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: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

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

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

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

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

Jochen M Schmitt, MD MPH Principal Investigator Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden  

Overall Contact: Jochen M Schmitt, MD, MPH 0049 351 458 Jochen.Schmitt@uniklinikum-dresden.de

Information obtained from ClinicalTrials.gov on July 02, 2009

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