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

Masseter Muscle Prominence Clinical Trial

Official title:

BOTOX® (onabotulinumtoxinA) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06399718
• Other study ID #: M21-417
• Status: Recruiting
• Phase: Phase 3
• Start date: April 30, 2024
• Est. completion date: February 24, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 24, 2026
• Est. primary completion date: January 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Masseter Muscle Prominence

Intervention

Drug:
• BOTOX
Intramuscular Injections
• Placebo
Intramuscular Injections

Locations

Country	Name	City	State
United States	Kavali Plastic Surgery and Skin Renewal Center /ID# 248480	Atlanta	Georgia
United States	DermResearch Inc. /ID# 248227	Austin	Texas
United States	Aesthetic Center at Woodholme /ID# 248481	Baltimore	Maryland
United States	DelRicht Research /ID# 250313	Baton Rouge	Louisiana
United States	Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478	Boca Raton	Florida
United States	DeNova Research /ID# 248237	Chicago	Illinois
United States	Michigan Center for Research Corporation /ID# 249145	Clinton Township	Michigan
United States	Skin Research Institute LLC /ID# 248230	Coral Gables	Florida
United States	Austin Institute for Clinical Research at SBA Dermatology /ID# 248228	Houston	Texas
United States	Westside Aesthetics /ID# 248232	Los Angeles	California
United States	The Practice of Brian S. Biesman MD PLLC /ID# 248226	Nashville	Tennessee
United States	Etre Cosmetic Dermatology and Laser Center /ID# 248229	New Orleans	Louisiana
United States	Luxurgery /ID# 248236	New York	New York
United States	Skin Specialists, PC /ID# 248233	Omaha	Nebraska
United States	Pacific Clinical Innovations /ID# 248231	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time	The investigator assessed the participant's MMP using the MMPS, a 5-point masseter muscle severity scale with grades ranging from 1 (minimal) to 5 (very marked).	Baseline to Day 360
Secondary	Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time	The investigator assessed the participant's MMP using the MMPS-P, a 5-point masseter muscle severity scale with grades ranging from 1 (not at all noticeable) to 5 (extremely noticeable).	Baseline to Day 360
Secondary	Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT)	The LFSQ-TXSAT measures satisfaction with the effect of treatment using a 5-point scale ranging from 'Very satisfied' to 'Very dissatisfied.'	Day 90
Secondary	Percentage of Participants who Responded as "Much improved" or "Moderately improved" on the MMP Participant Self-Assessment of Change (MMP-PSAC)	The MMP-PSAC measures change in MMP using a 7-point scale ranging from 'Much improved' to 'Much worse.'	Day 90
Secondary	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)	The BIA-MMP is a single item evaluation of how bothered the participant is by the appearance of their lower face using a 5-point scale from 'Not at all bothered' to 'Extremely bothered.'	Day 90
Secondary	Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score	The LFSQ-IA measures psychosocial impact due to the appearance of the lower face. The LFSQ-IA summary score ranges from '0 (best)' to '24 (worst).'	Baseline to Day 90

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