Skin Aging Clinical Trial
Verified date | April 2014 |
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 evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.
Status | Terminated |
Enrollment | 311 |
Est. completion date | December 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Moderate to severe crow's feet lines - Female or male, 18 years of age and above and in good general health - Women of childbearing potential 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 3 months - Chemical peel during the 9 months prior to treatment - Use of prescription retinoid products during the 3 months prior to treatment |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Nashville Centre for Laser and Facial Surgery | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Revance Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments | Up to 24 months | Yes | |
Primary | Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments | Up to 24 months | Yes |
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