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

Condition(s) targeted: Moderate to Severe Atopic Dermatitis

Intervention: Pimecrolimus (Drug); Tacrolimus (Drug); Prednisolone (Drug); Ciclosporin A (Drug); Dermatop (Drug)

Phase: N/A

Status: Completed

Sponsored by: Technische Universität Dresden

Official(s) and/or principal investigator(s):
Jochen M Schmitt, MD, MPH, Study Director, Affiliation: Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

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

Department of Dermatology, TU Dresden, Dresden 01307, Germany

Starting date: May 2004
Last updated: June 8, 2010