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

Technische Universität Dresden

Status

Completed

Conditions

Moderate to Severe Atopic Dermatitis

Treatments

Drug: Dermatop

Drug: Tacrolimus

Drug: Ciclosporin A

Drug: Prednisolone

Drug: Pimecrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00148746

DERMA_AD_001

Details and patient eligibility

About

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.

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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