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

Study Identifier
191622-130
CT.gov Identifier
NCT02010775
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • botulinum toxin Type A
  • Normal saline
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 50 Years
    Inclusion and Exclusion 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)

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Shape Clinic
    Darlinghurst, New South Wales, Australia, 2010
    Status
    Not applicable
    Location
    Central Sydney Dermatology
    Sydney, New South Wales, Australia, 2000
    Status
    Not applicable
    Location
    Esteem Beauty & Day Spa
    Main Beach, Queensland, Australia, 4217
    Status
    Not applicable
    Location
    The Rose Medical & Aesthetic Centre
    North Fremantle, Western Australia, Australia, 6159
    Status
    Not applicable
    Location
    Dr. Jean Carruthers Cosmetic Surgery, Inc.
    Vancouver, British Columbia, Canada, V5Z 4E1
    Status
    Not applicable
    Location
    Dr. Shannon Humphrey Inc.
    Vancouver, British Columbia, Canada, V5Z 4E1
    Status
    Not applicable
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