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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Cyclosporine; Cyclosporins; Pimecrolimus; Prednicarbate; Prednisolone; Tacrolimus

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