Clinical trial NCT06387394: A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
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: 2024-04-29
Enrollment: 202
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 BOTOX injections 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 at 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: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center /ID# 248218
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 248883
state: Arizona
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills /ID# 248223
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 248215
state: California
city: Santa Monica
country: United States
facility: Ava T. Shamban MD - Santa Monica. /ID# 248886
state: California
city: Westport
country: United States
facility: DMR Research PLLC /ID# 248485
state: Connecticut
city: Bradenton
country: United States
facility: Susan H. Weinkle MD /ID# 252063
state: Florida
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 248209
state: Florida
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research /ID# 249825
state: Louisiana
city: Clarkston
country: United States
facility: Clarkston Dermatology /ID# 248888
state: Michigan
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NY and NJ /ID# 251501
state: New Jersey
city: Latham
country: United States
facility: Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 248887
state: New York
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 250651
state: North Carolina
city: Dublin
country: United States
facility: Centricity Research Dublin Multispecialty /ID# 248484
state: Ohio
city: Nashville
country: United States
facility: Tennessee Clinical Research Center /ID# 248486
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 248221
state: Texas
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 248220
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research - Pflugerville /ID# 248217
state: Texas
city: Arlington
country: United States
facility: SkinDC /ID# 248885
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: