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

Study Identifier
M21-323
CT.gov Identifier
NCT05134649
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
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Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • OnabotulinumtoxinA
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period \[randomization/treatment with 4-month follow-up visit\] and Study Exit visit)
    Exclusion Criteria:
    * Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention) * Anticipated need for surgery or overnight hospitalization during the study * Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study * Known immunization or hypersensitivity to any botulinum toxin serotype * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months * Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest

    Protocol Summary

    This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study.

    Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.

    Study Locations

    Location
    Status
    Location
    Advanced Research Associates - Glendale /ID# 231997
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Clear Dermatology & Aesthetics Center /ID# 231990
    Scottsdale, Arizona, United States, 85255-4134
    Status
    Not applicable
    Location
    Clinical Testing of Beverly Hills /ID# 231986
    Encino, California, United States, 91436-2124
    Status
    Not applicable
    Location
    Steve Yoelin MD Medical Assoc. Inc /ID# 232004
    Newport Beach, California, United States, 92663-3311
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 232414
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
    Location
    Ava T. Shamban MD - Santa Monica. /ID# 232000
    Santa Monica, California, United States, 90404-2208
    Status
    Not applicable
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