Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Moderate to Severe Atopic Dermatitis
Intervention: Pimecrolimus (Drug); Tacrolimus (Drug); Prednisolone (Drug); Ciclosporin A (Drug); Dermatop (Drug)
Sponsored by: Dresden University of Technology
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
Official title: Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum age: 2 Years.
Maximum age: N/A.
- Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic
criteria by Raika and Hanifin
- 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
Locations and Contacts
Department of Dermatology, TU Dresden, Dresden 01307, Germany
Last updated: June 12, 2007