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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild to Moderate Psoriasis

Intervention / Treatment
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* Other: TTOP
* Other: non-TTOP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Topical Treatment Optimizing Program<br>Optimized care | Other: TTOP<br>* Patient is taken care of in an intensified, optimised manner<br>|
| Other: non-Topical Treatment Optimizing Program<br>Standard care | Other: non-TTOP<br>* Standard medical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment (PGA) | 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 |