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

Completed · Phase 2

Conditions studied: Lateral Canthal Lines

In brief

The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.

Key facts

Study ID

NCT00884234

Run by

Revance Therapeutics, Inc.

People needed

30

Starts

2009-02-01

Expected to finish

2009-06-01

Last updated by the study team

2020-08-28

Who can join

Age: 30 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Female/male ages 30 to 55
• Bilateral lateral canthal lines rated as moderate or advanced.
• Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
• Women of child baring potential must practice and be willing to continue to use an effective method of birth control.

You may not qualify if…

• Muscle weakness or paralysis in the area receiving treatment.
• Active skin disease or irritation at 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 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 (Week 6).
• Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.

Where it is running

• Suzanne Bruce & Associates / The Center for Skin Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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