drugset / Trial / NCT00148746

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

NCT00148746 ↗

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2004-05
Primary completion
2006-09
Completion
2008-03

Outcome

Missed primary endpoint

paper No statistically significant differences in clinical or subjective response were observed between groups. PMID 18703875 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide — —
Subject Pimecrolimus Small molecule — —
Subject Prednicarbate Small molecule — —
Subject Prednisolone Other / unclassified — —
Subject Tacrolimus Small molecule — —

Indications