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

Moderate to Severe Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148746
• Other study ID #: DERMA_AD_001
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: June 8, 2010
• Start date: May 2004
• Est. completion date: March 2008

Study information

• Verified date: June 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate to Severe Atopic Dermatitis

Intervention

Drug:
• Pimecrolimus

• Tacrolimus

• Prednisolone

• Ciclosporin A

• Dermatop

Locations

Country	Name	City	State
Germany	Department of Dermatology, TU Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany,