Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

February 9, 2012 updated by: LEO Pharma
The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

588

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • University Clinic of Erlangen Nuernberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients visiting their attending dermatologist in the primary care clinic

Description

Inclusion Criteria:

  • Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway

Exclusion Criteria:

  • Previous therapy with Daivobet® Gel
  • Systemic therapy of psoriasis vulgaris
  • Contraindications of Daivobet® Gel in the German package insert

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handling of Daivobet® Gel
Time Frame: After appr 4 weeks
Compared to previous topical treatment: Time required for application (previous treatment versus present treatment), time required until dressing is possible (previous treatment versus present treatment)
After appr 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 4 weeks
Dermatology Life Quality Index (DLQI)
4 weeks
Physician's global Assessment of psoriasis vulgaris
Time Frame: 4 weeks
6-step scale from "no visible disease (O)" to "very severe disease (5)
4 weeks
Side effects
Time Frame: 4 weeks
number of participants with serious and non-serious adverse drug reactions, according to organ classes
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

LEO Pharma GmbH, Neu-Isenburg, Germany

Investigators

  • Principal Investigator: Michael Sticherling, Prof dr med, University clinic Erlangen-Nuernberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment with Daivobet® Gel

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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