Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

June 12, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00148746 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis

Official Title ^ICMJE

Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Moderate to Severe Atopic Dermatitis

Intervention ^ICMJE

Drug: Pimecrolimus
Drug: Tacrolimus
Drug: Prednisolone
Drug: Ciclosporin A
Drug: Dermatop

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

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00148746

Responsible Party

Study ID Numbers ^ICMJE

DERMA_AD_001

Study Sponsor ^ICMJE

Dresden University of Technology

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jochen M Schmitt, MD, MPH

Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany

Information Provided By

Dresden University of Technology

Verification Date

August 2005

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