A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Study Identifier
191622-142
CT.gov Identifier
NCT02261467
EudraCT Identifier
2014-001860-36
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • OnabotulinumtoxinA
  • Normal Saline
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe forehead and glabellar lines * Willing to have facial photos taken
    Exclusion Criteria:
    * Prior exposure to botulinum toxin of any serotype for any indication * Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months * Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months * Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year * Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery) * Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation

    Protocol Summary

    This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Center, PC
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Advanced Research Associates
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Clinical Science Institute
    Santa Monica, California, United States, 90404
    Status
    Not applicable
    Location
    About Skin Dermatology and DermSurgery, PC
    Greenwood Village, Colorado, United States, 80111
    Status
    Not applicable
    Location
    Steven Fagien, MD, PA
    Boca Raton, Florida, United States, 33431
    Status
    Not applicable
    Location
    Laser & Skin Surgery Center of Indiana
    Carmel, Indiana, United States, 46032
    Status
    Not applicable
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