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

NCT ID: NCT06137287

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

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.

Group Type: EXPERIMENTAL

BOTOX

Intervention Type: DRUG

Intramuscular Injection

Group 2

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.

Group Type: EXPERIMENTAL

BOTOX

Intervention Type: DRUG

Intramuscular Injection

Group 3

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.

Group Type: EXPERIMENTAL

BOTOX

Intervention Type: DRUG

Intramuscular Injection

Placebo for BOTOX

Intervention Type: DRUG

Intramuscular Injection

Group 4

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.

Group Type: EXPERIMENTAL

BOTOX

Intervention Type: DRUG

Intramuscular Injection

Placebo for BOTOX

Intervention Type: DRUG

Intramuscular Injection

Interventions

BOTOX

Intramuscular Injection

Intervention Type: DRUG

Placebo for BOTOX

Intramuscular Injection

Intervention Type: DRUG

Other Intervention Names

BOTOX VISTA; OnabotulinumtoxinA

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Jyosui Dermatology Clinic /ID# 254300

Fukuoka, Fukuoka, Japan

Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 260668

Sapporo, Hokkaido, Japan

Tokai University Hospital /ID# 254204

Isehara, Kanagawa, Japan

Yoshikawa Skin Ecru Clinic /ID# 256505

Kyoto, Kyoto, Japan

Touyama Plastic Surgery Clinic /ID# 254831

Naha, Okinawa, Japan

Dermatology and Ophthalmology Kume Clinic /ID# 254632

Sakai-shi, Osaka, Japan

Skin Clinic Fujieda /ID# 254214

Fujieda-shi, Shizuoka, Japan

Tokyo Center Clinic /ID# 254775

Chuo-ku, Tokyo, Japan

Tokyo Asbo Clinic /ID# 257728

Chuo-ku, Tokyo, Japan

Ginza Skin Clinic /ID# 254666

Chuo-ku, Tokyo, Japan

Jiyugaoka Clinic /ID# 256666

Meguro-ku, Tokyo, Japan

Azabu beauty clinic /ID# 254519

Minato, Tokyo, Japan

Roppongi Imaizumi Skin Clinic /ID# 254573

Minato-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital /ID# 255369

Minato-ku, Tokyo, Japan

Greenwood Skin Clinic Tachikawa /ID# 254830

Tachikawa-shi, Tokyo, Japan

Ikebukuronishiguchi Fukurou Dermatology Clinic /ID# 254639

Toshima-ku, Tokyo, Japan

Jun Clinic /Id# 254870

Nagano, , Japan

Chiharu Dermatology Clinic Urawa /ID# 254778

Saitama, , Japan

Countries

Japan

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M22-080

Related Info

Other Identifiers

M22-080

Identifier Type: -

Identifier Source: org_study_id