A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants

Completed · Phase 3 · Has a placebo group

Conditions studied: Masseter Muscle Prominence

In brief

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.

Key facts

Study ID

NCT06399718

Run by

AbbVie

People needed

207

Starts

2024-04-30

Expected to finish

2025-11-10

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant meets the following criteria:
• Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS).
• Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P).
• Investigator and participant scoring of MMPS and MMPS-P must be the same.
• Body mass index (BMI) ≤ 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2.

You may not qualify if…

• Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading.
• Asymmetry of left and right sides of the face that could prevent identical MMPS or MMPS-P grading on both sides of the face.
• History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD.

Where it is running

• Westside Aesthetics /ID# 248232 — Los Angeles, California, United States
• Private Practice - Dr. Steven G. Yoelin /ID# 268046 — Newport Beach, California, United States
• Pacific Clinical Innovations /ID# 248231 — Vista, California, United States
• Sherber + RAD /ID# 248894 — Washington D.C., District of Columbia, United States
• Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478 — Boca Raton, Florida, United States
• Skin Research Institute LLC /ID# 248230 — Coral Gables, Florida, United States
• Kavali Plastic Surgery and Skin Renewal Center /ID# 248480 — Atlanta, Georgia, United States
• DeNova Research /ID# 248237 — Chicago, Illinois, United States
• DelRicht Research /ID# 250313 — Baton Rouge, Louisiana, United States
• Etre Cosmetic Dermatology and Laser Center /ID# 248229 — New Orleans, Louisiana, United States
• Aesthetic Center at Woodholme /ID# 248481 — Baltimore, Maryland, United States
• Michigan Center for Research Corporation /ID# 249145 — Clinton Township, Michigan, United States
• Skin Specialists /ID# 248233 — Omaha, Nebraska, United States
• Laser & Skin Surgery Center of New York /ID# 248479 — New York, New York, United States
• Luxurgery /ID# 248236 — New York, New York, United States
• The Practice of Brian S. Biesman MD PLLC /ID# 248226 — Nashville, Tennessee, United States
• Sherman Aesthetic Center /ID# 248482 — Nashville, Tennessee, United States
• Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875 — Austin, Texas, United States
• DermResearch Inc. /ID# 248227 — Austin, Texas, United States
• Austin Institute for Clinical Research at SBA Dermatology /ID# 248228 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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