A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence

Study Identifier
M21-416
CT.gov Identifier
NCT06387394
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • BOTOX
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Center /ID# 248218
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Mayo Clinic Arizona /ID# 248883
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Skin Care and Laser Physicians of Beverly Hills /ID# 248223
    Los Angeles, California, United States, 90069
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 248215
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
    Location
    Ava T. Shamban MD - Santa Monica. /ID# 248886
    Santa Monica, California, United States, 90404-2208
    Status
    Not applicable
    Location
    DMR Research PLLC /ID# 248485
    Westport, Connecticut, United States, 06880
    Status
    Not applicable
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