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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Pimecrolimus

Intervention Type DRUG

Tacrolimus

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

Ciclosporin A

Intervention Type DRUG

Dermatop

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No