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

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: NCT06387394
• Other study ID #: M21-416
• Status: Recruiting
• Phase: Phase 3
• Start date: April 22, 2024
• Est. completion date: December 21, 2025

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 21, 2025
• Est. primary completion date: December 21, 2025
• 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 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.

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	SkinDC /ID# 248885	Arlington	Virginia
United States	Bellaire Dermatology Associates /ID# 248221	Bellaire	Texas
United States	Total Skin and Beauty Dermatology Center /ID# 248218	Birmingham	Alabama
United States	Susan H. Weinkle MD /ID# 252063	Bradenton	Florida
United States	Clarkston Dermatology /ID# 248888	Clarkston	Michigan
United States	Dallas Plastic Surgery Institute /ID# 248220	Dallas	Texas
United States	Centricity Research Dublin Multispecialty /ID# 248484	Dublin	Ohio
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	Skin Care and Laser Physicians of Beverly Hills /ID# 248223	Los Angeles	California
United States	Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827	Metairie	Louisiana
United States	Tennessee Clinical Research Center /ID# 248486	Nashville	Tennessee
United States	Delricht Research /ID# 249825	New Orleans	Louisiana
United States	Austin Institute for Clinical Research - Pflugerville /ID# 248217	Pflugerville	Texas
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	Wilmington Dermatology Center /ID# 250651	Wilmington	North Carolina

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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