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

This study has been completed.
LEO Pharma
Information provided by (Responsible Party):
Kristian Reich, MD, Reich, Kristian, M.D. Identifier:
First received: April 25, 2012
Last updated: March 6, 2015
Last verified: March 2015
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
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 ]
    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.

Enrollment: 1852
Study Start Date: March 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01587755

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