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Prednisolone vs. Ciclosporine in Severe Atopic Eczema

NCT ID: NCT00445081

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-01-31

Brief Summary

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

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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atopic dermatitis prednisolone ciclosporine SCORAD DLQI QALY WLQ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

Ciclosporine A

Intervention Type DRUG

Interventions

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Prednisolone

Intervention Type DRUG

Ciclosporine A

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Technical University Dresden

Principal Investigators

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Jochen M Schmitt, MD MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University Hospital of Dermatology and Venerology Graz

Graz, , Austria

Site Status

Dept. of Dermatology, Medical Faculty, TU Dresden

Dresden, , Germany

Site Status

Dpt. of Dermatology, Medical Faculty Eppendorf

Hamburg, , Germany

Site Status

University Hospital Kiel

Kiel, , Germany

Site Status

Dpt. of Dermatology, University Hospital Münster

Münster, , Germany

Site Status

Countries

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Austria Germany

References

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Schmitt J, Schakel K, Folster-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. doi: 10.1111/j.1365-2133.2009.09561.x. Epub 2009 Oct 26.

Reference Type DERIVED
PMID: 19863501 (View on PubMed)

Other Identifiers

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EudraCT-Nr:2006-003667-31

Identifier Type: -

Identifier Source: secondary_id

TUD_PROVE_001

Identifier Type: -

Identifier Source: org_study_id