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

Study Identifier
M21-417
CT.gov Identifier
NCT06399718
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 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 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.

    Study Locations

    Location
    Status
    Location
    Westside Aesthetics /ID# 248232
    Los Angeles, California, United States, 90025-1708
    Status
    Not applicable
    Location
    Private Practice - Dr. Steven G. Yoelin /ID# 268046
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Pacific Clinical Innovations /ID# 248231
    Vista, California, United States, 92083-6030
    Status
    Not applicable
    Location
    Sherber + RAD /ID# 248894
    Washington D.C., District of Columbia, United States, 20005-5002
    Status
    Not applicable
    Location
    Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 248478
    Boca Raton, Florida, United States, 33431-6465
    Status
    Not applicable
    Location
    Skin Research Institute LLC /ID# 248230
    Coral Gables, Florida, United States, 33146-1837
    Status
    Not applicable
    Showing {first} - {last} of {total} Results