Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
ClinicalTrials.gov ID
NCT01189760
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
917Actual
Last Update Posted
Apr 16, 2019Actual
Start Date
Sep 1, 2010Actual
Primary Completion Date
Mar 1, 2011Actual
Completion Date
Sep 1, 2011Actual
Brief 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)
Facial Rhytides
Crow's Feet Lines
Glabellar Lines
onabotulinumtoxinA 24 U
onabotulinumtoxinA 44 U
normal saline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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