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

Primary Purpose

Moderate to Severe Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pimecrolimus
Tacrolimus
Prednisolone
Ciclosporin A
Dermatop
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Atopic Dermatitis focused on measuring atopic dermatitis, atopy

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Dermatology, TU Dresden

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
June 8, 2010
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00148746
Brief Title
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
Official Title
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Atopic Dermatitis
Keywords
atopic dermatitis, atopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Type
Drug
Intervention Name(s)
Ciclosporin A
Intervention Type
Drug
Intervention Name(s)
Dermatop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen M Schmitt, MD, MPH
Organizational Affiliation
Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18703875
Citation
Schmitt J, Meurer M, Schwanebeck U, Grahlert X, Schakel K. Treatment following an evidence-based algorithm versus individualised symptom-oriented treatment for atopic eczema. A randomised controlled trial. Dermatology. 2008;217(4):299-308. doi: 10.1159/000151355. Epub 2008 Aug 15.
Results Reference
derived

Learn more about this trial

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

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