skin vasculitis
Conditions
Interventions
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 subsequen
Sponsors
St. Marianna University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy. 2. The diagnosis of vasculitis must have been confirmed by skin biopsy prior to enrollment (earlier, at diagnosis, and/or just prior to enrollment) that has included an immunofluorescence study (in the case of small vessel vasculitis). 3. Patients must have active cutaneous vasculitis lasting for at least 1 month continuously and/or have had 2 or more flares over the six months preceding enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis). 4. Patients must have active / ongoing cutaneous vasculitis lesions at the time of enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis). 5. Patients may have a contra-indication to one of the study drug or have been treated prior to enrollment with one of the study medications but failed to respond to it (according to the study definitions of failure and if they have been on the drug at the target dose or higher for 3 months or longer) or had to stop it because of an adverse event. Such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of such patients enrolled directly in stage 2 will be capped at 10 (10% of the total recruitment target). 6. Patients may have received systemic glucocorticoids for their cutaneous vasculitis before enrollment.
Exclusion criteria
Exclusion criteria: 1. Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition. 2. Known systemic and/or non-skin-isolated vasculitis. 3. Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides. 4. History of significant intolerance, allergy or serious adverse events to any of the study medications: such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of patients enrolled directly in stage 2 of the study will be capped at 10. 5. Patients who have contra-indications to two or three of the study drugs (azathioprine, colchicine, or dapsone), or have been treated prior to enrollment with two or three of the study drugs but failed to respond to them, or had to stop two or three of them because of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with a response to therapy at month 6 of the pooled study stages 1 and 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patient with complete response to therapy at months 3, 6 and 12 Proportion of patient with significant response to therapy at months 3, 6 and 12 Time to achieve complete or significant response | — |
Countries
Japan,North America
Contacts
Public ContactKawakami Tamihiro
St. Marianna University, School of Medicine Dermatology
Outcome results
None listed