Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

University of Aarhus20 enrolled

Overview

Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Atopic Dermatitis

Interventions

Cyclosporine A (CsA)DRUG

3 mg/kg/day for 4 month

Extracorporeal photopheresis (ECP)OTHER

Administered two consecutive days twice a month for 4 month

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar). Exclusion Criteria: Criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants within 4 weeks prior to start of trial.

Outcomes

Primary Outcomes

Change of SCORAD (SCORing Atopic Dermatitis)

Time frame: 4 month

Data from ClinicalTrials.gov

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