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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Revance Therapeutics, Inc.
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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