<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/NCT01688076</url>
  </required_header>
  <id_info>
    <org_study_id>STU56722</org_study_id>
    <nct_id>NCT01688076</nct_id>
  </id_info>
  <brief_title>Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection</brief_title>
  <official_title>Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cross-over design study will evaluate the onset of action, efficacy, and duration of&#xD;
      botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without&#xD;
      subsequent muscle contraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this cross-over design study, the investigators will evaluate whether active muscle&#xD;
      contraction following Botox® injection of the forehead/glabellar rhytid complex will impact&#xD;
      the onset of action, efficacy, and duration of Botox® treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale</measure>
    <time_frame>13 months</time_frame>
    <description>A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>13 months</time_frame>
    <description>Side effects and adverse events will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Satisfaction</measure>
    <time_frame>7 months</time_frame>
    <description>Patients will be asked to rate their satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Forehead Rhytid Complex</condition>
  <condition>Glabellar Rhytid Complex</condition>
  <arm_group>
    <arm_group_label>Muscle contractions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No muscle contractions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be asked to not perform muscle contractions following Botox injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Botulinum Toxin A</intervention_name>
    <description>Forehead will be injected with Botox.</description>
    <arm_group_label>Muscle contractions</arm_group_label>
    <arm_group_label>No muscle contractions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In good health&#xD;
&#xD;
          -  Is 18-65 years of age&#xD;
&#xD;
          -  Has static and dynamic forehead/glabellar wrinkles&#xD;
&#xD;
          -  Has decided to receive Botox® treatment for their forehead/glabellar wrinkles&#xD;
&#xD;
          -  Has the willingness and ability to understand and provide informed consent and&#xD;
             communicate with the investigator&#xD;
&#xD;
          -  Is willing to return for follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Has received the following treatments in the forehead or glabellar region:&#xD;
&#xD;
               -  botulinum toxin injections in the past 6 months&#xD;
&#xD;
               -  ablative laser procedure in the past 6 months&#xD;
&#xD;
               -  radiofrequency device treatment in the past 6 months&#xD;
&#xD;
               -  ultrasound device treatment in the past 6 months&#xD;
&#xD;
               -  medium to deep chemical peel in the past 6 months&#xD;
&#xD;
               -  temporary soft tissue augmentation material in the past year&#xD;
&#xD;
               -  semi-permanent soft tissue augmentation material in the past 2 years&#xD;
&#xD;
               -  permanent soft tissue augmentation material&#xD;
&#xD;
          -  Is planning to receive within the next year, any cosmetic procedure (such as any&#xD;
             chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures,&#xD;
             filler injections, radiofrequency procedures, dermabrasion, ultrasound and face&#xD;
             lifting procedures) in the forehead or glabellar region.&#xD;
&#xD;
          -  Is planning to use tretinoin or retinoic acid in the next year&#xD;
&#xD;
          -  Has an active infection in the forehead or glabellar region (excluding mild acne)&#xD;
&#xD;
          -  Is allergic to cow's-milk protein&#xD;
&#xD;
          -  Is allergic to albumin&#xD;
&#xD;
          -  Taking aminoglycoside&#xD;
&#xD;
          -  Is currently using anticoagulation therapy&#xD;
&#xD;
          -  Has a history of bleeding disorders&#xD;
&#xD;
          -  Is unable to understand the protocol or to give informed consent&#xD;
&#xD;
          -  Is unable to return for follow-up visits&#xD;
&#xD;
          -  Has a mental illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine, Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>April 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation</investigator_title>
  </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/NCT01688076
org study id: STU56722
nct id: NCT01688076
lead sponsor: 
has dmc: No
This cross-over design study will evaluate the onset of action, efficacy, and duration of
      botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without
      subsequent muscle contraction.
In this cross-over design study, the investigators will evaluate whether active muscle
      contraction following Botox® injection of the forehead/glabellar rhytid complex will impact
      the onset of action, efficacy, and duration of Botox® treatment.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
time frame: 13 months
description: A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.
measure: Number of Participants with Adverse Events
time frame: 13 months
description: Side effects and adverse events will be assessed
measure: Level of Satisfaction
time frame: 7 months
description: Patients will be asked to rate their satisfaction
arm group label: Muscle contractions
arm group type: Experimental
description: Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.
arm group label: No muscle contractions
arm group type: Active Comparator
description: Patients will be asked to not perform muscle contractions following Botox injections.
intervention type: Procedure
intervention name: Botulinum Toxin A
description: Forehead will be injected with Botox.
arm group label: Muscle contractions
arm group label: No muscle contractions
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA