BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

AbbVie

Status and phase: Completed; Phase 3

Conditions: Masseter Muscle Prominence

Treatments: Other: Placebo; Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073303

1789-301-008

Details and patient eligibility

About

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

Enrollment: 377 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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377 participants in 2 patient groups, including a placebo group

Botulinum Toxin Type A (BOTOX®)

Active Comparator group

Description:

Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments

Treatment:

Biological: Botulinum Toxin Type A

Placebo

Placebo Comparator group

Description:

Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter

Treatment:

Other: Placebo