<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/NCT02236312</url>
  </required_header>
  <id_info>
    <org_study_id>43QM1313</org_study_id>
    <nct_id>NCT02236312</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines</brief_title>
  <official_title>A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a&#xD;
      single treatment of three different doses of botulinum toxin compared to placebo, in the&#xD;
      treatment of moderate to very severe glabellar frown lines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin</measure>
    <time_frame>14 Days</time_frame>
    <description>Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">359</enrollment>
  <condition>Glabellar Frown Lines</condition>
  <arm_group>
    <arm_group_label>Botulinum Toxin 30 units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I.M. injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin 45 units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I.M. injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin 60 units</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I.M. injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>I.M. injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A</intervention_name>
    <arm_group_label>Botulinum Toxin 30 units</arm_group_label>
    <arm_group_label>Botulinum Toxin 45 units</arm_group_label>
    <arm_group_label>Botulinum Toxin 60 units</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject&#xD;
             and the Investigator and at least Mild glabellar lines at rest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous treatment with any botulinum toxin&#xD;
&#xD;
          -  Rhytids of the glabellar region that cannot be smoothed out by manually spreading the&#xD;
             skin apart&#xD;
&#xD;
          -  Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or&#xD;
             collagen fillers to the glabellar region&#xD;
&#xD;
          -  Any history of facial surgery above the lower orbital rim&#xD;
&#xD;
          -  Any planned facial surgery or aesthetic procedure during the study period&#xD;
&#xD;
          -  Ablative skin resurfacing or chemical peels above the lower orbital rim in the&#xD;
             previous 12 months or during the study period&#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>
      <name>Private practice</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <disposition_first_submitted>May 13, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>May 13, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 2, 2016</disposition_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</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, but a results disposition has been submitted           -->
</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/NCT02236312
org study id: 43QM1313
nct id: NCT02236312
lead sponsor: 
has dmc: Yes
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a
      single treatment of three different doses of botulinum toxin compared to placebo, in the
      treatment of moderate to very severe glabellar frown lines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
time frame: 14 Days
description: Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.
arm group label: Botulinum Toxin 30 units
arm group type: Experimental
description: I.M. injection
arm group label: Botulinum Toxin 45 units
arm group type: Experimental
description: I.M. injection
arm group label: Botulinum Toxin 60 units
arm group type: Experimental
description: I.M. injection
arm group label: Placebo
arm group type: Placebo Comparator
description: I.M. injection
intervention type: Drug
intervention name: Botulinum Toxin Type A
arm group label: Botulinum Toxin 30 units
arm group label: Botulinum Toxin 45 units
arm group label: Botulinum Toxin 60 units
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA