BOTOX® in the Treatment of Crow's Feet Lines in Japan
ClinicalTrials.gov ID
NCT01797081
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
300Actual
Last Update Posted
Apr 16, 2019Actual
Start Date
Jan 31, 2013Actual
Primary Completion Date
Jul 18, 2013Actual
Completion Date
Jul 7, 2014Actual
Brief Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
Lateral Canthus Rhytides
Crow's Feet Lines
botulinum toxin Type A (24 U)
botulinum toxin Type A (12 U)
Normal Saline
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Moderate to severe Crow's Feet Lines
Exclusion Criteria:
Current or previous botulinum toxin treatment of any serotype
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
Medium-depth or deep facial peels within 5 years
Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)