NCT00968825

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

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Administration 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: 73 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	RT001 (Botulinum Toxin Type A Topical Gel) Dose D applied topically at Baseline (Day 0) to the lateral canthal lines
DRUG	Placebo	Placebo (Dose E) applied topically at Baseline (Day 0) to the lateral canthal lines

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-08-31
• Last updated: 2013-11-19

Locations

1 site across 1 country: United States