The purpose of this study is to evaluate the efficacy and safety of a single administration of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal lines.
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the efficacy and safety of a single administration of RT001 compared to placebo applied as a bilateral application in at least 72 subjects with moderate to severe Lateral Canthal Lines. Subjects will be randomized within each site to 1 of 2 treatment groups in a 1:1 ratio. The efficacy and safety of RT001 compared to placebo will be evaluated. Study follow-up visits will occur at Weeks 2, 4 and 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
RT001 (Botulinum Toxin Type A Topical Gel) Dose D applied topically at Baseline (Day 0) to the lateral canthal lines
Placebo (Dose E) applied topically at Baseline (Day 0) to the lateral canthal lines
RGG, Inc
San Francisco, California, United States
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest from Baseline (Day 0) to Week 4; incidence of treatment emergent AEs
Time frame: Week 4
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest and Smile from Baseline (Day 0) to Week 4 and Baseline (Day 0) to Week 6; incidence of treatment emergent AEs
Time frame: Week 4 and Week 6
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