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Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

NCT02226068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-03-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cyclosporine A (CsA)

3 mg/kg/day for 4 month

OTHER

Extracorporeal photopheresis (ECP)

Administered two consecutive days twice a month for 4 month

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Erik Obitz, MD, DMSc · Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2003-08-31
Completion
2004-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02226068 on ClinicalTrials.gov