Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
BOTOX® Treatment of Masseter Muscle Hypertrophy
1 other identifier
interventional
187
3 countries
14
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 13, 2013
CompletedStudy Start
First participant enrolled
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2017
CompletedResults Posted
Study results publicly available
May 28, 2019
CompletedMay 28, 2019
February 1, 2019
3.1 years
December 10, 2013
February 26, 2019
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
Day 90 of Treatment Cycle 1
Study Arms (5)
BOTOX® 24U
ACTIVE COMPARATORBotulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
BOTOX® 48U
ACTIVE COMPARATORBotulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
BOTOX® 72U
ACTIVE COMPARATORBotulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
BOTOX® 96U
ACTIVE COMPARATORBotulinum 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
PLACEBO COMPARATORPlacebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Interventions
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Eligibility Criteria
You may qualify if:
- Participants with Masseter Muscle Hypertrophy
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (14)
Shape Clinic
Darlinghurst, New South Wales, 2010, Australia
Central Sydney Dermatology
Sydney, New South Wales, 2000, Australia
Esteem Beauty & Day Spa
Main Beach, Queensland, 4217, Australia
The Rose Medical & Aesthetic Centre
North Fremantle, Western Australia, 6159, Australia
Dr. Jean Carruthers Cosmetic Surgery, Inc.
Vancouver, British Columbia, V5Z 4E1, Canada
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, V5Z 4E1, Canada
Project Skin MD
Vancouver, British Columbia, V6H 1K9, Canada
Pacific Dermaesthetics
Vancouver, British Columbia, V6H 4E1, Canada
Bertucci MedSpa
Woodbridge, Ontario, L4L 8E2, Canada
Arthur Swift Research Inc.
Montreal, Quebec, H3Z 1B7, Canada
Kaohsiung Medical University Hospital
Kaohsiung City, 80735, Taiwan
National Taiwan University Hospital
Taipei, 10041, Taiwan
Taipei Chang Gung Memorial Hospital of CGMF
Taipei, 10507, Taiwan
Tri-Service General Hospital
Taipei, 11411, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Beta Bowen
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 13, 2013
Study Start
January 20, 2014
Primary Completion
March 7, 2017
Study Completion
November 29, 2017
Last Updated
May 28, 2019
Results First Posted
May 28, 2019
Record last verified: 2019-02