NCT04073303
Brief summary
This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
Inclusion Criteria:
- Masseter prominence at the Day 1 visit
- BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/[height (m)]2
- A female participant must be willing to minimize the risk of inducing pregnancy for
the duration of the clinical study and follow-up periods
Exclusion Criteria:
- Any 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
- An anticipated need for surgery or overnight hospitalization during the study
- An anticipated need for treatment with botulinum toxin of any serotype for any
indication during the study (other than study intervention)
- History of dental or surgical procedure for lower facial shaping or masseter muscle
reduction
- Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue
fillers, synthetic implantations, autologous fat transplantation, fat-reducing
injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1
- Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower
face at any time, or to any other part of the body within the 6 months prior to Day
1
- History of temporomandibular joint disorder (TMJD)
- Masseter prominence due to other etiologies (eg, parotid gland infection,
parotiditis, malignancy)
- Known allergy or sensitivity to any of the components of the study treatments or any
materials used in the study procedures
- History of alcohol or drug abuse within 12 months of Day 1