Lateral Canthal Lines Clinical Trial
Official title:
Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
| Verified date | December 2013 |
| Source | Anterios Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | October 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 30 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Anterios Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator's Global Assessment Scale | Week 4 | No | |
| Secondary | Subject Self-Assessment | Week 4 | No |
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