Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test - Full Text View

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00236171

Purpose

The purpose of this study is to evaluate the efficacy of the topical therapies Protopic and Advantan as well as their combination against placebo in a Psoriasis Plaque Test

Condition	Intervention
Psoriasis Vulgaris	Drug: Protopic, Advantan Procedure: Blood and Urine Test Procedure: coherence tomography

MedlinePlus related topics: Psoriasis

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

sum score of psoriasis plaque tests on day 11

Secondary Outcome Measures:

20-MHz-ultrasound and OCT on day 11

Enrollment:	14
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2008
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Detailed Description:

daily psoriasis plaque tests for two weeks and optical coherence tomography (OCT) and 20-MHz-ultrasound on day 0 and day 11, 10 days post end of treatment and 20 days post end of treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients older than 18 Years
Negative urine pregnancy test
Written informed consent
Good compliance

Exclusion Criteria:

Patients less than 18 years
Pregnant patients
Patients with renal insufficiency, liver diseases
Patients who received systemic antipsoriatic treatment or UV treatment less than 4 weeks prior to study
Patients who used topical antipsoriatics within two weeks prior to study
Immunosuppressed Patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236171

Locations

Germany, Sachsen
Technische Universität Dresden
Dresden, Sachsen, Germany, 0351

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Gottfried Wozel, Professor

Technische Universität Dresden

More Information

Responsible Party:	Technical University Dresden ( Gottfried Wozel, MD )
Study ID Numbers:	ETAPSO
Study First Received:	October 4, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00236171
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

topical therapy
Psoriasis Plaque Test

Study placed in the following topic categories:

Methylprednisolone aceponate
Skin Diseases
Psoriasis
Tacrolimus
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009