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

Study Identifier
M21-309
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language 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 in the United States and Canada.

    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
    Advanced Research Associates - Glendale /ID# 229256
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Clear Dermatology & Aesthetics Center /ID# 229252
    Scottsdale, Arizona, United States, 85255-4134
    Status
    Not applicable
    Location
    Clinical Testing of Beverly Hills /ID# 229946
    Encino, California, United States, 91436-2124
    Status
    Not applicable
    Location
    Dermatology Research Associates /ID# 229949
    Los Angeles, California, United States, 90045
    Status
    Not applicable
    Location
    Steve Yoelin MD Medical Associate Inc /ID# 229420
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 229245
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
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