The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.
This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Richard G. Glogau, MD
San Francisco, California, United States
Head and Neck Surgical Group
New York, New York, United States
Aesthetic Plastic Surgery
New York, New York, United States
Dermatology Surgery and Laser Center
White Plains, New York, United States
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28)
Time frame: Day 28
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28)
Time frame: Day 28
Incidence of treatment-emergent AEs
Time frame: Day 28
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RT001
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