NCT00968942

Efficacy and Safety 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 Efficacy and Safety 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: 36 (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 safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

Detailed description

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

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 A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
DRUG	Placebo	Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Timeline

• Start date: 2009-08-01
• 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