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).

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

Masseter Muscle Hypertrophy

botulinum toxin Type A

Normal saline

BOTOX® Treatment of Masseter Muscle Hypertrophy

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.

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.

Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Shape Clinic

Central Sydney Dermatology

Esteem Beauty & Day Spa

The Rose Medical & Aesthetic Centre

Dr. Jean Carruthers Cosmetic Surgery, Inc.

Dr. Shannon Humphrey Inc.

Project Skin MD

Pacific Dermaesthetics

Bertucci MedSpa

Arthur Swift Research Inc.

Kaohsiung Medical University Hospital

National Taiwan University Hospital

Taipei Chang Gung Memorial Hospital of CGMF

Tri-Service General Hospital

Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.

BOTOX® 96U

BOTOX® 72U

BOTOX® 48U

BOTOX® 24U

Placebo

Total

Age, Continuous

Sex: Female, Male

Caucasian

Asian

Hispanic

Other Race

Race/Ethnicity, Customized

Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit.

Therapeutic Area, Head

Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Change in lower facial volume was quantified in cm\^3 using image subtraction techniques; as the Baseline is an image, no Baseline data are reported.

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

Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Missing data was imputed using last observation carried forward.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?