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

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

The purpose of this study is to evaluate the efficacy and safety of a single administration of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal lines.

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles; Lateral Canthal Lines; Crow's Feet
• Intervention / Treatment: Drug: Botulinum Toxin Type A; Drug: Placebo

Detailed Description

This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the efficacy and safety of a single administration of RT001 compared to placebo applied as a bilateral application in at least 72 subjects with moderate to severe Lateral Canthal Lines. Subjects will be randomized within each site to 1 of 2 treatment groups in a 1:1 ratio. The efficacy and safety of RT001 compared to placebo will be evaluated. Study follow-up visits will occur at Weeks 2, 4 and 6.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94117
      • RGG, Inc

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 based on the Investigator Global Assessment - Lateral Canthal Lines Rest and Investigator Global Assessment - Lateral Canthal Lines Smile Severity Scales
• 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 (Week 6)
• 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:

• Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and euromuscular junctional disorders
• Muscle weakness or paralysis in the area receiving study treatment
• Active skin disease or irritation at the treatment areas
• Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
• Use of prescription retinoid products during the past 3 months prior to Screening
• Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
• Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow left or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
• Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
• Previous treatment with Botulinum Toxin Type A in the face area
• Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
• Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at 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 (Week 6)
• Clinically significant laboratory values at Screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dose D; RT001	Drug: Botulinum Toxin Type A; RT001 (Botulinum Toxin Type A Topical Gel) Dose D applied topically at Baseline (Day 0) to the lateral canthal lines
Placebo Comparator: Dose E; Placebo	Drug: Placebo; Placebo (Dose E) applied topically at Baseline (Day 0) to the lateral canthal lines

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 of Lateral Canthal Line Severity at Rest from Baseline (Day 0) to Week 4; incidence of treatment emergent AEs	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest and Smile from Baseline (Day 0) to Week 4 and Baseline (Day 0) to Week 6; incidence of treatment emergent AEs	Week 4 and Week 6

Collaborators and Investigators

• Sponsor: Revance Therapeutics, Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 28, 2009
• First Posted (Estimate): August 31, 2009

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Lateral Canthal Lines; Facial Wrinkles; Crow's Feet
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: RT001-CL012LCL