Prednisolone vs. Ciclosporine in Severe Atopic Eczema - Tabular View

Tracking Information

First Received Date ^ICMJE

March 7, 2007

Last Updated Date

July 7, 2008

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

stable remission in both treatment groups

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00445081 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

response rate in both treatment groups
relaps 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

Descriptive Information

Brief Title ^ICMJE

Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Official Title ^ICMJE

Prednisolone vs. Ciclosporine in Severe Atopic Eczema

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: Prednisolone
Drug: Ciclosporine A

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT ID ^ICMJE

NCT00445081

Responsible Party

Jochen Schmitt, MD, MPH, Technical University Dresden

Study ID Numbers ^ICMJE

TUD_PROVE_001, EudraCT-Nr:2006-003667-31

Study Sponsor ^ICMJE

Dresden University of Technology

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jochen M Schmitt, MD MPH

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

Information Provided By

Dresden University of Technology

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP