Skin Aging
Conditions
Brief summary
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
Interventions
DRUGPlacebo
Placebo, Dose B; dose applied to the lateral canthal lines
DRUGBotulinum Toxin Type A
Botulinum Toxin Type A, Dose A, 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 or 3 months anywhere in the body
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint | Week 4 | Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment with 2 points or greater improvement from baseline | Week 4 | Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment |
| Investigator Global Assessment with 1 point or greater improvement from baseline | Week 4 | Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment |
| Patient Severity Assessment with 2 points or greater improvement from baseline | Week 4 | Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment |
Countries
United States
Outcome results
None listed