At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 187 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® Treatment of Masseter Muscle Hypertrophy
In Brief
A Phase 2 clinical trial evaluating botulinum toxin Type A and Normal saline for Masseter Muscle Hypertrophy. Completed, enrolled 187 participants across 14 sites in 3 countries.
Detailed Summary
This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMasseter Muscle Hypertrophy
CountriesAustralia, Canada, Taiwan
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJan 2014
Primary CompletionMar 2017
Study CompletionNov 2017
TodayJul 2026
First PostedDec 13, 2013
Enrollment StartJan 20, 2014
Primary CompletionMar 7, 2017
Study CompletionNov 29, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.6 years ago
Interventions
botulinum toxin Type Abiological
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Normal salinedrug
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.