Status:
COMPLETED
Efficacy and Safety 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
30-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.
Detailed Description
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at leas...
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
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders
- Muscle weakness or paralysis in the area receiving study treatment
- Active skin disease or irritation at the treatment areas
- Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
- Use of prescription retinoid products during the past 3 months prior to Screening
- Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
- Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow lift or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
- Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
- Previous treatment with Botulinum Toxin Type A in the face area
- Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
- Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at 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
- Clinically significant laboratory values at Screening
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00968942
Start Date
August 1 2009
End Date
October 1 2009
Last Update
November 19 2013
Active Locations (1)
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1
Dermatology Research Institute, LLC.
Coral Gables, Florida, United States, 33146