Trials / Completed
CompletedNCT02010775
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
BOTOX® Treatment of Masseter Muscle Hypertrophy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | botulinum toxin Type A | Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable. |
| DRUG | Normal saline | Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles. |
Timeline
- Start date
- 2014-01-20
- Primary completion
- 2017-03-07
- Completion
- 2017-11-29
- First posted
- 2013-12-13
- Last updated
- 2019-05-28
- Results posted
- 2019-05-28
Locations
14 sites across 3 countries: Australia, Canada, Taiwan
Source: ClinicalTrials.gov record NCT02010775. Inclusion in this directory is not an endorsement.