Back to resultsBotulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Primary Purpose
Masseter Muscle Hypertrophy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
botulinum toxin Type A
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Masseter Muscle Hypertrophy
Eligibility Criteria
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)
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
BOTOX® 24U
BOTOX® 48U
BOTOX® 72U
BOTOX® 96U
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02010775
Brief Title
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Official Title
BOTOX® Treatment of Masseter Muscle Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2014 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Masseter Muscle Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX® 24U
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BOTOX® 48U
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BOTOX® 72U
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BOTOX® 96U
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Primary Outcome Measure Information:
Title
Change From Baseline in Lower Facial Volume Using VECTRA 3D Images
Description
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 Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beta Bowen
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Shape Clinic
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Central Sydney Dermatology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Esteem Beauty & Day Spa
City
Main Beach
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
The Rose Medical & Aesthetic Centre
City
North Fremantle
State/Province
Western Australia
ZIP/Postal Code
6159
Country
Australia
Facility Name
Dr. Jean Carruthers Cosmetic Surgery, Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Dr. Shannon Humphrey Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Project Skin MD
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 1K9
Country
Canada
Facility Name
Pacific Dermaesthetics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 4E1
Country
Canada
Facility Name
Bertucci MedSpa
City
Woodbridge
State/Province
Ontario
ZIP/Postal Code
L4L 8E2
Country
Canada
Facility Name
Arthur Swift Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 1B7
Country
Canada
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
80735
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10041
Country
Taiwan
Facility Name
Taipei Chang Gung Memorial Hospital of CGMF
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11411
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information
Learn more about this trial
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
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