NCT04073303

BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

Conditions

• Masseter Muscle Prominence

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum Toxin Type A	Day 1 Administration of bilateral intramuscular injections into the masseter
OTHER	Placebo	Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter

Timeline

• Start date: 2019-08-29
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2019-08-29
• Last updated: 2025-05-06
• Results posted: 2025-05-06

Locations

21 sites across 3 countries: Canada, China, Taiwan

Regulatory

• FDA-regulated drug study