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

Phase 2

Completed

• Conditions: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
• Interventions: Drug: RT001; Other: Vehicle Comparator

• Registration Number: NCT00888914
• Lead Sponsor: Revance Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Disposition First Submitted: 2010-09-23
• Disposition First Submitted QC: 2010-09-23
• Disposition First Posted: 2010-09-28
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Female or male; 30 to 55 years of age
• Bilateral lateral canthal lines rated as moderate or advanced
• Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening through End of Study
• Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion Criteria

• Muscle weakness or paralysis in the area receiving study treatment
• Active skin disease or irritation at the treatment areas
• Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
• Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
• Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
• Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose D	RT001	RT001 Dose D; Active Comparator
Dose A	RT001	RT001 Dose A; Active Comparator
Dose B	RT001	RT001 Dose B; Active Comparator
Dose C	RT001	RT001 Dose C; Active Comparator
Dose E	Vehicle Comparator	RT001 Dose E; Vehicle Comparator

Primary Outcome Measures

Name	Time	Method
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28)	Day 28

Secondary Outcome Measures

Name	Time	Method
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28)	Day 28
Incidence of treatment-emergent AEs	Day 28

Trial Locations

Locations (4)

Richard G. Glogau, MD; 🇺🇸 San Francisco, California, United States

Aesthetic Plastic Surgery; 🇺🇸 New York City, New York, United States

Head and Neck Surgical Group; 🇺🇸 New York City, New York, United States

Dermatology Surgery and Laser Center; 🇺🇸 White Plains, New York, United States