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

Sponsored by:	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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis

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

Study ID Numbers:	DERMA_AD_001
Study First Received:	September 6, 2005
Last Updated:	June 12, 2007
ClinicalTrials.gov Identifier:	NCT00148746
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

atopic dermatitis, atopy

Study placed in the following topic categories:

Dermatitis, Atopic
Cyclosporine
Skin Diseases
Clotrimazole
Methylprednisolone
Miconazole
Tioconazole
Methylprednisolone acetate
Pimecrolimus
Prednisolone acetate

Tacrolimus
Cyclosporins
Hypersensitivity
Genetic Diseases, Inborn
Prednisolone
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Methylprednisolone Hemisuccinate
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antineoplastic Agents, Hormonal
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Hormones
Glucocorticoids

Immunosuppressive Agents
Pharmacologic Actions
Sensory System Agents
Analgesics, Non-Narcotic
Antifungal Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009