Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

University of Aarhus

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Extracorporeal photopheresis (ECP); Drug: Cyclosporine A (CsA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02226068

CsAvsECP-AUH

CsA-ECP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

CsA-ECP

Other group

Description:

Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given

Treatment:

Drug: Cyclosporine A (CsA)

Other: Extracorporeal photopheresis (ECP)

ECP-CsA

Other group

Description:

Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given

Treatment:

Drug: Cyclosporine A (CsA)

Other: Extracorporeal photopheresis (ECP)