Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy

Phase 2CompletedNCT02010775

Allergan187 enrolled

Overview

This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

187

Conditions

Masseter Muscle Hypertrophy

Interventions

botulinum toxin Type ABIOLOGICAL

Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Normal salineDRUG

Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: -Participants with Masseter Muscle Hypertrophy Exclusion Criteria: * Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face * History of dental or surgical procedure for lower facial shaping or masseter muscle reduction * History of or current temporomandibular joint disorder (TMJD)

Locations (14)

Shape Clinic

Darlinghurst, New South Wales, Australia

Central Sydney Dermatology

Sydney, New South Wales, Australia

Esteem Beauty & Day Spa

Main Beach, Queensland, Australia

Outcomes

Primary Outcomes

Change From Baseline in Lower Facial Volume Using VECTRA 3D Images

Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.

Time frame: Baseline (Day 1) to Day 90 of Treatment Cycle 1

Secondary Outcomes

Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator

The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.

Time frame: Day 90 of Treatment Cycle 1

Data from ClinicalTrials.gov

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