Clinical Trial to Evaluate ANT-1401 in Crow's Feet
Phase 2
Completed
- Conditions
- Crows FeetLateral Canthal Lines
- Interventions
- Biological: ANT-1401Biological: Vehicle
- Registration Number
- NCT01809964
- Lead Sponsor
- Anterios Inc.
- Brief Summary
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Inclusion Criteria
- 30 - 60 years of age
- mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest
- moderate to severe Crow's Feet (IGA 2-3) on contraction
- moderate to severe Crow's Feet (SSA 2-3) on contraction
- Have adequate vision to assess facial wrinkles in a mirror
Exclusion Criteria
- botulinum toxin treatment in the prior 6 months
- history of periocular surgery, brow lift or related procedures
- soft tissue augmentation in the lateral canthal region in the prior 12 months
- dermabrasion or laser treatment in the periocular region in the last 6 months
- topical prescription-strength retinoids in the prior 3 months
- present or history of neuromuscular disease
- present or history of "dry eye"
- systemic aminoglycoside use in the week prior to treatment application
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 2 ANT-1401 ANT-1401 Vehicle Vehicle Placebo Vehicle Dose 1 ANT-1401 ANT-1401
- Primary Outcome Measures
Name Time Method Investigator's Global Assessment Scale Week 4
- Secondary Outcome Measures
Name Time Method Subject Self-Assessment Week 4