A Randomized Multicenter Study for Isolated Skin Vasculitis
NCT02939573 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-01-23
Summary
Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.
Conditions
- Primary Cutaneous Vasculitis
- Cutaneous Polyarteritis Nodosa
- IgA Vasculitis
- Henoch-Schönlein Purpura
Interventions
- DRUG
-
Colchicine
Randomized to colchicine 0.6 mg x 2/day
- DRUG
-
Dapsone
Randomized to dapsone 150 mg/day
- DRUG
-
Azathioprine
Randomized to azathioprine 2 mg/kg/day
Sponsors & Collaborators
-
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
collaborator NIH -
National Center for Advancing Translational Sciences (NCATS)
collaborator NIH -
Office of Rare Diseases (ORD)
collaborator NIH - lead OTHER
Principal Investigators
-
Robert Micheletti, MD · University of Pennsylvania
-
Christian Pagnoux, MD, MPH, MSc · University of Toronto/Mount Sinai Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-01
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- United States
- Canada
- Japan
Study Locations
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