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

Facial Wrinkles Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, to Treat Moderate to Severe Lateral Canthal Lines in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888914
• Other study ID #: RT001-CL006LCL
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2009
• Last updated: October 25, 2013
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2013
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• RT001
RT001
• RT001
RT001
• RT001
RT001
• RT001
RT001

Other:
• Vehicle Comparator
Vehicle Comparator

Locations

Country	Name	City	State
United States	Aesthetic Plastic Surgery	New York City	New York
United States	Head and Neck Surgical Group	New York City	New York
United States	Richard G. Glogau, MD	San Francisco	California
United States	Dermatology Surgery and Laser Center	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Incidence of treatment-emergent AEs		Day 28	Yes