Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Completed · Phase 2 · Has a placebo group
Conditions studied: Lateral Canthal Lines
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 and duration of effect.
Key facts
- Study ID
- NCT00907387
- Run by
- Revance Therapeutics, Inc.
- People needed
- 72
- Starts
- 2009-04-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2014-01-17
Who can join
Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Female or male, 30 to 60 years of age
- Bilateral lateral canthal lines rated as moderate or severe
- Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and 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
- 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.
- Previous treatment with Botulinum Toxin Type A in the face area
Where it is running
- Total Skin & Beauty Dermatology Center — Birmingham, Alabama, United States
- Richard G. Glogau, Inc. — San Francisco, California, United States
- Dermatology Research Institute, LLC — Coral Gables, Florida, United States
- SkinCare Physicians, Inc. — Chestnut Hill, Massachusetts, United States
- Skin Specialists, PC — Omaha, Nebraska, 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
- Suzanne Bruce & Associates / The Center for Skin Research — Houston, Texas, United States
Full record on ClinicalTrials.gov
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