Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Revance Therapeutics, Inc.90 enrolled

Overview

The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.

RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lateral Canthal Lines Crow's Feet Facial Wrinkles

Interventions

Botulinum Toxin Type ADRUG

RT001 (Botulinum Toxin Type A Topical Gel, Dose A) applied topically at Baseline (Day 0) to the lateral canthal lines

Placebo (Dose B)DRUG

Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent including authorization to release health information * Female or male, 18 to 65 years of age and in good general health * Willing and able to follow study instructions and likely to complete all study requirements * Moderate to severe lateral canthal lines (crow's feet wrinkles) 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 such as Lambert-Eaton syndrome and myasthenia gravis * Muscle weakness or paralysis, particularly in the area receiving study treatment * Active disease or irritation at the treatment areas including the eye and the skin * Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control * Previous participation in a RT001 clinical study

Locations (1)

Dermatology Research Institute, LLC

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

The number of subjects who show improvement based on the investigator global and patient assessments.

Time frame: Week 4

Secondary Outcomes

The number of subjects who show improvement based on the investigator global and patient assessments.

Time frame: Week 8

Data from ClinicalTrials.gov

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