A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines

Study Identifier
M21-606
CT.gov Identifier
NCT05152576
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
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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 * Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation
    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. * History of Facial nerve palsy. * Infection or dermatological condition at the site of study drug injection.

    Protocol Summary

    Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.

    Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.

    Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

    Study Locations

    Location
    Status
    Location
    The Eye Research Foundation /ID# 241512
    Newport Beach, California, United States, 92663-3637
    Status
    Not applicable
    Location
    Steve Yoelin MD Medical Associate Inc /ID# 239771
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776
    Mount Kisco, New York, United States, 10549-3028
    Status
    Not applicable
    Location
    Skin Search of Rochester Inc. /ID# 239773
    Rochester, New York, United States, 14623
    Status
    Not applicable
    Location
    Dermatology Consulting Service /ID# 239779
    High Point, North Carolina, United States, 27262
    Status
    Not applicable
    Location
    Wilmington Dermatology Center /ID# 239778
    Wilmington, North Carolina, United States, 28403
    Status
    Not applicable
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