BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

1789-301-008

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

2019-08-29

2022-11-10

2022-11-10

Completed

Early phase I

376

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 376, 'type': 'ACTUAL'}}

2023-10-17