A single-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Dapsone in adult patients with cutaneous leukocytoclastic vasculitis - Placebo-controlled trial evaluating Dapsone for the treatment of leukocytoklastic vasculitis

• Conditions: 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

• Registration Number: EUCTR2005-001245-41-AT
• Lead Sponsor: Department of Dermatology, Hospital of the Medical University Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-19
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 62

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:

oHemoglobin> 10 g/dl
oMet-Hb< 5% prior to dapsone therapy
oLeucocytes> 6 G/l
o Serum Creatinine< 1,5 mg/dl
oGOT< 50 U/l
oGPT< 65 U/l
oTotal Bilirubin< 1.5 mg/dl
oThrombocytes> 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

·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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified