Skin Aging Clinical Trial
Verified date | December 2013 |
Source | Revance Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines
Status | Completed |
Enrollment | 82 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Moderate to severe crow's feet lines - Female or male, 18 to 65 years of age and in good general health - Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study Exclusion Criteria: - Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A - Muscle weakness or paralysis, particularly in the area receiving study treatment - Active skin disease or irritation at the treatment area - Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart - Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dermatology Research Institute | Coral Gables | Florida |
Lead Sponsor | Collaborator |
---|---|
Revance Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite endpoint | Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines | Week 4 | No |
Secondary | Investigator Global Assessment with 2 points or greater improvement from baseline | Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 | No |
Secondary | Investigator Global Assessment with 1 point or greater improvement from baseline | Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 | No |
Secondary | Patient Severity Assessment with 2 points or greater improvement from baseline | Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment | Week 4 | No |
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