Prednisolone vs. Ciclosporine in Severe Atopic Eczema | NCT00445081

Studies
Prednisolone vs. Ciclosporine in Severe Atopic Eczema

NCT00445081

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Oct 29, 2010Estimated

Enrollment

66Estimated

Phase

Phase 4

Conditions

Atopic Dermatitis

Interventions

Prednisolone
Ciclosporine A

Countries

Austria
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT-Nr:2006-003667-31

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Mar 7, 2007

First Submission Date that Met QC Criteria

Mar 7, 2007

First Posted Date

Mar 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2010

Last Update Posted Date

Oct 29, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Prednisolone
2	Active Comparator		Drug: Ciclosporine A

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone	Drug		1
Ciclosporine A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stable remission in both treatment groups

Secondary Outcomes

Measure	Description	Time Frame
response rate in both treatment groups
relapse rate in both treatment groups
mean change in objective SCORAD in both treatment groups

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen M Schmitt, MD MPH	Dpt. of Dermatology, TU Dresden, Fetscherstr 74, D-01307 Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Dermatology and Venerology Graz		Graz		8036	Austria
Dept. of Dermatology, Medical Faculty, TU Dresden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19863501	Derived	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.

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids