Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test

Psoriasis Vulgaris Clinical Trial

Official title:

Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236171
• Other study ID #: ETAPSO
• 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

• Psoriasis
• Psoriasis Vulgaris

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