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

NCT06399718 | Completed Phase 3 FDA Drug

• 1 other identifier: M21-417
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Masseter Muscle Prominence

Keywords

BOTOX; OnabotulinumtoxinA; Masseter Muscle Prominence

Outcome Measures

Primary Outcomes (2)

• Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P

  The investigator and participant each assessed the participant's Masseter Muscle Prominence (MMP) using the Masseter Muscle Prominence Scale (MMPS) and the Masseter Muscle Prominence Scale-Participant (MMPS-P), respectively. Both are a 5-point masseter muscle severity scale with grades ranging from 1 (minimal/not at all noticeable) to 5 (very marked/extremely noticeable).

  Day 90

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Baseline to Day 360

Secondary Outcomes (5)

• Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT)

  Day 90

• Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP)

  Day 90

• Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score

  Baseline to Day 90

• Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time

  Baseline to Day 360

• Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time

  Baseline to Day 360

Study Arms (3)

Double-Blind Period: BOTOX

EXPERIMENTAL

Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.

Drug: BOTOX

Double-Blind Period: Placebo

PLACEBO COMPARATOR

Participants will receive placebo injections across both the right and left masseter muscle on Day 1.

Drug: Placebo

Open-Label Period: BOTOX

EXPERIMENTAL

Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months.

Drug: BOTOX

Interventions

BOTOX DRUG

Intramuscular Injections

Also known as: OnabotulinumtoxinA

Double-Blind Period: BOTOX; Open-Label Period: BOTOX

Placebo DRUG

Intramuscular Injections

Double-Blind Period: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (20)

Westside Aesthetics /ID# 248232

Los Angeles, California, 90025-1708, United States

Location

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

Newport Beach, California, 92663, United States

Location

Pacific Clinical Innovations /ID# 248231

Vista, California, 92083-6030, United States

Location

Sherber + RAD /ID# 248894

Washington D.C., District of Columbia, 20005-5002, United States

Location

Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478

Boca Raton, Florida, 33431-6465, United States

Location

Skin Research Institute LLC /ID# 248230

Coral Gables, Florida, 33146-1837, United States

Location

Kavali Plastic Surgery and Skin Renewal Center /ID# 248480

Atlanta, Georgia, 30328, United States

Location

DeNova Research /ID# 248237

Chicago, Illinois, 60610, United States

Location

DelRicht Research /ID# 250313

Baton Rouge, Louisiana, 70809, United States

Location

Etre Cosmetic Dermatology and Laser Center /ID# 248229

New Orleans, Louisiana, 70130-4353, United States

Location

Aesthetic Center at Woodholme /ID# 248481

Baltimore, Maryland, 21208-6391, United States

Location

Michigan Center for Research Corporation /ID# 249145

Clinton Township, Michigan, 48038, United States

Location

Skin Specialists /ID# 248233

Omaha, Nebraska, 68144, United States

Location

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

New York, New York, 10016-4974, United States

Location

Luxurgery /ID# 248236

New York, New York, 10021, United States

Location

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

Nashville, Tennessee, 37203, United States

Location

Sherman Aesthetic Center /ID# 248482

Nashville, Tennessee, 37205-2205, United States

Location

Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875

Austin, Texas, 78746-4720, United States

Location

DermResearch Inc. /ID# 248227

Austin, Texas, 78759, United States

Location

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

Houston, Texas, 77056-4129, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: April 30, 2024
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (20)