Clinical trial NCT06137287: A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants
Official title: BOTOX VISTA® (onabotulinumtoxinA) for Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Masseter Muscle Prominence
Keywords: Masseter Muscle Prominence
OnabotulinumtoxinA
BOTOX VISTA
BOTOX
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants who Achieve >= 2-Grade Improvement on Investigator-Rated Masseter Muscle Prominence Scale (MMPS)
timeFrame: Baseline to Day 90
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Change from Baseline in Lower Facial Volume (cm^3)
timeFrame: Baseline to Day 90
measure: Change from Baseline in Lower Facial Width (mm)
timeFrame: Baseline to Day 90
measure: Percentage of Participants with Responses of Very Satisfied or Satisfied on the Lower Facial Shape Questionnaire - Treatment Satisfaction (LFSQ-TXSAT) Follow-Up Version
timeFrame: Day 90
measure: 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)
timeFrame: Day 90
measure: Percentage of Participants who Achieve >= 2-Grade Improvement on Masseter Muscle Prominence Scale - Participant (MMPS-P)
timeFrame: Baseline to Day 90
measure: Change from Baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) Summary Score
timeFrame: Baseline to Day 90
Other outcomes:
Locations:
city: Nagano
country: Japan
facility: Jun Clinic /Id# 254870
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Jyosui Dermatology Clinic /ID# 254300
state: Fukuoka
city: Sapporo
country: Japan
facility: Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 260668
state: Hokkaido
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 254204
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Ecru Clinic /ID# 256505
state: Kyoto
city: Naha-shi
country: Japan
facility: Touyama Plastic Surgery Clinic /ID# 254831
state: Okinawa
city: Sakai-shi
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic /ID# 254632
state: Osaka
city: Fujieda-shi
country: Japan
facility: Skin Clinic Fujieda /ID# 254214
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic /ID# 254775
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Asbo Clinic /ID# 257728
state: Tokyo
city: Chuo-ku
country: Japan
facility: Ginza Skin Clinic /ID# 254666
state: Tokyo
city: Meguro-ku
country: Japan
facility: Jiyugaoka Clinic /ID# 256666
state: Tokyo
city: Minato City
country: Japan
facility: Azabu beauty clinic ANNEX /ID# 254519
state: Tokyo
city: Minato-ku
country: Japan
facility: Roppongi Imaizumi Skin Clinic /ID# 254573
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 255369
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Greenwood skin clinic Tachikawa /ID# 254830
state: Tokyo
city: Toshima-ku
country: Japan
facility: Ikebukuronishiguchi Fukurou Dermatology Clinic /ID# 254639
state: Tokyo
city: Saitama
country: Japan
facility: Chiharu Dermatology Clinic Urawa /ID# 254778
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: