Clinical trial NCT06399718: A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants
Official title: BOTOX® (onabotulinumtoxinA) for the Reduction of 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: BOTOX
OnabotulinumtoxinA
Masseter Muscle Prominence
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_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. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).

BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.

Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given a BOTOX injection on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Participant meets the following criteria:

  * Bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) (identical grades for left and right sides of the face), as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS).
  * Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P).
  * Investigator and participant scoring of MMPS and MMPS-P must be the same.
* Body mass index (BMI) ≤ 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2.

Exclusion Criteria:

* Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading.
* Asymmetry of left and right sides of the face that could prevent identical MMPS or MMPS-P grading on both sides of the face.
* History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD.

Primary outcomes:
measure: Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P
timeFrame: Day 90
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Day 360
Secondary outcomes:
measure: Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT)
timeFrame: Day 90
measure: Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP)
timeFrame: Day 90
measure: Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score
timeFrame: Baseline to Day 90
measure: Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time
timeFrame: Baseline to Day 360
measure: Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time
timeFrame: Baseline to Day 360
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Westside Aesthetics /ID# 248232
state: California
city: Newport Beach
country: United States
facility: Private Practice - Dr. Steven G. Yoelin /ID# 268046
state: California
city: Vista
country: United States
facility: Pacific Clinical Innovations /ID# 248231
state: California
city: Washington
country: United States
facility: Sherber + RAD /ID# 248894
state: District of Columbia
city: Boca Raton
country: United States
facility: Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 248230
state: Florida
city: Atlanta
country: United States
facility: Kavali Plastic Surgery and Skin Renewal Center /ID# 248480
state: Georgia
city: Chicago
country: United States
facility: DeNova Research /ID# 248237
state: Illinois
city: Baton Rouge
country: United States
facility: DelRicht Research /ID# 250313
state: Louisiana
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center /ID# 248229
state: Louisiana
city: Baltimore
country: United States
facility: Aesthetic Center at Woodholme /ID# 248481
state: Maryland
city: Clinton Township
country: United States
facility: Michigan Center for Research Corporation /ID# 249145
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists /ID# 248233
state: Nebraska
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York /ID# 248479
state: New York
city: New York
country: United States
facility: Luxurgery /ID# 248236
state: New York
city: Nashville
country: United States
facility: The Practice of Brian S. Biesman MD PLLC /ID# 248226
state: Tennessee
city: Nashville
country: United States
facility: Sherman Aesthetic Center /ID# 248482
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875
state: Texas
city: Austin
country: United States
facility: DermResearch Inc. /ID# 248227
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research at SBA Dermatology /ID# 248228
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: