Cutaneous leukocytoclastic vasculitis is an inflammatory vascular disease and is manifested clinically by a spectrum of cutaneous lesions, although “papable purpura” is its clinical hallmark. The pathogenetic role of the deposition of immune complexes and complement in the vessel wall and the subsequent recruitment of polymorphonuclear leukocytes that mediate tissue injury have been shown. Dapsone (4,4´- diaminodiphenylsulfone, DDS) may inhibit this pathogenetic mechanism
Conditions
Interventions
Trade Name: Dapsone
Product Name: Dapsone/Diaminodiphenylsulfone
Pharmaceutical Form: Capsule*
INN or Proposed INN: Dapsone
CAS Number: 80-08-8
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Department of Dermatology, Hospital of the Medical University Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria To be eligible for the study, subjects must meet all of the following criteria: ·Must be 18 years or older at time of enrolment; may be female or male ·Have had a diagnosis of cutaneous leukocytoclastic vasculitis (CLV) at least one month prior to screening ·Positive histologic and/or direct immunofluorescence findings ·Are candidates for systemic therapy of CLV (previous medication must be discontinued 2 weeks prior to baseline visit). ·Women of childbearing potential have to undergo a urine pregnancy test continously and must be using adequate birth control measures (eg. abstinence, oral contraceptives, intrauterine device) during dapsone therapy. ·Must be able to adhere to the study visit schedule and other protocol requirements ·Must be capable of giving informed consent and the consent must be obtained prior to any study related procedures ·Must have screening laboratory test results within the following parameters: o Hemoglobin > 10 g/dl o Met-Hb 6 G/l o Serum Creatinine 144 G/l Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria ·Subjects who meet any of following criteria may not be enrolled in the study: ·CLV with significant systemic manifestation and/or severe necrotizing and ulzerating cutaneous vasculitis. ·Patients with CLV of less than one month´s duration ·Have a history of any clinically significant hypersensitivity reaction/adverse reation to sulfonamides ·Patients with glucose-6-phosphate dehydrogenase, glutathione reductase or methemoglobin reductase deficieny ·Have current signs or symptoms of severe progressive, or uncontrolled renal (Creatinine Clearance<25ml/min, proteinuria, hematuria), hepatic, haematological, gastrointestinal, pulmonary, cardiac, neurologic, cerebral or psychiatric disease ·Thyroid dysfunction ( hypothyroidism ) ·Pregnancy and lactation period ·Are participating in another trial using an investigational agent or procedure during participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective To determine the efficacy of a one-month administered therapy with dapsone (1,5mg/kg) compared to placebo in subjects with cutaneous leucocytoclastic vasculitis ;Secondary Objective: ·To determine the efficacy of a two-month administered maintenance therapy with dapsone (1,5mg/kg) compared to placebo in subjects with cutaneous leucocytoclastic vasculitis ·To assess the rate of complete response at weeks 4 and 12 ·To assess the durability of response after maintenance therapy at weeks 16, 24 and 36 ·To assess the rate of IgA-mediated vasculitis ·To determine the efficacy of dapsone in the different subtypes of chronic cutaneous leukocytoclastic vasculitis ·To assess the safety of dapsone therapy ·To assess the effects of dapsone on quality of life ;Primary end point(s): The primary endpoint for the study is the proportion of subjects who are marked responders to week 4. (Proportion of subjects achieving a >75% improvement in CLV from baseline at week 4, measured primarily by the number of cutaneous lesions per traget lesion; "target lesion" means an area of 9 cm2, being defined at screening period and showing most cutaneous involvment [number of purpura patches and papules will be ssessed]). | — |
Countries
Austria
Outcome results
None listed