Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Completed · Phase 2
Conditions studied: Lateral Canthal Lines, Crow's Feet, Facial Wrinkles
In brief
This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.
Key facts
- Study ID
- NCT01124565
- Run by
- Revance Therapeutics, Inc.
- People needed
- 40
- Starts
- 2010-05-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2014-01-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Written informed consent including authorization to release health information
- Female or male, 18 to 65 years of age and in good general health
- Willing and able to follow study instructions and likely to complete all study requirements
- Moderate to severe lateral canthal lines (crow's feet wrinkles)
You may not qualify if…
- 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 such as Lambert-Eaton syndrome and myasthenia gravis
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active disease or irritation at the treatment areas including the eye and the skin
- Pregnant, nursing, or planning a pregnancy during the study; or is a woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- Previous participation in a RT001 clinical study
- Previous treatment with botulinum toxin (any serotype)
Where it is running
- Total Skin & Beauty Dermatology Center, PC — Birmingham, Alabama, United States
- Therapeutics Clinical Research — San Diego, California, United States
- Skin Specialists, PC — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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