Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP) (PSO-TOP)

March 6, 2015 updated by: Kristian Reich, MD

Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel

A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board. This tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. The study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. The TTOP will be compared to standardised regular care (called 'non-TTOP'). It is intended to clinically show the importance of an optimised contact between the patient and health care professional.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1852

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

  • Denmark
      • Herning, Denmark
      • Hobro, Denmark
      • Roskilde, Denmark
      • Vejle, Denmark
  • France
      • Angers Cedex 9, France
      • Auxerre, France
      • Brest, France
      • Lille Cedex, France
      • Limeil Brevannes, France
      • Marseille Cedex 08, France
      • Martigues, France
      • Paris Cedex 10, France
      • Poitiers Cedex, France
      • Saint Mande, France
      • Saint Priest en Jarez, France
      • Saint-Germain en Laye, France
      • Tours Cedex 1, France
      • Vienne, France
  • Germany
      • Bad Bentheim, Germany
      • Berlin, Germany
      • Biberach, Germany
      • Blaubeuren, Germany
      • Bochum, Germany
      • Buchholz, Germany
      • Dessau, Germany
      • Frankfurt, Germany
      • Friedrichshafen, Germany
      • Gilching, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Kiel, Germany
      • Köln, Germany
      • Mahlow, Germany
      • Osnabrück, Germany
      • Pinneberg, Germany
      • Selters, Germany
      • Weißenfels, Germany
      • Wolfenbüttel, Germany
      • Wuppertal, Germany
  • Italy
      • Brescia, Italy
      • Catania, Italy
      • Genova, Italy
      • L'Aquila, Italy
      • Lucca, Italy
      • Messina, Italy
      • Padova, Italy
      • Palermo, Italy
      • Parma, Italy
      • Pavia, Italy
      • Perugia, Italy
      • Rome, Italy
      • Trapani, Italy
      • Verona, Italy
  • Netherlands
      • Amsterdam, Netherlands
      • Geldrop, Netherlands
      • Maastricht, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
  • Spain
      • Alicante, Spain
      • Barcelona, Spain
      • Barcelona,, Spain
      • Fuenlabrada (Madrid), Spain
      • Getafe (Madrid), Spain
      • Madrid, Spain
      • Palma de Mallorca, Spain
      • Tarragona, Spain
      • Valencia, Spain
      • Zaragoza, Spain
  • Sweden
      • Eskilstuna, Sweden
      • Göteborg, Sweden
      • Kristianstad, Sweden
      • Linköping, Sweden
      • Uppsala, Sweden
      • Örebrö, Sweden
  • United Kingdom
      • Bexhill, United Kingdom
      • Bradford, United Kingdom
      • Burbage, United Kingdom
      • Canterbury, United Kingdom
      • Cheshire, United Kingdom
      • Chesterfield, United Kingdom
      • Coventry, United Kingdom
      • Darwen, United Kingdom
      • East Sussex, United Kingdom
      • Leamington Spa, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Merseyside, United Kingdom
      • Middlesex, United Kingdom
      • Nantwich, United Kingdom
      • Nuneaton, United Kingdom
      • Oldham, United Kingdom
      • Tunbridge Wells, United Kingdom
      • Warwickshire, United Kingdom
      • West Sussex, United Kingdom

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients aged at least 18 years
  • Mild to moderate active plaque psoriasis with PGA ≥ 2 on the 7-point scale by Langley and Ellis and a Body Surface Area (BSA) of ≤ 10%
  • Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol/0.5mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
  • Written informed consent to participate in the study has been given prior to any study related procedures

Exclusion Criteria:

  • Severe renal insufficiency
  • Severe hepatic disorders
  • Known hyper calcaemia
  • Erythrodermic, exfoliative, pustular or guttate psoriasis
  • Facial or genital psoriasis
  • Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®/Dovobet® Gel
  • Pregnant and/or breast-feeding women
  • Hypersensitivity to the active substances or to any of the excipients
  • Suspected non-compliance with the clinical study procedures
  • Current participation in another clinical study

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0):

    • etanercept - within 4 weeks prior to Visit 1 (week 0)
    • adalimumab, alefacept, infliximab - within 2 months prior to Visit 1 (week 0)
    • ustekinumab - within 4 months prior to Visit 1 (week 0)
    • experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0)

  • Phototherapy within the following time periods prior to Visit 1 (week 0):

    • PUVA - within 4 weeks prior to Visit 1 (week 0)
    • UV-B - within 2 weeks prior to Visit 1 (week 0)

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Topical Treatment Optimizing Program
Optimized care
Other: TTOP
Patient is taken care of in an intensified, optimised manner
OTHER: non-Topical Treatment Optimizing Program
Standard care
Other: non-TTOP
Standard medical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physician Global Assessment (PGA)
Time Frame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start
PGA (Physician Global Assessment) will be assessed at all study visits. For week 8, the rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 will be calculated. This is the primary study parameter.
Up to 64 weeks; primary outcome assessed at week 8 after treatment start

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kristian Reich, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LEO Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristian Reich, MD Prof.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 055-006

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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