NCT05134649

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

Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Platysma Prominence

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	Intramuscular Injection

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2021-11-26
• Last updated: 2024-12-05
• Results posted: 2024-12-05

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study