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

Masseter Muscle Prominence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137287
• Other study ID #: M22-080
• Status: Recruiting
• Phase: Phase 3
• Start date: November 22, 2023
• Est. completion date: January 10, 2026

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: AbbVie GK Clinical Trial Registration Desk
• Phone: +81-3-4577-1111
• Email: abbvie_jpn_info_clingov[@]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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 10, 2026
• Est. primary completion date: January 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Masseter Muscle Prominence

Intervention

Drug:
• BOTOX
Intramuscular Injection
• Placebo for BOTOX
Intramuscular Injection

Locations

Country	Name	City	State
Japan	Tokyo Center Clinic /ID# 254775	Central District	Tokyo
Japan	Ginza Skin Clinic /ID# 254666	Chuo-ku	Tokyo
Japan	Tokyo Asbo Clinic /ID# 257728	Chuo-ku	Tokyo
Japan	Skin Clinic Fujieda /ID# 254214	Fujieda-shi	Shizuoka
Japan	Jyosui Dermatology Clinic /ID# 254300	Fukuoka-shi	Fukuoka
Japan	Tokai University Hospital /ID# 254204	Isehara-shi	Kanagawa
Japan	Ecru Clinic /ID# 256505	Kyoto-shi	Kyoto
Japan	Azabu Beauty Clinic ANNEX /ID# 254519	Minato-ku	Tokyo
Japan	Kitasato University Kitasato Institute Hospital /ID# 255369	Minato-ku	Tokyo
Japan	Roppongi Imaizumi Skin Clinic /ID# 254573	Minato-ku	Tokyo
Japan	Jun Clinic /Id# 254870	Nagano
Japan	Touyama Plastic Surgery Clinic /ID# 254831	Naha-shi	Okinawa
Japan	Chiharu Dermatology Clinic /ID# 254778	Saitama-shi	Saitama
Japan	Dermatology and Ophthalmology Kume Clinic /ID# 254632	Sakai-shi	Osaka
Japan	Kotoni tower Skin and Cosmetic Surgery Clinic /ID# 260668	Sapporo-shi
Japan	Greenwood skin clinic Tachikawa /ID# 254830	Tachikawa-shi	Tokyo
Japan	Ikebukuronishiguchi Fukurou Dermatology Clinic /ID# 254639	Toshima-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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	Up to approximately 12 months
Secondary	Change from Baseline in Lower Facial Volume (cm^3)	Photographic technologies developed to provide 3D quantitative analysis of facial morphology include image subtraction technique, moire topography, liquid crystal scanning, light luminance scanning, laser scanning, stereo-lithography, and passive stereophotogrammetry, which all measure change to the lower facial contour.	Baseline to Day 90
Secondary	Change from Baseline in Lower Facial Width (mm)	Photographic technologies developed to provide 3D quantitative analysis of facial morphology include image subtraction technique, moire topography, liquid crystal scanning, light luminance scanning, laser scanning, stereo-lithography, and passive stereophotogrammetry, which all measure change to the lower facial contour.	Baseline to Day 90
Secondary	Percentage of Participants with Responses of Very Satisfied or Satisfied on the Lower Facial Shape Questionnaire - Treatment Satisfaction (LFSQ-TXSAT) Follow-Up Version	The LFSQ-TXSAT at follow-up measures the participant's satisfaction with the effect of treatment on the appearance of their lower face based on a 5-point scale where 2 = very satisfied and -2 = very dissatisfied.	Day 90
Secondary	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)	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 where 0 = not at all bothered and 4 = extremely bothered.	Day 90
Secondary	Percentage of Participants who Achieve >= 2-Grade Improvement on Masseter Muscle Prominence Scale - Participant (MMPS-P)	The MMPS-P is a patient reported outcomes (PRO) measure with an accompanying photo guide used to assess MMP severity from the participant perspective using a 5-grade scale where 1 = the muscle is not at all noticeable and 5 = the muscle is extremely noticeable.	Baseline to Day 90
Secondary	Change from Baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) Summary Score	The LFSQ-IA is a 6-item assessment that measures psychosocial impact of the appearance of the lower face using a 5-point scale where 0 = not at all and 4 = extremely.	Baseline to Day 90

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