NCT00884234

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

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Lateral Canthal Lines

Interventions

Type	Name	Description
OTHER	Vehicle Control	Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
DRUG	RT001 (Botulinum Toxin Type A Topical Gel)	Two sequential doses of RT001 at Baseline (Day 0) and Week 2

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2009-04-20
• Last updated: 2020-08-28

Locations

1 site across 1 country: United States