Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJune 9, 2010
June 1, 2010
2.3 years
September 6, 2005
June 8, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic criteria by Raika and Hanifin
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, TU Dresden
Dresden, 01307, Germany
Related Publications (1)
Schmitt J, Meurer M, Schwanebeck U, Grahlert X, Schakel K. Treatment following an evidence-based algorithm versus individualised symptom-oriented treatment for atopic eczema. A randomised controlled trial. Dermatology. 2008;217(4):299-308. doi: 10.1159/000151355. Epub 2008 Aug 15.
PMID: 18703875DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jochen M Schmitt, MD, MPH
Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
May 1, 2004
Primary Completion
September 1, 2006
Study Completion
March 1, 2008
Last Updated
June 9, 2010
Record last verified: 2010-06