A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

Overview

About this study

The purpose of this study is to assess adverse events and effectiveness of BOTOX in adult participants with masseter muscle prominence (MMP). BOTOX is being investigated for the treatment of MMP.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Body mass index < 30 kg/m^2 using the calculation: BMI = weight (kg)/height (m)^2,
rounded to the nearest whole number.

- Participants meets the following criteria:

- Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right side of the
face), as determined at screening and at the Day 1 visit by the investigator
using the MMPS.

- Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of
the face), as determined at the Day 1 visit by the participant using the MMPS-P.

- MMP grades, as assessed by investigator and participant, do not need to be
identical but have to be a minimum of Grade 4 with bilateral symmetry at Day 1.

- Participants who responded "A lot" or "Extremely" bothered by the appearance of their
MMP as measured by the Bother Impact Assessment for Masseter Muscle Prominence
(BIA-MMP) and attain a total score of ≥ 15 on the Lower Facial Shape Questionnaire -
Impact Assessment (LFSQ-IA), determined at the Day 1 visit.

Exclusion Criteria:

- Has current intraoral infection, including infection of the mouth or gums, or facial
skin infection requiring medical treatment in the opinion of the investigator.

- Has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial
nerve injury, or other condition that could interfere with normal chewing and jaw
clenching, as determined by the investigator.

- 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, as determined by the
investigator.

- Has medical condition that may put the participant at increased medical risk with
exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome,
amyotrophic lateral sclerosis, or any other condition that might interfere with
neuromuscular function.

- History of dental or surgical procedure for lower facial shaping or masseter muscle
reduction.

- History of any soft tissue fillers in the jawline.

- Has prior exposure to botulinum toxin of any serotype to any part of the body (not
including masseter muscle) within the 3 months prior to Day 1.

- History of or current TMJD, or presence of signs/symptoms of possible TMJD in the
opinion of the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/2/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lisa Grunebaum, M.D.

Open for enrollment

Contact information:

Arleth Valencia

(480) 342-6487

Valencia.Arleth@mayo.edu

More information

Publications

Publications are currently not available