NCT02939573

A Randomized Multicenter Study for Isolated Skin Vasculitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients will be initially randomized (1:1:1) to receive one of the 3 medications under investigation (colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint is response to treatment at month 6 (stage 1). If the patient has to discontinue the study drug within the 6 month study period or during the subsequent follow-up period (up to month 12) because of a lack of response (or failure), flare or side effect, he/she will be randomized again to receive one of the remaining two study drugs (stage 2, with a 1:1 randomization ratio) for 6 months. Endpoint in this second stage will again be the response to treatment at 6 months.

Conditions

• Primary Cutaneous Vasculitis
• Cutaneous Polyarteritis Nodosa
• IgA Vasculitis
• Henoch-Schönlein Purpura

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2016-10-20
• Last updated: 2026-01-23

Locations

16 sites across 3 countries: United States, Canada, Japan