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

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 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.

Key facts

Study ID

NCT06387394

Run by

AbbVie

People needed

202

Starts

2024-04-22

Expected to finish

2025-11-25

Last updated by the study team

2025-12-11

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 at 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

• 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
• Clarkston Dermatology /ID# 248888 — Clarkston, Michigan, United States
• Skin Laser and Surgery Specialists of NY and NJ /ID# 251501 — Hackensack, New Jersey, United States
• Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 248887 — Latham, New York, United States
• Wilmington Dermatology Center /ID# 250651 — Wilmington, North Carolina, United States
• Centricity Research Dublin Multispecialty /ID# 248484 — Dublin, Ohio, United States
• Tennessee Clinical Research Center /ID# 248486 — Nashville, Tennessee, United States
• Bellaire Dermatology Associates /ID# 248221 — Bellaire, Texas, United States
• Dallas Plastic Surgery Institute /ID# 248220 — Dallas, Texas, United States
• Austin Institute for Clinical Research - Pflugerville /ID# 248217 — Pflugerville, Texas, United States
• SkinDC /ID# 248885 — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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