Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Cyclosporine A (CsA); Other: Extracorporeal photopheresis (ECP)

• Registration Number: NCT02226068
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2003-08
• Study Completion: 2004-01
• Status Verified: 2014-08
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-26
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ECP-CsA	Cyclosporine A (CsA)	Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
CsA-ECP	Extracorporeal photopheresis (ECP)	Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
ECP-CsA	Extracorporeal photopheresis (ECP)	Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
CsA-ECP	Cyclosporine A (CsA)	Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given

Primary Outcome Measures

Name	Time	Method
Change of SCORAD (SCORing Atopic Dermatitis)	4 month