Skin Aging
Conditions
Brief summary
This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.
Interventions
DRUGBotulinum Toxin Type A
Botulinum Toxin Type A, Dose A; dose applied to the lateral canthal lines
DRUGPlacebo
Placebo, Dose B; dose applied to the lateral canthal lines
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 |
| Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 |
| Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment | Week 4 |
Countries
United States
Outcome results
None listed