A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Study Identifier
2042-201-008
CT.gov Identifier
NCT05100199
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
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Plain Language Summary
Available Language(s): English
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Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • OnabotulinumtoxinA X
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator. * Participant has moderate or severe GL at maximum frown.
    Exclusion Criteria:
    * History of known immunization to any botulinum toxin serotype. * History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class. * Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including: * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function. * Facial nerve palsy. * Infection or dermatological condition at the site of study drug injection.

    Protocol Summary

    This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.

    Study Locations

    Location
    Status
    Location
    Advanced Research Associates - Glendale /ID# 230418
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Westside Aesthetics /ID# 230305
    Los Angeles, California, United States, 90025-1708
    Status
    Not applicable
    Location
    The Eye Research Foundation /ID# 232544
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
    Location
    The Research Center at The Maas Clinic /ID# 230685
    San Francisco, California, United States, 94115-1809
    Status
    Not applicable
    Location
    Center for Dermatology and Dermatologic Surgery /ID# 230684
    Washington D.C., District of Columbia, United States, 20037-1445
    Status
    Not applicable
    Location
    Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
    Boca Raton, Florida, United States, 33431-6465
    Status
    Not applicable
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