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Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test

This study has been completed.
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00236171
First received: October 4, 2005
Last updated: June 7, 2010
Last verified: June 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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
Study Completion Date: June 2010
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
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

No publications provided

Responsible Party: Gottfried Wozel, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00236171     History of Changes
Other Study ID Numbers: ETAPSO
Study First Received: October 4, 2005
Last Updated: June 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
topical therapy
Psoriasis Plaque Test

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methylprednisolone aceponate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013