Prednisolone vs. Ciclosporine in Severe Atopic Eczema - Full Text View

Prednisolone vs. Ciclosporine in Severe Atopic Eczema (PROVE)

This study is currently recruiting participants.

Verified by Dresden University of Technology, July 2008

First Received: March 7, 2007 Last Updated: July 7, 2008 History of Changes

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00445081

Purpose

To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Prednisolone Drug: Ciclosporine A	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Resource links provided by NLM:

MedlinePlus related topics: Eczema

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

stable remission in both treatment groups

Secondary Outcome 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

Estimated Enrollment:	66
Study Start Date:	March 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Prednisolone
2: Active Comparator	Drug: Ciclosporine A

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445081

Contacts

Contact: Jochen M Schmitt, MD, MPH	0049 351 458 ext 2421	Jochen.Schmitt@uniklinikum-dresden.de
Contact: Michael Meurer, Prof., MD	0049 351 458 ext 2497

Locations

Austria
University Hospital of Dermatology and Venerology Graz	Recruiting
Graz, Austria, 8036
Contact: Werner Aberer, Prof., MD
Principal Investigator: Werner Aberer, Prof., MD
Sub-Investigator: Christian Schuster, MD
Germany
Dept. of Dermatology, Medical Faculty, TU Dresden	Recruiting
Dresden, Germany, 01307
Contact: Jochen M Schmitt, MD MPH 00493514582421 jochen.schmitt@uniklinikum-dresden.de
Principal Investigator: Jochen M Schmitt, MD MPH
Sub-Investigator: Marlene Lochno
Sub-Investigator: Knut Schäkel, PD, MD
University Hospital Kiel	Recruiting
Kiel, Germany, 24105
Contact: Regina Fölster-Holst, PD, MD 0049 431 5971512
Principal Investigator: Regina Fölster-Holst, PD, MD
Sub-Investigator: Shirin Filsoof
Sub-Investigator: Konstanze Müller-Wening
Dpt. of Dermatology, Medical Faculty Eppendorf	Recruiting
Hamburg, Germany, 20246
Contact: Matthias Augustin, Prof., MD
Principal Investigator: Matthias Augustin, Prof., MD
Sub-Investigator: Nadine Franzke
Dpt. of Dermatology, University Hospital Münster	Recruiting
Münster, Germany, 48149
Contact: Thomas Luger, Prof., MD
Principal Investigator: Thomas Luger, Prof., MD
Sub-Investigator: Mareike Eickelmann
Sub-Investigator: Sarah Schulz
Sub-Investigator: Funda Schürmeyer-Horst, MD

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Jochen M Schmitt, MD MPH

Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden

More Information

No publications provided

Responsible Party:	Technical University Dresden ( Jochen Schmitt, MD, MPH )
Study ID Numbers:	TUD_PROVE_001, EudraCT-Nr:2006-003667-31
Study First Received:	March 7, 2007
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00445081 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

atopic dermatitis
prednisolone
ciclosporine
SCORAD

DLQI
QALY
WLQ

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Hormones
Hypersensitivity
Therapeutic Uses
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Methylprednisolone Hemisuccinate
Immune System Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Protective Agents
Glucocorticoids
Pharmacologic Actions
Genetic Diseases, Inborn
Autonomic Agents
Prednisolone
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009