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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
292
Intramuscular Injection
Advanced Research Associates - Glendale /ID# 231997
Glendale, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 231990
Scottsdale, Arizona, United States
Clinical Testing of Beverly Hills /ID# 231986
Encino, California, United States
Steve Yoelin MD Medical Assoc. Inc /ID# 232004
Newport Beach, California, United States
Cosmetic Laser Dermatology /ID# 232414
San Diego, California, United States
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
Time frame: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)
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Ava T. Shamban MD - Santa Monica. /ID# 232000
Santa Monica, California, United States
Art of Skin MD /ID# 231995
Solana Beach, California, United States
DMR Research PLLC /ID# 231998
Westport, Connecticut, United States
Susan H. Weinkle MD /ID# 232001
Bradenton, Florida, United States
Research Institute of the Southeast, LLC /ID# 231974
West Palm Beach, Florida, United States
...and 19 more locations