Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

Study Identifier
GMA-BTXC-11-001
CT.gov Identifier
NCT01391312
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 - Toxins
    • Study Drug
  • botulinum toxin Type A
  • normal saline (placebo)
    • Phase
    Phase 4
    Sex
    Female
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe glabellar wrinkles (frown lines)
    Exclusion Criteria:
    * Previous treatment with botulinum toxin therapy of any serotype * Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months * Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months * Mid-facial or periorbital treatment with non-permanent soft tissue fillers * Subjects planning a facial cosmetic procedure or visible scars * Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) * Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * History of facial nerve palsy * A planned extended absence during the study

    Protocol Summary

    This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

    Study Locations

    Location
    Status
    Location
    East Chicago, Illinois, United States
    Status
    Not applicable