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

NCT ID: NCT00968942

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2009-10-31

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

Detailed Description

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

Conditions

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

Keywords

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dose A

RT001

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Dose B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Interventions

Botulinum Toxin Type A

RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Intervention Type: DRUG

Placebo

Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Intervention Type: DRUG

Eligibility Criteria

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

• 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 neuromuscular 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 lift 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
• Clinically significant laboratory values at Screening

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Revance Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic S Brandt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dermatology Research Institute, LLC.

Locations

Dermatology Research Institute, LLC.

Coral Gables, Florida, United States

Countries

United States

Other Identifiers

RT001-CL015LCL

Identifier Type: -

Identifier Source: org_study_id