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

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT00148746

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Atopic Dermatitis	Drug: Pimecrolimus Drug: Tacrolimus Drug: Prednisolone Drug: Ciclosporin A Drug: Dermatop	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Mar 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts 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