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A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants
Sponsor: AbbVie
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.
Official title: BOTOX VISTA® (onabotulinumtoxinA) for Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
259
Start Date
2023-11-22
Completion Date
2025-07-31
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
BOTOX
Intramuscular Injection
Placebo for BOTOX
Intramuscular Injection
Locations (18)
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