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

NCT00148746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2010-06-09

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Atopic Dermatitis

Interventions

DRUG

Pimecrolimus

DRUG

Tacrolimus

DRUG

Prednisolone

DRUG

Ciclosporin A

DRUG

Dermatop

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Jochen M Schmitt, MD, MPH · Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-09-30
Completion
2008-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148746 on ClinicalTrials.gov