Status:
COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lead Sponsor:
Revance Therapeutics, Inc.
Conditions:
Lateral Canthal Lines
Crow's Feet
Eligibility:
All Genders
30-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.
Detailed Description
This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00888914
Start Date
November 1 2008
End Date
February 1 2009
Last Update
November 19 2013
Active Locations (4)
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1
Richard G. Glogau, MD
San Francisco, California, United States, 94117
2
Head and Neck Surgical Group
New York, New York, United States, 10019
3
Aesthetic Plastic Surgery
New York, New York, United States, 10065
4
Dermatology Surgery and Laser Center
White Plains, New York, United States, 10604