A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

Study Identifier
M21-310
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, German, German (Belgium), French (Belgium), Dutch (Belgium)
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
  • Study Drug
  • OnabotulinumtoxinA
  • Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.

    Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.

    Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.

    Participants will attend regular monthly visits during the study at the study site.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Derm Ctr /ID# 249905
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Westside Aesthetics /ID# 231196
    Los Angeles, California, United States, 90025-1708
    Status
    Not applicable
    Location
    Skin Care and Laser Physicians of Beverly Hills /ID# 231194
    Los Angeles, California, United States, 90069
    Status
    Not applicable
    Location
    Moradi MD /ID# 244719
    Vista, California, United States, 92083-6030
    Status
    Not applicable
    Location
    Skin Research Institute LLC /ID# 231195
    Coral Gables, Florida, United States, 33146-1837
    Status
    Not applicable
    Location
    Skin and Cancer Associates, LLP /ID# 231189
    Miami, Florida, United States, 33137-3254
    Status
    Not applicable
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