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

Completed · Phase 2

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

In brief

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

Key facts

Study ID

NCT00888914

Run by

Revance Therapeutics, Inc.

People needed

60

Starts

2008-11-01

Expected to finish

2009-02-01

Last updated by the study team

2013-11-19

Who can join

Age: 30 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male; 30 to 55 years of age
• Bilateral lateral canthal lines rated as moderate or advanced
• Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening 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

You may not qualify if…

• Muscle weakness or paralysis in the area receiving study treatment
• Active skin disease or irritation at the treatment areas
• Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
• Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
• 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 (Day 28)
• Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure

Where it is running

• Richard G. Glogau, MD — San Francisco, California, United States
• Head and Neck Surgical Group — New York, New York, United States
• Aesthetic Plastic Surgery — New York, New York, United States
• Dermatology Surgery and Laser Center — White Plains, New York, United States

Full record on ClinicalTrials.gov

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