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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Kristian Reich, MD, Reich, Kristian, M.D.
ClinicalTrials.gov Identifier:
NCT01587755
First received: April 25, 2012
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Psoriasis
Other: TTOP
Other: non-TTOP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel

Resource links provided by NLM:


Further study details as provided by Reich, Kristian, M.D.:

Primary Outcome Measures:
  • Physician Global Assessment (PGA) [ Time Frame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1956
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Topical Treatment Optimizing Program
Optimized care
Other: TTOP
Patient is taken care of in an intensified, optimised manner
non-Topical Treatment Optimizing Program
Standard care
Other: non-TTOP
Standard medical care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587755

  Show 94 Study Locations
Sponsors and Collaborators
Kristian Reich, MD
LEO Pharma
Investigators
Principal Investigator: Kristian Reich, MD Prof.
  More Information

No publications provided

Responsible Party: Kristian Reich, MD, Reich, Kristian, M.D.
ClinicalTrials.gov Identifier: NCT01587755     History of Changes
Other Study ID Numbers: 055-006
Study First Received: April 25, 2012
Last Updated: April 10, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014