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

Last updated: December 3, 2024
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

BOTOX

Placebo

Clinical Study ID

NCT06399718
M21-417
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant meets the following criteria:

  • Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical gradesfor left and right sides of the face), as determined by the investigator usingthe Masseter Muscle Prominence Scale (MMPS).

  • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides ofthe face), as determined by the participant using the Masseter MuscleProminence 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.

Exclusion

Exclusion Criteria:

  • Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid glandprominence that could interfere with MMPS or MMPS-P grading.

  • Asymmetry of left and right sides of the face that could prevent identical MMPS orMMPS-P grading on both sides of the face.

  • History of or current temporomandibular disorder (TMJD), or presence ofsigns/symptoms of possible TMJD.

Study Design

Total Participants: 207
Treatment Group(s): 2
Primary Treatment: BOTOX
Phase: 3
Study Start date:
April 30, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Westside Aesthetics /ID# 248232

    Los Angeles, California 90025-1708
    United States

    Site Not Available

  • Private Practice - Dr. Steven G. Yoelin /ID# 268046

    Newport Beach, California 92663
    United States

    Site Not Available

  • Pacific Clinical Innovations /ID# 248231

    Vista, California 92083-6030
    United States

    Site Not Available

  • Sherber + RAD /ID# 248894

    Washington, District of Columbia 20005-5002
    United States

    Site Not Available

  • Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478

    Boca Raton, Florida 33431-6465
    United States

    Site Not Available

  • Skin Research Institute LLC /ID# 248230

    Coral Gables, Florida 33146-1837
    United States

    Site Not Available

  • Kavali Plastic Surgery and Skin Renewal Center /ID# 248480

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • DeNova Research /ID# 248237

    Chicago, Illinois 60611
    United States

    Site Not Available

  • DelRicht Research /ID# 250313

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Etre Cosmetic Dermatology and Laser Center /ID# 248229

    New Orleans, Louisiana 70130-4353
    United States

    Site Not Available

  • Aesthetic Center at Woodholme /ID# 248481

    Baltimore, Maryland 21208-6391
    United States

    Site Not Available

  • Michigan Center for Research Corporation /ID# 249145

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Skin Specialists /ID# 248233

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Skin Specialists, PC /ID# 248233

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Laser & Skin Surgery Center of New York /ID# 248479

    New York, New York 10016-4974
    United States

    Site Not Available

  • Luxurgery /ID# 248236

    New York, New York 10021
    United States

    Site Not Available

  • Sherman Aesthetic Center /ID# 248482

    Nashville, Tennessee 37205-2205
    United States

    Site Not Available

  • The Practice of Brian S. Biesman MD PLLC /ID# 248226

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • DermResearch Inc. /ID# 248227

    Austin, Texas 78759
    United States

    Site Not Available

  • Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875

    Austin, Texas 78746-4720
    United States

    Site Not Available

  • Austin Institute for Clinical Research at SBA Dermatology /ID# 248228

    Houston, Texas 77056-4129
    United States

    Site Not Available

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