NCT04994535

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

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK. Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Participants will attend regular monthly visits during the study at the study site.

Conditions

• Platysma Prominence

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	Injection
DRUG	Placebo	Saline injection

Timeline

• Start date: 2021-08-10
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2021-08-06
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

34 sites across 5 countries: United States, Belgium, Canada, Germany, United Kingdom

Regulatory

• FDA-regulated drug study