Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis - Full Text View

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00148746

Purpose

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.

Condition	Intervention
Moderate to Severe Atopic Dermatitis	Drug: Pimecrolimus Drug: Tacrolimus Drug: Prednisolone Drug: Ciclosporin A Drug: Dermatop

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis

Resource links provided by NLM:

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Cyclosporine Prednicarbate Medrol veriderm Cyclosporin Methylprednisolone Tacrolimus anhydrous Tacrolimus Pimecrolimus Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Study Start Date:	May 2004
Study Completion Date:	March 2008
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148746

Locations

Germany
Department of Dermatology, TU Dresden
Dresden, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators

Study Director:

Jochen M Schmitt, MD, MPH

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00148746 History of Changes
Other Study ID Numbers:	DERMA_AD_001
Study First Received:	September 6, 2005
Last Updated:	June 8, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

atopic dermatitis, atopy

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Tacrolimus
Pimecrolimus
Methylprednisolone acetate
Prednisolone acetate

Prednicarbate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012