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BOTOX® (onabotulinumtoxinA) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Total Skin and Beauty Dermatology Center /ID# 248218
Birmingham, Alabama, United States
Mayo Clinic Arizona /ID# 248883
Phoenix, Arizona, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 248223
Los Angeles, California, United States
Cosmetic Laser Dermatology /ID# 248215
San Diego, California, United States
Ava T. Shamban MD - Santa Monica. /ID# 248886
Santa Monica, California, United States
DMR Research PLLC /ID# 248485
Westport, Connecticut, United States
Susan H. Weinkle MD /ID# 252063
Bradenton, Florida, United States
Skin and Cancer Associates, LLP /ID# 248209
Miami, Florida, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827
Metairie, Louisiana, United States
Delricht Research /ID# 249825
New Orleans, Louisiana, United States
Start Date
April 22, 2024
Primary Completion Date
November 25, 2025
Completion Date
November 25, 2025
Last Updated
December 11, 2025
202
ACTUAL participants
BOTOX
DRUG
Placebo
DRUG
Lead Sponsor
AbbVie
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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