A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Study Identifier
M21-324
CT.gov Identifier
NCT05013424
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
  • Formulation A: OnabotulinumtoxinA
  • Formulation B: OnabotulinumtoxinA
  • Formulation C: OnabotulinumtoxinA
    • Phase
    Phase 2
    Sex
    Female
    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 severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.
    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 OnabotA 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 * Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart * Any eyebrow or eyelid ptosis at baseline or Day 1 as determined by the investigator

    Protocol Summary

    Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL .

    OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of a single dose of 3 different formulations of OnabotA X (A, B \& C; each with varying amounts of the standard excipients in the formulation) in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States.

    Participants will receive one dose of OnabotA X administered as 5 injections on Day 1.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Advanced Research Associates - Glendale /ID# 227368
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Skin Research Institute LLC /ID# 227366
    Coral Gables, Florida, United States, 33146-1837
    Status
    Not applicable
    Location
    Etre Cosmetic Dermatology and Laser Center /ID# 227365
    New Orleans, Louisiana, United States, 70130-4353
    Status
    Not applicable
    Location
    The Center for Dermatology Cosmetics & Laser Surgery /ID# 227369
    Mount Kisco, New York, United States, 10549-3028
    Status
    Not applicable
    Location
    Austin Institute for Clinical Research /ID# 227367
    Pflugerville, Texas, United States, 78660
    Status
    Not applicable