Evaluation of Topical Antipsoriatics in the Psoriasis Pla... | NCT00236171

Studies
Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test

NCT00236171

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jun 8, 2010Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Psoriasis Vulgaris

Interventions

Protopic, Advantan
Blood and Urine Test
coherence tomography

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Jun 2010Actual

First Submitted Date

Oct 4, 2005

First Submission Date that Met QC Criteria

Oct 10, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2010

Last Update Posted Date

Jun 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Measure	Description	Time Frame
sum score of psoriasis plaque tests on day 11

Measure	Description	Time Frame
20-MHz-ultrasound and OCT on day 11

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gottfried Wozel, Professor	Technische Universität Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Technische Universität Dresden		Dresden	Saxony	0351	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus
C078007	methylprednisolone aceponate
D001800	Blood Specimen Collection
D016482	Urinalysis
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D013048	Specimen Handling

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Protopic, Advantan	Drug
Blood and Urine Test	Procedure
coherence tomography	Procedure