A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
NCT ID: NCT06387394
Last Updated: 2025-12-11
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
202 participants
INTERVENTIONAL
2024-04-22
2025-11-25
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 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.
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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 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
* 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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Total Skin and Beauty Dermatology Center /ID# 248218
Birmingham, Alabama, United States
Mayo Clinic Arizona /ID# 248883
Phoenix, Arizona, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 248223
Los Angeles, California, United States
Cosmetic Laser Dermatology /ID# 248215
San Diego, California, United States
Ava T. Shamban MD - Santa Monica. /ID# 248886
Santa Monica, California, United States
DMR Research PLLC /ID# 248485
Westport, Connecticut, United States
Susan H. Weinkle MD /ID# 252063
Bradenton, Florida, United States
Skin and Cancer Associates, LLP /ID# 248209
Miami, Florida, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 249827
Metairie, Louisiana, United States
Delricht Research /ID# 249825
New Orleans, Louisiana, United States
Clarkston Dermatology /ID# 248888
Clarkston, Michigan, United States
Skin Laser and Surgery Specialists of NY and NJ /ID# 251501
Hackensack, New Jersey, United States
Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 248887
Latham, New York, United States
Wilmington Dermatology Center /ID# 250651
Wilmington, North Carolina, United States
Centricity Research Dublin Multispecialty /ID# 248484
Dublin, Ohio, United States
Tennessee Clinical Research Center /ID# 248486
Nashville, Tennessee, United States
Bellaire Dermatology Associates /ID# 248221
Bellaire, Texas, United States
Dallas Plastic Surgery Institute /ID# 248220
Dallas, Texas, United States
Austin Institute for Clinical Research - Pflugerville /ID# 248217
Pflugerville, Texas, United States
SkinDC /ID# 248885
Arlington, Virginia, United States
Countries
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Related Links
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Other Identifiers
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M21-416
Identifier Type: -
Identifier Source: org_study_id
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