A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants
Public ClinicalTrials.gov record NCT06399718. 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 a BOTOX injection 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
- NCT06399718
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 207 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 30, 2024 (Actual)
- Primary completion
- Nov 10, 2025 (Actual)
- Completion
- Nov 10, 2025 (Actual)
- Last update posted
- Aug 12, 2026
2024 – 2025
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Westside Aesthetics /ID# 248232 | Los Angeles | California | 90025-1708 | — |
| Private Practice - Dr. Steven G. Yoelin /ID# 268046 | Newport Beach | California | 92663 | — |
| Pacific Clinical Innovations /ID# 248231 | Vista | California | 92083-6030 | — |
| Sherber + RAD /ID# 248894 | Washington D.C. | District of Columbia | 20005-5002 | — |
| Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478 | Boca Raton | Florida | 33431-6465 | — |
| Skin Research Institute LLC /ID# 248230 | Coral Gables | Florida | 33146-1837 | — |
| Kavali Plastic Surgery and Skin Renewal Center /ID# 248480 | Atlanta | Georgia | 30328 | — |
| DeNova Research /ID# 248237 | Chicago | Illinois | 60610 | — |
| DelRicht Research /ID# 250313 | Baton Rouge | Louisiana | 70809 | — |
| Etre Cosmetic Dermatology and Laser Center /ID# 248229 | New Orleans | Louisiana | 70130-4353 | — |
| Aesthetic Center at Woodholme /ID# 248481 | Baltimore | Maryland | 21208-6391 | — |
| Michigan Center for Research Corporation /ID# 249145 | Clinton Township | Michigan | 48038 | — |
| Skin Specialists /ID# 248233 | Omaha | Nebraska | 68144 | — |
| Laser & Skin Surgery Center of New York /ID# 248479 | New York | New York | 10016-4974 | — |
| Luxurgery /ID# 248236 | New York | New York | 10021 | — |
| The Practice of Brian S. Biesman MD PLLC /ID# 248226 | Nashville | Tennessee | 37203 | — |
| Sherman Aesthetic Center /ID# 248482 | Nashville | Tennessee | 37205-2205 | — |
| Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875 | Austin | Texas | 78746-4720 | — |
| DermResearch Inc. /ID# 248227 | Austin | Texas | 78759 | — |
| Austin Institute for Clinical Research at SBA Dermatology /ID# 248228 | Houston | Texas | 77056-4129 | — |
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 NCT06399718, 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 12, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06399718 live on ClinicalTrials.gov.