Skin Aging
Conditions
Brief summary
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.
Interventions
DRUGBotulinum Toxin Type A
Botulinum toxin type A, Dose A applied to the lateral canthal area
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed