Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: Prednisolone (Drug); Ciclosporine A (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s):
Jochen M Schmitt, MD MPH, Principal Investigator, Affiliation: Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden
Overall contact:
Jochen M Schmitt, MD, MPH, Phone: 0049 351 458, Ext: 2421, Email: Jochen.Schmitt@uniklinikum-dresden.de
Summary
To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients
with severe atopic dermatitis.
Clinical Details
Official title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: stable remission in both treatment groups
Secondary outcome: response rate in both treatment groupsrelapse 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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jochen M Schmitt, MD, MPH, Phone: 0049 351 458, Ext: 2421, Email: Jochen.Schmitt@uniklinikum-dresden.de
University Hospital of Dermatology and Venerology Graz, Graz 8036, Austria; Recruiting
Werner Aberer, Prof., MD
Werner Aberer, Prof., MD, Principal Investigator
Christian Schuster, MD, Sub-Investigator
Dept. of Dermatology, Medical Faculty, TU Dresden, Dresden 01307, Germany; Recruiting
Jochen M Schmitt, MD MPH, Phone: 00493514582421, Email: jochen.schmitt@uniklinikum-dresden.de
Jochen M Schmitt, MD MPH, Principal Investigator
Marlene Lochno, Sub-Investigator
Knut Schäkel, PD, MD, Sub-Investigator
University Hospital Kiel, Kiel 24105, Germany; Recruiting
Regina Fölster-Holst, PD, MD, Phone: 0049 431 5971512
Regina Fölster-Holst, PD, MD, Principal Investigator
Shirin Filsoof, Sub-Investigator
Konstanze Müller-Wening, Sub-Investigator
Dpt. of Dermatology, Medical Faculty Eppendorf, Hamburg 20246, Germany; Recruiting
Matthias Augustin, Prof., MD
Matthias Augustin, Prof., MD, Principal Investigator
Nadine Franzke, Sub-Investigator
Dpt. of Dermatology, University Hospital Münster, Münster 48149, Germany; Recruiting
Thomas Luger, Prof., MD
Thomas Luger, Prof., MD, Principal Investigator
Mareike Eickelmann, Sub-Investigator
Sarah Schulz, Sub-Investigator
Funda Schürmeyer-Horst, MD, Sub-Investigator
Additional Information
Starting date: March 2007
Ending date: May 2009
Last updated: July 7, 2008
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