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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148746
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : June 9, 2010
Information provided by:
Technische Universität Dresden

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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Atopic Dermatitis Drug: Pimecrolimus Drug: Tacrolimus Drug: Prednisolone Drug: Ciclosporin A Drug: Dermatop Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
Study Start Date : May 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148746

Department of Dermatology, TU Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Study Director: Jochen M Schmitt, MD, MPH Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00148746     History of Changes
Other Study ID Numbers: DERMA_AD_001
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by Technische Universität Dresden:
atopic dermatitis, atopy

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal