Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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CsA-ECP

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

Group Type OTHER

Cyclosporine A (CsA)

Intervention Type DRUG

3 mg/kg/day for 4 month

Extracorporeal photopheresis (ECP)

Intervention Type OTHER

Administered two consecutive days twice a month for 4 month

ECP-CsA

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

Group Type OTHER

Cyclosporine A (CsA)

Intervention Type DRUG

3 mg/kg/day for 4 month

Extracorporeal photopheresis (ECP)

Intervention Type OTHER

Administered two consecutive days twice a month for 4 month

Interventions

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Cyclosporine A (CsA)

3 mg/kg/day for 4 month

Intervention Type DRUG

Extracorporeal photopheresis (ECP)

Administered two consecutive days twice a month for 4 month

Intervention Type OTHER

Other Intervention Names

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Sandimmune

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No