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

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.

Sponsors

Lead Sponsor: Revance Therapeutics, Inc.

Source 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.

Overall Status Completed
Start Date November 2008
Completion Date February 2009
Primary Completion Date January 2009
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: RT001

Description: RT001

Arm Group Label: Dose B

Intervention Type: Drug

Intervention Name: RT001

Description: RT001

Arm Group Label: Dose A

Intervention Type: Drug

Intervention Name: RT001

Description: RT001

Arm Group Label: Dose C

Intervention Type: Drug

Intervention Name: RT001

Description: RT001

Arm Group Label: Dose D

Intervention Type: Other

Intervention Name: Vehicle Comparator

Description: Vehicle Comparator

Arm Group Label: Dose E

Eligibility

Criteria:

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

Gender: All

Minimum Age: 30 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Location
Facility:
Richard G. Glogau, MD | San Francisco, California, 94117, United States
Head and Neck Surgical Group | New York City, New York, 10019, United States
Aesthetic Plastic Surgery | New York City, New York, 10065, United States
Dermatology Surgery and Laser Center | White Plains, New York, 10604, United States
Location Countries

United States

Verification Date

October 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 5
Arm Group

Label: Dose A

Type: Active Comparator

Description: RT001 Dose A; Active Comparator

Label: Dose B

Type: Active Comparator

Description: RT001 Dose B; Active Comparator

Label: Dose C

Type: Active Comparator

Description: RT001 Dose C; Active Comparator

Label: Dose D

Type: Active Comparator

Description: RT001 Dose D; Active Comparator

Label: Dose E

Type: Placebo Comparator

Description: RT001 Dose E; Vehicle Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov