A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants

NCT06137287 | Completed Phase 3

• 1 other identifier: M22-080
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 18

Brief Summary

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominence (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP. BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is 1 in 5 chance that participants will be assigned to placebo. Around 250 adult participants with MMP will be enrolled in the study at approximately 20 sites in Japan. Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to each masseter muscle on Day 1. Participants who are eligible for retreatment will be given BOTOX on either Day 180, 210, 240, or 270 and will be followed until approximately Day 360. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, facial photography, checking for side effects and completing questionnaires.

Conditions

Masseter Muscle Prominence

Keywords

Masseter Muscle Prominence; OnabotulinumtoxinA; BOTOX VISTA; BOTOX

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)

  The MMPS is a photonumeric scale encompassing visual inspection of the masseter muscles as performed by the investigator, where the masseter muscle prominence (MMP) is rated at rest, by separately evaluating the left and right side of the participant's face. The evaluation is on a 5-grade scale where 1 = the masseter muscle prominence is minimal and 5 = the masseter muscle prominence is very marked.

  Baseline to 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

  Up to approximately 12 months

Secondary Outcomes (6)

• Change from Baseline in Lower Facial Volume (cm^3)

  Baseline to Day 90

• Change from Baseline in Lower Facial Width (mm)

  Baseline to Day 90

• Percentage of Participants with Responses of Very Satisfied or Satisfied on the Lower Facial Shape Questionnaire - Treatment Satisfaction (LFSQ-TXSAT) Follow-Up Version

  Day 90

• Responses of Not at All Bothered or A Little Bothered on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) (for Subjects Somewhat Bothered, A Lot Bothered, or Extremely Bothered at Baseline)

  Day 90

• Percentage of Participants who Achieve >= 2-Grade Improvement on Masseter Muscle Prominence Scale - Participant (MMPS-P)

  Baseline to Day 90

Study Arms (4)

Group 1

EXPERIMENTAL

In Period 1, participant will receive 6 injections of BOTOX VISTA Dose A on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270.

Drug: BOTOX

Group 2

EXPERIMENTAL

In Period 1, participant will receive 6 injections of BOTOX VISTA Dose B on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270.

Drug: BOTOX

Group 3

EXPERIMENTAL

In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270.

Drug: BOTOX; Drug: Placebo for BOTOX

Group 4

EXPERIMENTAL

In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270.

Drug: BOTOX; Drug: Placebo for BOTOX

Interventions

BOTOX DRUG

Intramuscular Injection

Also known as: BOTOX VISTA, OnabotulinumtoxinA

Group 1; Group 2; Group 3; Group 4

Placebo for BOTOX DRUG

Intramuscular Injection

Group 3; Group 4

Eligibility Criteria

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

You may qualify if:

• Adult Japanese individuals.
• Participant with marked or very marked masseter muscle prominence (MMP).

You may not qualify if:

• Asymmetry of left and right sides of the face that could prevent identical Masseter Muscle Prominence Scale (MMPS) or MMPS-P grading on both sides of the face, as determined by the investigator.
• History of permanent soft tissue fillers in the jawline.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (18)

Jyosui Dermatology Clinic /ID# 254300

Fukuoka, Fukuoka, 810-0022, Japan

Location

Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 260668

Sapporo, Hokkaido, 063-0812, Japan

Location

Tokai University Hospital /ID# 254204

Isehara, Kanagawa, 259-1193, Japan

Location

Yoshikawa Skin Ecru Clinic /ID# 256505

Kyoto, Kyoto, 604-8035, Japan

Location

Touyama Plastic Surgery Clinic /ID# 254831

Naha, Okinawa, 900-0015, Japan

Location

Dermatology and Ophthalmology Kume Clinic /ID# 254632

Sakai-shi, Osaka, 593-8324, Japan

Location

Skin Clinic Fujieda /ID# 254214

Fujieda-shi, Shizuoka, 426-0067, Japan

Location

Tokyo Center Clinic /ID# 254775

Chuo-ku, Tokyo, 103-0027, Japan

Location

Tokyo Asbo Clinic /ID# 257728

Chuo-ku, Tokyo, 104-0031, Japan

Location

Ginza Skin Clinic /ID# 254666

Chuo-ku, Tokyo, 104-0061, Japan

Location

Jiyugaoka Clinic /ID# 256666

Meguro-ku, Tokyo, 152-0023, Japan

Location

Azabu beauty clinic /ID# 254519

Minato, Tokyo, 106-0032, Japan

Location

Roppongi Imaizumi Skin Clinic /ID# 254573

Minato-ku, Tokyo, 106-0032, Japan

Location

Kitasato University Kitasato Institute Hospital /ID# 255369

Minato-ku, Tokyo, 108-8642, Japan

Location

Greenwood Skin Clinic Tachikawa /ID# 254830

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

Ikebukuronishiguchi Fukurou Dermatology Clinic /ID# 254639

Toshima-ku, Tokyo, 171-0021, Japan

Location

Jun Clinic /Id# 254870

Nagano, 380-0826, Japan

Location

Chiharu Dermatology Clinic Urawa /ID# 254778

Saitama, 333-0055, Japan

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 22, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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

JP (18)