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

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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
Study Completion Date:	January 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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

Locations

Austria
University Hospital of Dermatology and Venerology Graz
Graz, Austria, 8036
Germany
Dept. of Dermatology, Medical Faculty, TU Dresden
Dresden, Germany, 01307
Dpt. of Dermatology, Medical Faculty Eppendorf
Hamburg, Germany, 20246
University Hospital Kiel
Kiel, Germany, 24105
Dpt. of Dermatology, University Hospital Münster
Münster, Germany, 48149

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 by Dresden University of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schmitt J, Schäkel K, Fölster-Holst R, Bauer A, Oertel R, Augustin M, Aberer W, Luger T, Meurer M. Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial. Br J Dermatol. 2010 Mar;162(3):661-8. Epub 2009 Oct 26.

Responsible Party:	Jochen Schmitt, MD, MPH, Technical University Dresden
ClinicalTrials.gov Identifier:	NCT00445081 History of Changes
Other Study ID Numbers:	TUD_PROVE_001, EudraCT-Nr:2006-003667-31
Study First Received:	March 7, 2007
Last Updated:	October 28, 2010
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:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on February 12, 2012