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NCT02226068 Clinical Trial

Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02226068
Other study ID # CsAvsECP-AUH
Secondary ID CsA-ECP
Status Completed
Phase N/A
First received August 25, 2014
Last updated March 26, 2015
Start date June 2002
Est. completion date January 2004

Study information
Verified date August 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2004
Est. primary completion date August 2003
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Outcome
Type Measure Description Time frame Safety issue
Primary Change of SCORAD (SCORing Atopic Dermatitis) 4 month No
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