Lateral Canthal Lines Clinical Trial
Official title:
Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
| Verified date | May 2014 |
| 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 establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
| Status | Completed |
| Enrollment | 145 |
| Est. completion date | January 2014 |
| Est. primary completion date | December 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 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 |
Allocation: Randomized, Endpoint Classification: Safety/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 | Investigators Global Assessment Scale | Crow's Feet Wrinkle Scale | Week 4 | No |
| Secondary | Subject Self-Assessment score | Subjects self assessment of severity of Crow's Feet | up to 12 12 weeks | No |
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