A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
- Conditions
- Masseter Muscle Prominence
- Interventions
- Drug: Placebo
- Registration Number
- NCT06387394
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 202
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Open-Label Period: BOTOX 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. Double-Blind Period: Placebo Placebo Participants will receive placebo injections across both the right and left masseter muscle on Day 1. Double-Blind Period: BOTOX BOTOX Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.
- Primary Outcome Measures
Name Time Method 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 Day 90 The investigator and participant each assessed the participant's Masseter Muscle Prominence (MMP) using the Masseter Muscle Prominence Scale (MMPS) and the Masseter Muscle Prominence Scale-Participant (MMPS-P), respectively. Both are a 5-point masseter muscle severity scale with grades ranging from 1 (minimal/not at all noticeable) to 5 (very marked/extremely noticeable).
Number of Participants with Adverse Events (AEs) Baseline to Day 360 An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time Baseline to Day 360 The investigator assessed the participant's MMP using the MMPS, a 5-point masseter muscle severity scale with grades ranging from 1 (minimal) to 5 (very marked).
Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT) Day 90 The LFSQ-TXSAT measures satisfaction with the effect of treatment using a 5-point scale ranging from 'Very satisfied' to 'Very dissatisfied.'
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) Day 90 The BIA-MMP is a single item evaluation of how bothered the participant is by the appearance of their lower face using a 5-point scale from 'Not at all bothered' to 'Extremely bothered.'
Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score Baseline to Day 90 The LFSQ-IA measures psychosocial impact due to the appearance of the lower face. The LFSQ-IA summary score ranges from '0 (best)' to '24 (worst).'
Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time Baseline to Day 360 The investigator assessed the participant's MMP using the MMPS-P, a 5-point masseter muscle severity scale with grades ranging from 1 (not at all noticeable) to 5 (extremely noticeable).
Related Research Topics
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Trial Locations
- Locations (20)
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