Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

Overview

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.

Full Title of Study: “Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
  • Study Primary Completion Date: August 2003

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

Arms, Groups and Cohorts

  • Other: CsA-ECP
    • Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
  • Other: ECP-CsA
    • Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given

Clinical Trial Outcome Measures

Primary Measures

  • Change of SCORAD (SCORing Atopic Dermatitis)
    • Time Frame: 4 month

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Erik Obitz, MD, DMSc, Principal Investigator, Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

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