Back to resultsPhotophoresis Versus Ciclosporine in Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cyclosporine A (CsA)
Extracorporeal photopheresis (ECP)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Ciclosporine, Extracorporal photopheresis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CsA-ECP
ECP-CsA
Arm Description
Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
Outcomes
Primary Outcome Measures
Change of SCORAD (SCORing Atopic Dermatitis)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02226068
Brief Title
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Ciclosporine, Extracorporal photopheresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CsA-ECP
Arm Type
Other
Arm Description
Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
Arm Title
ECP-CsA
Arm Type
Other
Arm Description
Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A (CsA)
Other Intervention Name(s)
Sandimmune
Intervention Description
3 mg/kg/day for 4 month
Intervention Type
Other
Intervention Name(s)
Extracorporeal photopheresis (ECP)
Intervention Description
Administered two consecutive days twice a month for 4 month
Primary Outcome Measure Information:
Title
Change of SCORAD (SCORing Atopic Dermatitis)
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Obitz, MD, DMSc
Organizational Affiliation
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis
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