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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
Two sequential doses of RT001 at Baseline (Day 0) and Week 2
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, United States
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
Time frame: Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Time frame: Baseline (Day 0) and Week 6
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