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

Masseter Muscle Hypertrophy Clinical Trial

Official title:

BOTOX® Treatment of Masseter Muscle Hypertrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010775
• Other study ID #: 191622-130
• Status: Completed
• Phase: Phase 2
• Start date: January 20, 2014
• Est. completion date: November 29, 2017

Study information

• Verified date: February 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: November 29, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertrophy
• Masseter Muscle Hypertrophy

Intervention

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

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

Locations

Country	Name	City	State
Australia	Shape Clinic	Darlinghurst	New South Wales
Australia	Esteem Beauty & Day Spa	Main Beach	Queensland
Australia	The Rose Medical & Aesthetic Centre	North Fremantle	Western Australia
Australia	Central Sydney Dermatology	Sydney	New South Wales
Canada	Arthur Swift Research Inc.	Montreal	Quebec
Canada	Dr. Jean Carruthers Cosmetic Surgery, Inc.	Vancouver	British Columbia
Canada	Dr. Shannon Humphrey Inc.	Vancouver	British Columbia
Canada	Pacific Dermaesthetics	Vancouver	British Columbia
Canada	Project Skin MD	Vancouver	British Columbia
Canada	Bertucci MedSpa	Woodbridge	Ontario
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Chang Gung Memorial Hospital of CGMF	Taipei
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Australia,  Canada,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 1) to Day 90 of Treatment Cycle 1
Secondary	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.	Day 90 of Treatment Cycle 1

External Links

•   More Information