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

Completed · Phase 3

Conditions studied: Platysma Prominence

In brief

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.

Key facts

Study ID

NCT05134649

Run by

AbbVie

People needed

292

Starts

2021-11-16

Expected to finish

2023-08-18

Last updated by the study team

2024-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Laser and Skin Surgery Center of Indiana /ID# 231983 — Indianapolis, Indiana, United States
• Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977 — Metairie, Louisiana, United States
• Delricht Research /ID# 231985 — New Orleans, Louisiana, United States
• Aesthetic Center at Woodholme /ID# 231996 — Baltimore, Maryland, 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
• Laser & Skin Surgery Center of New York /ID# 231982 — New York, New York, 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
• KGL Skin Study Center, LLC /ID# 231993 — Newtown Square, Pennsylvania, United States
• Nashville Center for Laser and Facial Surgery /ID# 231975 — Nashville, Tennessee, United States
• Dallas Plastic Surgery Institute /ID# 231999 — Dallas, Texas, United States
• SkinDC /ID# 231989 — Arlington, Virginia, United States
• Premier Clinical Research /ID# 232003 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.