Lateral Canthal Lines
Conditions
Keywords
Lateral Canthal Lines, Crow's Feet, Facial Wrinkles, Lateral Canthal Area
Brief summary
The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
Detailed description
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).
Interventions
OTHERVehicle Control
Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
DRUGRT001 (Botulinum Toxin Type A Topical Gel)
Two sequential doses of RT001 at Baseline (Day 0) and Week 2
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female/male ages 30 to 55 2. Bilateral lateral canthal lines rated as moderate or advanced. 3. Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6. 4. Women of child baring potential must practice and be willing to continue to use an effective method of birth control.
Exclusion criteria
1. Muscle weakness or paralysis in the area receiving treatment. 2. Active skin disease or irritation at treatment areas. 3. Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening. 4. Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0). 5. Use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through End of Study (Week 6). 6. Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6). | Baseline (Day 0) and Week 6 |
| Incidence of treatment emergent AEs. | Baseline (Day 0) and Week 6 |
Countries
United States
Outcome results
None listed