Lateral Canthal Lines Clinical Trial
Official title:
A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment Lateral Canthal Lines in Adults
The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.
This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center
study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single,
bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will
be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and
efficacy of two different doses of RT001, compared to placebo, will be evaluated.
At least 180 adult volunteers who have provided informed consent and have met the study
eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential
cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2
will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the
safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have
reached Day 14 or later with no Study Pause Criteria being observed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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