Status:
COMPLETED
Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Lead Sponsor:
Technische Universität Dresden
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00445081
Start Date
March 1 2007
End Date
January 1 2010
Last Update
October 29 2010
Active Locations (5)
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1
University Hospital of Dermatology and Venerology Graz
Graz, Austria, 8036
2
Dept. of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany, 01307
3
Dpt. of Dermatology, Medical Faculty Eppendorf
Hamburg, Germany, 20246
4
University Hospital Kiel
Kiel, Germany, 24105