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NCT03861936 · ClinicalTrials.gov registry record · Phase 2
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence
A Phase 2 study of Masseter Muscle Prominence, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 14
- Study locations
NCT03861936: Completed Phase 2 study of Masseter Muscle Prominence, sponsored by Allergan.
NCT03861936 is a Phase 2 study of Masseter Muscle Prominence that has completed, run by Allergan. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861936, a Phase 2 study of Masseter Muscle Prominence, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Conditions Studied
Interventions
- DRUG Normal saline
- BIOLOGICAL OnabotulinumtoxinA
Study Locations (14)
California
- Westside Aesthetics - Los Angeles
- Skin Care and Laser Physicians of Beverly Hills - Los Angeles
- Cosmetic Laser Dermatology - San Diego
Texas
- DermResearch, Inc. - Austin
- Bellaire Dermatology Associates - Bellaire
- Austin Institute for Clinical Research, Inc. - Pflugerville
Alabama
- Total Skin & Beauty Dermatology Center, PC - Birmingham
Florida
- Baumann Cosmetic and Research Institute - Miami
Illinois
- DeNova Research - Chicago
Louisiana
- Etre, Cosmetic Dermatology and Laser Center - New Orleans
Missouri
- Saint Louis University Dermatology - St Louis
Nebraska
- Skin Specialists, PC - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 2 |
What the finished NCT03861936 record still lists
NCT03861936 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Masseter Muscle Prominence appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT03861936 lists 14 locations in 10 states (California, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT03861936 about?
NCT03861936 is a clinical study titled "BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence". 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.
What is the current status of trial NCT03861936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2019-05-16. Estimated completion is 2020-07-02.
What conditions does trial NCT03861936 study?
This clinical trial studies the following conditions: Masseter Muscle Prominence.
What interventions are being tested in trial NCT03861936?
The interventions under investigation include: Normal saline (DRUG), OnabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT03861936?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03861936 being conducted?
This trial has 14 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03861936's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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