Institution: Dermatology and Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
Title: A randomized multicenter study for isolated skin vasculitis (ARAMIS)
Award: $50,479, one-year
Vasculitis is a rare disease that damages blood vessels. When it affects the skin, it causes multiple burning or itchy purple spots which can become painful ulcers or become infected. For patients who get such lesions recurrently, vasculitis of the skin can be debilitating.
Unfortunately, we do not know what medications work best for this condition. There have not been any studies which address this question adequately. Therefore, doctors often try various medications at different doses before hitting on an effective regimen.
ARAMIS is a trial specifically for chronic, recurrent skin vasculitis which will test three medications—dapsone, colchicine, and azathioprine—used commonly but never proven to work for that condition. Patients will receive one of the three medications titrated to a goal dose and duration designed to evaluate its effectiveness. If the medication does not help after 3-6 months, patients will be switched to one of the other two medications, and the process will be repeated. The primary end point will be significant improvement or complete resolution of skin vasculitis after six (6) months on a particular medication.
The results from these two study stages will be combined to determine which medication is best at decreasing skin lesions and improving patient symptoms. If the study is successful, doctors will for the first time have high-quality scientific evidence to guide how they treat skin vasculitis.
Because skin vasculitis is uncommon and understudied, it truly represents an area of unmet need. With the administrative support of the Vasculitis Clinical Research Consortium (VCRC), we have assembled a multicenter, interdisciplinary team of collaborating rheumatologists and dermatologists to help answer this question, without whom this work would not be possible.
Watch an interview with Dr. Micheletti and Ben Wilson.