Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

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.

Inclusion criteria

• Female or male; 30 to 55 years of age
• Bilateral lateral canthal lines rated as moderate or advanced
• Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening through End of Study
• Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion criteria

• Muscle weakness or paralysis in the area receiving study treatment
• Active skin disease or irritation at the treatment areas
• Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
• Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
• Use of a 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 (Day 28)
• Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure