A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
Public ClinicalTrials.gov record NCT06387394. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
BOTOX® (onabotulinumtoxinA) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP). BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States. Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
Study identification
- NCT ID
- NCT06387394
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 202 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 21, 2024
- Primary completion
- Nov 24, 2025
- Completion
- Nov 24, 2025
- Last update posted
- Aug 24, 2026
2024 – 2025
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center /ID# 248218 | Birmingham | Alabama | 35205 | — |
| Mayo Clinic Arizona /ID# 248883 | Phoenix | Arizona | 85054 | — |
| Skin Care and Laser Physicians of Beverly Hills /ID# 248223 | Los Angeles | California | 90069 | — |
| Cosmetic Laser Dermatology /ID# 248215 | San Diego | California | 92121-2119 | — |
| Ava T. Shamban MD - Santa Monica. /ID# 248886 | Santa Monica | California | 90404-2208 | — |
| DMR Research PLLC /ID# 248485 | Westport | Connecticut | 06880 | — |
| Susan H. Weinkle MD /ID# 252063 | Bradenton | Florida | 34209-5642 | — |
| Skin and Cancer Associates, LLP /ID# 248209 | Miami | Florida | 33137-3254 | — |
| Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827 | Metairie | Louisiana | 70006 | — |
| Delricht Research /ID# 249825 | New Orleans | Louisiana | 70115 | — |
| Clarkston Dermatology /ID# 248888 | Clarkston | Michigan | 48346 | — |
| Skin Laser and Surgery Specialists of NY and NJ /ID# 251501 | Hackensack | New Jersey | 07601-1997 | — |
| Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 248887 | Latham | New York | 12110 | — |
| Wilmington Dermatology Center /ID# 250651 | Wilmington | North Carolina | 28403 | — |
| Centricity Research Dublin Multispecialty /ID# 248484 | Dublin | Ohio | 43016 | — |
| Tennessee Clinical Research Center /ID# 248486 | Nashville | Tennessee | 37215-2885 | — |
| Bellaire Dermatology Associates /ID# 248221 | Bellaire | Texas | 77401 | — |
| Dallas Plastic Surgery Institute /ID# 248220 | Dallas | Texas | 75231 | — |
| Austin Institute for Clinical Research - Pflugerville /ID# 248217 | Pflugerville | Texas | 78660 | — |
| SkinDC /ID# 248885 | Arlington | Virginia | 22209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06387394, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06387394 live on ClinicalTrials.gov.