NCT01124552

A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Revance Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

Detailed description

RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Conditions

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

Interventions

Type	Name	Description
DRUG	RT001 Botulinum toxin type A (Dose A)	RT001 Botulinum Toxin Type A (Dose A)
DRUG	RT001 Botulinum Toxin Type A (Dose B)	RT001 Botulinum Toxin Type A (Dose B)
OTHER	Vehicle	Vehicle Control
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-05-17
• Last updated: 2014-01-30

Locations

1 site across 1 country: United States