Skin Aging
Conditions
Keywords
REALISE 1
Brief summary
This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.
Interventions
BIOLOGICALBotulinum toxin type A
Topical botulinum toxin type A
BIOLOGICALPlacebo comparator
Topical placebo comparator
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
* In good general health * Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment * Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity
Exclusion criteria
* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis * Muscle weakness or paralysis, particularly in the area receiving study treatment * Active skin disease or irritation or disrupted barrier at the treatment area * Active eye disease or irritation * Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart * Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening * Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening * Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines | Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment with 2 points or greater improvement from baseline | Week 4 | Proportion of subjects with 2 points 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 |
| Patient Severity Assessment with 1 points or greater improvement from baseline | Week 4 | Proportion of subjects with a 1 point or greater improvement from baseline using the Patient Severity Assessment |
Countries
United States
Outcome results
None listed