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, for the Treatment Lateral Canthal Lines in Adults

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines
• Intervention / Treatment: Drug: RT001; Drug: RT001; Other: Placebo

Detailed Description

This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.

At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin & Beauty Dermatology Center
  • California
    • San Francisco, California, United States, 94117
      • Richard G. Glogau, Inc.
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Dermatology Research Institute, LLC
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New York
    • New York City, New York, United States, 10019
      • Head and Neck Surgical Group
    • New York City, New York, United States, 10065
      • Aesthetic Plastic Surgery
    • White Plains, New York, United States, 10604
      • Dermatology Surgery and Laser Center
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce & Associates / The Center for Skin Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female or male, 30 to 60 years of age
• Bilateral lateral canthal lines rated as moderate or severe
• Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and 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
• 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.
• Previous treatment with Botulinum Toxin Type A in the face area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dose A; Dose A RT001	Drug: RT001; Dose A RT001; Drug: RT001; Dose B RT001
Active Comparator: Dose B; Dose B RT001	Drug: RT001; Dose A RT001; Drug: RT001; Dose B RT001
Placebo Comparator: Dose C; Dose C Placebo	Other: Placebo; Dose C Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28	Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events	Day 28

Collaborators and Investigators

• Sponsor: Revance Therapeutics, Inc.
• Investigators: Study Director: Debbie Tranowski, Revance Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: May 20, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Lateral Canthal Lines; Facial Wrinkles; Crow's Feet
• Other Study ID Numbers: RT001-CL010LCL