NCT00888914

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

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, to Treat Moderate to Severe Lateral Canthal Lines in Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

Detailed description

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.

Conditions

• Lateral Canthal Lines
• Crow's Feet
• Facial Wrinkles

Interventions

Type	Name	Description
DRUG	RT001	RT001
DRUG	RT001	RT001
DRUG	RT001	RT001
DRUG	RT001	RT001
OTHER	Vehicle Comparator	Vehicle Comparator

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2009-04-28
• Last updated: 2013-11-19

Locations

4 sites across 1 country: United States