<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/NCT02248844</url>
  </required_header>
  <id_info>
    <org_study_id>191622-147</org_study_id>
    <nct_id>NCT02248844</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea</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 is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness&#xD;
      of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous&#xD;
      glabellar lines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2014</start_date>
  <completion_date type="Actual">August 14, 2017</completion_date>
  <primary_completion_date type="Actual">August 14, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale</measure>
    <time_frame>Baseline, Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale</measure>
    <time_frame>Baseline, Up to 3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">667</enrollment>
  <condition>Lateral Canthal Lines</condition>
  <condition>Crow's Feet Lines</condition>
  <arm_group>
    <arm_group_label>Botulinum Toxin Type A</arm_group_label>
    <description>Subjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Botulinum Toxin Type A</intervention_name>
    <description>Botulinum toxin Type A injected into crow's feet line areas per clinical practice.</description>
    <arm_group_label>Botulinum Toxin Type A</arm_group_label>
    <other_name>BOTOX®</other_name>
    <other_name>onabotulinumtoxinA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with Lateral Canthal Lines (Crow's Feet Lines)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject and Investigator decision to treat crow's feet lines with Botox®&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</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>
      <name>Dr. Robbin Clinic</name>
      <address>
        <city>Gangnam-gu</city>
        <state>Seoul</state>
        <zip>135-839</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02248844
org study id: 191622-147
nct id: NCT02248844
lead sponsor: 
has dmc: No
This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness
      of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous
      glabellar lines.
observational model: Case-Only
time perspective: Prospective
measure: Number of Participants with Adverse Events
time frame: Up to 3 months
measure: Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale
time frame: Baseline, Up to 3 months
measure: Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale
time frame: Baseline, Up to 3 months
arm group label: Botulinum Toxin Type A
description: Subjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice.
intervention type: Biological
intervention name: Botulinum Toxin Type A
description: Botulinum toxin Type A injected into crow's feet line areas per clinical practice.
arm group label: Botulinum Toxin Type A
other name: BOTOX®
other name: onabotulinumtoxinA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: Korea, Republic of
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA