NCT01809964CompletedPhase 2
Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Anterios Inc.
- Enrollment
- 109
- Locations
- 7
- Primary Endpoint
- Investigator's Global Assessment Scale
Study Overview
Brief Summary
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Dose 2
Experimental
ANT-1401
Intervention: ANT-1401 (Biological)
Dose 1
Experimental
ANT-1401
Intervention: ANT-1401 (Biological)
Vehicle
Placebo Comparator
Placebo Vehicle
Intervention: Vehicle (Biological)
Outcomes
Primary Outcomes
Investigator's Global Assessment Scale
Time Frame: Week 4
Secondary Outcomes
- Subject Self-Assessment(Week 4)
Investigators
Study Sites (7)
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