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

Information source: Technische Universitšt Dresden
ClinicalTrials.gov processed this data on August 23, 2015
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)

Phase: N/A

Status: Completed

Sponsored by: Technische Universitšt 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

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.

Clinical Details

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

Eligibility

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

Locations and Contacts

Department of Dermatology, TU Dresden, Dresden 01307, Germany
Additional Information

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

Page last updated: August 23, 2015

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