Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Study Overview
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Brief Summary
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To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.

Official Title
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Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Ciclosporine A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female patients age >= 18 and < 55 weight between 50 and 100 kg confirmed diagnosis of AE (UK working party criteria) objective SCORAD > 40 DLQI > 10 resistancy against topical treatment options including steroids and calcineurin-inhibitors Exclusion Criteria: participation to another clinical trial within the last 4 weeks before baseline pregnant or breastfeeding women of childbearing potential without adequate contraception allergy against prednisolone or Ciclosporine A acute bacterial or viral infection malignant tumor in personal history diabetes mellitus arterial hypertension Glaucoma peptic ulcer severe osteoporosis tuberculosis in personal history colitis ulcerosa diverticulitis concurrent treatment with chloroquin, Mefloquin, Statins, Warafin Creatinin Clearance < 60 ml /min UV treatment within 8 weeks before inclusion ongoing systemic immunosuppressive treatment planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study Poliomyelitis Lymphadenitis after BCG vaccination Hyperuricaemia chronic liver disease Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome Psychiatric co-morbidity drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Prednisolone<br> <br> |
| Active Comparator: 2<br> | Drug: Ciclosporine A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stable remission in both treatment groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate in both treatment groups |  |  | 
| relapse rate in both treatment groups |  |  | 
| mean change in objective SCORAD in both treatment groups |  |  | 
| mean change in HRQL (DLQI) in both treatment groups |  |  | 
| change in disease symptoms (POEM)in both treatment groups |  |  | 
| Cost-effectiveness of both treatments |  |  | 
| Tolerability and Safety |  |  | 
| change in presenteeism in both treatment groups |  |  | 
| patient satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, prednisolone, ciclosporine, SCORAD, DLQI, QALY, WLQ