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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148746

Enrollment

Unknown

Registered

2005-09-08

Start date

2004-05-31

Completion date

2008-03-31

Last updated

2010-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Atopic Dermatitis

Keywords

atopic dermatitis, atopy

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.

Interventions

DRUGPimecrolimus

DRUGTacrolimus

DRUGPrednisolone

DRUGCiclosporin A

DRUGDermatop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026