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.
Masseter Muscle Prominence
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.
A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
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Total Skin and Beauty Dermatology Center /ID# 248218, Birmingham, Alabama, United States, 35205
Mayo Clinic Arizona /ID# 248883, Phoenix, Arizona, United States, 85054
Skin Care and Laser Physicians of Beverly Hills /ID# 248223, Los Angeles, California, United States, 90069
Cosmetic Laser Dermatology /ID# 248215, San Diego, California, United States, 92121-2119
Ava T. Shamban MD - Santa Monica. /ID# 248886, Santa Monica, California, United States, 90404-2208
DMR Research PLLC /ID# 248485, Westport, Connecticut, United States, 06880
Susan H. Weinkle MD /ID# 252063, Bradenton, Florida, United States, 34209-5642
Skin and Cancer Associates, LLP /ID# 248209, Miami, Florida, United States, 33137-3254
Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827, Metairie, Louisiana, United States, 70006
Delricht Research /ID# 249825, New Orleans, Louisiana, United States, 70115
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
AbbVie,
ABBVIE INC., STUDY_DIRECTOR, AbbVie
2025-12