Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

Study Identifier
191622-099
CT.gov Identifier
NCT01189760
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
  • Facial Aesthetics - Toxins
    • Study Drug
  • onabotulinumtoxinA 24 U
  • onabotulinumtoxinA 44 U
  • normal saline
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe Crow's Feet Lines and Frown Lines * Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)
    Exclusion Criteria:
    * Current or previous botulinum toxin treatment of any serotype * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis * Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) * Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months * Oral retinoid therapy within one year

    Protocol Summary

    This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

    Study Locations

    Location
    Status
    Location
    Newport Beach, California, United States
    Status
    Not applicable
    Location
    Vancouver, British Columbia, Canada
    Status
    Not applicable
    Location
    Antibes, France
    Status
    Not applicable
    Location
    Berlin, Germany
    Status
    Not applicable