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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00148746
First received: September 6, 2005
Last updated: June 8, 2010
Last verified: June 2010
  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:


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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Dermatology, TU Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
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 Technische Universität Dresden:
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
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014