A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides

Study Identifier
191622-143
CT.gov Identifier
NCT02261493
EudraCT Identifier
2014-001815-38
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
  • Normal Saline
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe forehead lines, glabellar lines, and crow's feet 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 upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines \[crow's feet lines\]).

    Study Locations

    Location
    Status
    Location
    The Petrus Center for Aesthetic
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Westside Aesthetics
    Los Angeles, California, United States, 90025
    Status
    Not applicable
    Location
    Eye Research Foundation
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Steve Yoelin, MD Medical Associates, Inc.
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Baumann Cosmetic & Research Institute
    Miami, Florida, United States, 33137
    Status
    Not applicable
    Location
    Saint Louis University
    St Louis, Missouri, United States, 63122
    Status
    Not applicable
    Showing {first} - {last} of {total} Results