Dose Finding Study In Subjects With Crow's Feet
Phase 2
Completed
- Conditions
- Lateral Canthal LinesCrow's Feet
- Interventions
- Biological: VehicleBiological: ANT-1401
- Registration Number
- NCT01951742
- Lead Sponsor
- Anterios Inc.
- Brief Summary
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Inclusion Criteria
- 30 - 60 years of age
- mild to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet wrinkles on contraction
- willingness to refrain from any product affecting skin remodeling
- female subjects must be not pregnant and non-lactating
Exclusion Criteria
- history of peri-ocular surgery, brow lift or related procedures
- procedures affecting the lateral canthal region in the prior 12 months
- application of topical prescription medication to the treatment area
- female subjects who are pregnant or are nursing a child
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle vehicle without ANT-1401 Dose 2 ANT-1401 second lowest dose Dose 1 ANT-1401 lowest dose Dose 3 ANT-1401 mid-level dose Dose 4 ANT-1401 second highest dose Dose 5 ANT-1401 highest dose
- Primary Outcome Measures
Name Time Method Investigators Global Assessment Scale Week 4 Crow's Feet Wrinkle Scale
- Secondary Outcome Measures
Name Time Method Subject Self-Assessment score up to 12 12 weeks Subjects self assessment of severity of Crow's Feet