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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Masseter Muscle Prominence
• Intervention / Treatment: Drug: BOTOX; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121-2119
      • Recruiting
      • Cosmetic Laser Dermatology /ID# 248215
    • Santa Monica, California, United States, 90404-2208
      • Recruiting
      • Ava T. Shamban MD - Santa Monica. /ID# 248886
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Recruiting
      • DMR Research PLLC /ID# 248485
  • Florida
    • Bradenton, Florida, United States, 34209-5642
      • Recruiting
      • Susan H. Weinkle MD /ID# 252063
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Recruiting
      • William P. Coleman, III, M.D., A Professional Medical Corporation /ID# 249827
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Delricht Research /ID# 249825
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Clarkston Dermatology /ID# 248888
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Recruiting
      • Wilmington Dermatology Center /ID# 250651
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Recruiting
      • Centricity Research Dublin Multispecialty /ID# 248484
  • Tennessee
    • Nashville, Tennessee, United States, 37215-2885
      • Recruiting
      • Tennessee Clinical Research Center /ID# 248486
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Recruiting
      • Austin Institute for Clinical Research /ID# 248217
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Recruiting
      • SkinDC /ID# 248885

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double-Blind Period: BOTOX; Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.	Drug: BOTOX; Intramuscular Injections; Other Names: OnabotulinumtoxinA
Placebo Comparator: Double-Blind Period: Placebo; Participants will receive placebo injections across both the right and left masseter muscle on Day 1.	Drug: Placebo; Intramuscular Injections
Experimental: Open-Label Period: BOTOX; 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; Intramuscular Injections; Other Names: OnabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): December 27, 2025
• Study Completion (Estimated): January 26, 2026

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; BOTOX; Masseter Muscle Prominence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A
• Other Study ID Numbers: M21-416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No