Prednisolone vs. Ciclosporine in Severe Atopic Eczema
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
Status: Completed (Phase 4). Started on March 1st, 2007.
Enrollment: 66 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Investigator)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: Prednisolone
- Drug: Ciclosporine A
Eligibility
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
peptic ulcer
severe osteoporosis
tuberculosis in personal history
colitis ulcerosa
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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
55 Years
- Healthy Volunteers
No
Resources
Source: Dresden University of Technology
Authority: Germany: Federal Institute for Drugs and Medical Devices
Locations
-
University Hospital of Dermatology and Venerology Graz
Graz
8036
Austria
-
Dept. of Dermatology, Medical Faculty, TU Dresden
Dresden
01307
Germany
-
Dpt. of Dermatology, Medical Faculty Eppendorf
Hamburg
20246
Germany
-
University Hospital Kiel
Kiel
24105
Germany
-
Dpt. of Dermatology, University Hospital M��nster
M��nster
48149
Germany
Officials
Jochen M Schmitt, MD MPH (Principal Investigator, Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden)
Sponsors
Dresden University of Technology (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- October 1st, 2010
- First Received
- October 28th, 2010
- Last Changed
- October 28th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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