A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants
NCT ID: NCT06399718
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2024-04-30
2025-11-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Double-Blind Period: BOTOX
Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.
BOTOX
Intramuscular Injections
Double-Blind Period: Placebo
Participants will receive placebo injections across both the right and left masseter muscle on Day 1.
Placebo
Intramuscular Injections
Open-Label Period: BOTOX
Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months.
BOTOX
Intramuscular Injections
Interventions
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BOTOX
Intramuscular Injections
Placebo
Intramuscular Injections
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Westside Aesthetics /ID# 248232
Los Angeles, California, United States
Private Practice - Dr. Steven G. Yoelin /ID# 268046
Newport Beach, California, United States
Pacific Clinical Innovations /ID# 248231
Vista, California, United States
Sherber + RAD /ID# 248894
Washington D.C., District of Columbia, United States
Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478
Boca Raton, Florida, United States
Skin Research Institute LLC /ID# 248230
Coral Gables, Florida, United States
Kavali Plastic Surgery and Skin Renewal Center /ID# 248480
Atlanta, Georgia, United States
DeNova Research /ID# 248237
Chicago, Illinois, United States
DelRicht Research /ID# 250313
Baton Rouge, Louisiana, United States
Etre Cosmetic Dermatology and Laser Center /ID# 248229
New Orleans, Louisiana, United States
Aesthetic Center at Woodholme /ID# 248481
Baltimore, Maryland, United States
Michigan Center for Research Corporation /ID# 249145
Clinton Township, Michigan, United States
Skin Specialists /ID# 248233
Omaha, Nebraska, United States
Laser & Skin Surgery Center of New York /ID# 248479
New York, New York, United States
Luxurgery /ID# 248236
New York, New York, United States
The Practice of Brian S. Biesman MD PLLC /ID# 248226
Nashville, Tennessee, United States
Sherman Aesthetic Center /ID# 248482
Nashville, Tennessee, United States
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 249875
Austin, Texas, United States
DermResearch Inc. /ID# 248227
Austin, Texas, United States
Austin Institute for Clinical Research at SBA Dermatology /ID# 248228
Houston, Texas, United States
Countries
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Related Links
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Other Identifiers
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M21-417
Identifier Type: -
Identifier Source: org_study_id
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