A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Lateral Canthal Lines, Crow's Feet, Facial Wrinkles

In brief

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

Key facts

Study ID

NCT01124552

Run by

Revance Therapeutics, Inc.

People needed

180

Starts

2010-04-01

Expected to finish

2010-07-01

Last updated by the study team

2014-01-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
• Previous participation in a RT001 clinical study

Where it is running

• Dermatology Research Institute, LLC — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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