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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00236171
Other study ID # ETAPSO
Secondary ID
Status Completed
Phase N/A
First received October 4, 2005
Last updated June 7, 2010
Start date September 2004
Est. completion date June 2010

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 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


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


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 2010
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Protopic, Advantan

Procedure:
Blood and Urine Test

coherence tomography


Locations

Country Name City State
Germany Technische Universität Dresden Dresden Sachsen

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary sum score of psoriasis plaque tests on day 11
Secondary 20-MHz-ultrasound and OCT on day 11
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