Standardized Time- and Score-oriented Treatment of Modera... | NCT00148746

Studies
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis

NCT00148746

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jun 9, 2010Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Moderate to Severe Atopic Dermatitis

Interventions

Pimecrolimus
Tacrolimus
Prednisolone
Ciclosporin A
Dermatop

Countries

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

Status Module

Record Verification Date

Jun 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

May 2004

Primary Completion Date

Sep 2006Actual

Completion Date

Mar 2008Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 2005Estimated

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

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Description Module

Brief Summary

The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis.

Study Type: Mono-centre study, patients are blinded, physicians are randomized to either treat study- or controll group

Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study visits every 4 weeks.

Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.

Secundary endpoints are quality of life, safety and economic burden in both treatment groups.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic criteria by Raika and Hanifin

Exclusion Criteria:

Pregnancy
Nursing
Women in childbearing age without contraception
Drug - and or alcohol abuse
Gene defects that are associated with increased light sensibility, e.g. Xeroderma pigmentosum, Cockayne Syndrome, Bloom Syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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, Medical Faculty, Technical University Dresden, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, TU Dresden		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18703875	Derived	Schmitt J, Meurer M, Schwanebeck U, Grahlert X, Schakel K. Treatment following an evidence-based algorithm versus individualised symptom-oriented treatment for atopic eczema. A randomised controlled trial. Dermatology. 2008;217(4):299-308. doi: 10.1159/000151355. Epub 2008 Aug 15.

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

ID	Term
C117268	pimecrolimus
D016559	Tacrolimus
D011239	Prednisolone
D003524	Cyclosporins
C035287	prednicarbate

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D011246	Pregnadienetriols

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus	Drug
Tacrolimus	Drug
Prednisolone	Drug
Ciclosporin A	Drug
Dermatop	Drug