A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
- Registration Number
- NCT05134649
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 292
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BOTOX OnabotulinumtoxinA BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Steve Yoelin MD Medical Assoc. Inc /ID# 232004
🇺🇸Newport Beach, California, 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
Aesthetic Center at Woodholme /ID# 231996
🇺🇸Baltimore, Maryland, United States
Humphrey Cosmetic Dermatology /ID# 239649
🇨🇦Vancouver, British Columbia, Canada
Delricht Research /ID# 231985
🇺🇸New Orleans, Louisiana, United States
Advanced Research Associates - Glendale /ID# 231997
🇺🇸Glendale, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 231990
🇺🇸Scottsdale, Arizona, United States
SkinDC /ID# 231989
🇺🇸Arlington, Virginia, United States
Laser & Skin Surgery Center of New York /ID# 231982
🇺🇸New York, New York, United States
Nashville Center for Laser and Facial Surgery /ID# 231975
🇺🇸Nashville, Tennessee, United States
The Center For Dermatology /ID# 239651
🇨🇦Richmond Hill, Ontario, Canada
Clinical Testing of Beverly Hills /ID# 231986
🇺🇸Encino, California, United States
Ava T. Shamban MD - Santa Monica. /ID# 232000
🇺🇸Santa Monica, California, United States
Cosmetic Laser Dermatology /ID# 232414
🇺🇸San Diego, California, United States
Laser and Skin Surgery Center of Indiana /ID# 231983
🇺🇸Indianapolis, Indiana, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002
🇺🇸Hunt Valley, Maryland, United States
Image Dermatology, P.C. /ID# 231980
🇺🇸Montclair, New Jersey, United States
Aesthetic Solutions /ID# 231978
🇺🇸Chapel Hill, North Carolina, United States
Wilmington Dermatology Center /ID# 231981
🇺🇸Wilmington, North Carolina, United States
Aventiv Research Dublin /ID# 231994
🇺🇸Dublin, Ohio, United States
Dallas Plastic Surgery Institute /ID# 231999
🇺🇸Dallas, Texas, United States
Dr Melinda Gooderham Medicine Profession /ID# 239647
🇨🇦Cobourg, Ontario, Canada
KGL Skin Study Center, LLC /ID# 231993
🇺🇸Newtown Square, Pennsylvania, United States
Dermetics Cosmetic Dermatology /ID# 239650
🇨🇦Burlington, Ontario, Canada
Premier Clinical Research /ID# 232003
🇺🇸Spokane, Washington, United States
Art of Skin MD /ID# 231995
🇺🇸Solana Beach, California, United States
DMR Research PLLC /ID# 231998
🇺🇸Westport, Connecticut, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977
🇺🇸Metairie, Louisiana, United States