Prednisolone vs. Ciclosporine in Severe Atopic Eczema
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis...
Brief Summary
Official Title: “Prednisolone vs. Ciclosporine in Severe Atopic Eczema”
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: September 2009
Intervention(s) in this Clinical Trial
- Drug: Prednisolone
- Drug: Ciclosporine A
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- stable remission in both treatment groups
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Dresden University of Technology Other
Overall Clinical Trial Officials and Contacts
Jochen M Schmitt, MD MPH Principal Investigator Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00445081
Study ID Number: TUD_PROVE_001
ClinicalTrials.gov Identifier: NCT00445081
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00445081
