At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 377 enrolled
Drug / intervention
Botulinum Toxin Type A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
In Brief
A Phase 3 clinical trial evaluating Botulinum Toxin Type A and Placebo for Masseter Muscle Prominence. Completed, enrolled 377 participants across 21 sites in 3 countries.
Detailed Summary
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMasseter Muscle Prominence
CountriesCanada, China, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartAug 2019
Primary CompletionNov 2022
TodayJul 2026
First PostedAug 29, 2019
Enrollment StartAug 29, 2019
Primary CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.8 years ago
Interventions
Botulinum Toxin Type Abiological
Day 1 Administration of bilateral intramuscular injections into the masseter
Placeboother
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter