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

• Status: Recruiting
• Trial end date: 2025-11-25
• Target enrollment: 0
• Participant gender: All

Summary

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominice (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP.

BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is 1 in 4 chance that participants will be assigned to placebo. Around 248 adult participants with MMP will be enrolled in the study at approximately 30 sites in Europe.

Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to the masseter on Day 1. Participants who are eligible for retreatment will be given BOTOX on Day 180 and will be followed 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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

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.