Trials / Completed
CompletedNCT03861936
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Based on the results of the Phase 2 Study 191622-130 \[NCT02010775\], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OnabotulinumtoxinA | OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1. |
| DRUG | Normal saline | Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1. |
Timeline
- Start date
- 2019-05-16
- Primary completion
- 2020-04-03
- Completion
- 2020-07-02
- First posted
- 2019-03-05
- Last updated
- 2021-04-28
- Results posted
- 2021-04-28
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03861936. Inclusion in this directory is not an endorsement.