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

NCT06387394 | Completed Phase 3 FDA Drug

• 1 other identifier: M21-416
• Study Type: interventional
• Target: 202
• 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 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.

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 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (20)

Total Skin and Beauty Dermatology Center /ID# 248218

Birmingham, Alabama, 35205, United States

Location

Mayo Clinic Arizona /ID# 248883

Phoenix, Arizona, 85054, United States

Location

Skin Care and Laser Physicians of Beverly Hills /ID# 248223

Los Angeles, California, 90069, United States

Location

Cosmetic Laser Dermatology /ID# 248215

San Diego, California, 92121-2119, United States

Location

Ava T. Shamban MD - Santa Monica. /ID# 248886

Santa Monica, California, 90404-2208, United States

Location

DMR Research PLLC /ID# 248485

Westport, Connecticut, 06880, United States

Location

Susan H. Weinkle MD /ID# 252063

Bradenton, Florida, 34209-5642, United States

Location

Skin and Cancer Associates, LLP /ID# 248209

Miami, Florida, 33137-3254, United States

Location

Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827

Metairie, Louisiana, 70006, United States

Location

Delricht Research /ID# 249825

New Orleans, Louisiana, 70115, United States

Location

Clarkston Dermatology /ID# 248888

Clarkston, Michigan, 48346, United States

Location

Skin Laser and Surgery Specialists of NY and NJ /ID# 251501

Hackensack, New Jersey, 07601-1997, United States

Location

Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 248887

Latham, New York, 12110, United States

Location

Wilmington Dermatology Center /ID# 250651

Wilmington, North Carolina, 28403, United States

Location

Centricity Research Dublin Multispecialty /ID# 248484

Dublin, Ohio, 43016, United States

Location

Tennessee Clinical Research Center /ID# 248486

Nashville, Tennessee, 37215-2885, United States

Location

Bellaire Dermatology Associates /ID# 248221

Bellaire, Texas, 77401, United States

Location

Dallas Plastic Surgery Institute /ID# 248220

Dallas, Texas, 75231, United States

Location

Austin Institute for Clinical Research - Pflugerville /ID# 248217

Pflugerville, Texas, 78660, United States

Location

SkinDC /ID# 248885

Arlington, Virginia, 22209, 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: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 22, 2024
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

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)