NCT00236171

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

1.6 years

First QC Date

October 4, 2005

Last Update Submit

June 7, 2010

Conditions

Psoriasis Vulgaris

Keywords

topical therapyPsoriasis Plaque Test

Outcome Measures

Primary Outcomes (1)

  • sum score of psoriasis plaque tests on day 11

Secondary Outcomes (1)

  • 20-MHz-ultrasound and OCT on day 11

Interventions

Protopic, AdvantanDRUG
Blood and Urine TestPROCEDURE
coherence tomographyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 Years
  • Negative urine pregnancy test
  • Written informed consent
  • Good compliance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden

Dresden, Saxony, 0351, Germany

Location

MeSH Terms

Interventions

Tacrolimusmethylprednisolone aceponateBlood Specimen CollectionUrinalysisTomography, Optical Coherence

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesClinical Chemistry TestsDiagnostic Techniques, UrologicalTomography, OpticalOptical ImagingDiagnostic ImagingTomography

Study Officials

  • Gottfried Wozel, Professor

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 12, 2005

Study Start

September 1, 2004

Primary Completion

April 1, 2006

Study Completion

June 1, 2010

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations

DE(1)