</description>
        <time_frame>Day 30</time_frame>
        <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A</title>
            <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)</title>
          <description>The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.</description>
          <population>Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug</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="316"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.8"/>
                    <measurement group_id="O2" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The Safety Population included all randomized subjects who received at least 1 study drug injection. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).</desc>
      <group_list>
        <group group_id="E1">
          <title>Botulinum Toxin Type A</title>
          <description>24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="316"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="316"/>
                <counts group_id="E2" subjects_affected="0" 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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head,</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT02195687
org study id: 191622-113
nct id: NCT02195687
lead sponsor: 
has dmc: No
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared
      with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
time frame: Day 30
description: The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
measure: Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
time frame: Day 30
description: The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.
measure: Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
time frame: Day 30
description: The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.
measure: Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
time frame: Day 30
description: Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.
measure: Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
time frame: Baseline, Day 30
description: Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.
measure: Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
time frame: Day 30
description: The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
arm group label: botulinum toxin type A
arm group type: Experimental
description: 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
intervention type: Biological
intervention name: botulinum toxin Type A
description: botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.
arm group label: botulinum toxin type A
other name: BOTOX®
intervention type: Drug
intervention name: Normal Saline
description: Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: China
responsible party type: Sponsor
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 