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

This study has been completed.
Information provided by:
Technische Universität Dresden Identifier:
First received: September 6, 2005
Last updated: June 8, 2010
Last verified: June 2010

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:

Further study details as provided by Technische Universität Dresden:

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

No publications provided 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 Technische Universität Dresden:
atopic dermatitis, atopy

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 08, 2016