Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
NCT ID: NCT02010775
Last Updated: 2019-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2014-01-20
2017-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BOTOX® 24U
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
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
BOTOX® 48U
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
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
BOTOX® 72U
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
Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
BOTOX® 96U
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.
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.
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Normal saline
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Interventions
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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.
Normal saline
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
50 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Beta Bowen
Role: STUDY_DIRECTOR
Allergan
Locations
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Shape Clinic
Darlinghurst, New South Wales, Australia
Central Sydney Dermatology
Sydney, New South Wales, Australia
Esteem Beauty & Day Spa
Main Beach, Queensland, Australia
The Rose Medical & Aesthetic Centre
North Fremantle, Western Australia, Australia
Dr. Jean Carruthers Cosmetic Surgery, Inc.
Vancouver, British Columbia, Canada
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, Canada
Project Skin MD
Vancouver, British Columbia, Canada
Pacific Dermaesthetics
Vancouver, British Columbia, Canada
Bertucci MedSpa
Woodbridge, Ontario, Canada
Arthur Swift Research Inc.
Montreal, Quebec, Canada
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Chang Gung Memorial Hospital of CGMF
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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More Information
Other Identifiers
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191622-130
Identifier Type: -
Identifier Source: org_study_id
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