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
Eligibility:
All Genders
30-60 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 and duration of effect.
Detailed Description
This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral applica...
Eligibility Criteria
Inclusion
- 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
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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00907387
Start Date
April 1 2009
End Date
October 1 2009
Last Update
January 17 2014
Active Locations (9)
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1
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
2
Richard G. Glogau, Inc.
San Francisco, California, United States, 94117
3
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
4
SkinCare Physicians, Inc.
Chestnut Hill, Massachusetts, United States, 02467