NCT00148746CompletedNot Applicable
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- 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
- •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
Investigators
Study Sites (2)
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