Back to resultsEvaluation of Topical Antipsoriatics in the Psoriasis Plaque Test
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Protopic, Advantan
Blood and Urine Test
coherence tomography
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring topical therapy, Psoriasis Plaque Test
Eligibility 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
Sites / Locations
- Technische Universität Dresden
Outcomes
Primary Outcome Measures
sum score of psoriasis plaque tests on day 11
Secondary Outcome Measures
20-MHz-ultrasound and OCT on day 11
Full Information
NCT ID
NCT00236171
First Posted
October 4, 2005
Last Updated
June 7, 2010
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00236171
Brief Title
Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test
Official Title
Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
topical therapy, Psoriasis Plaque Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Protopic, Advantan
Intervention Type
Procedure
Intervention Name(s)
Blood and Urine Test
Intervention Type
Procedure
Intervention Name(s)
coherence tomography
Primary Outcome Measure Information:
Title
sum score of psoriasis plaque tests on day 11
Secondary Outcome Measure Information:
Title
20-MHz-ultrasound and OCT on day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gottfried Wozel, Professor
Organizational Affiliation
Technische Universität Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universität Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
0351
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test
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