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

Phase 4

Completed

• Conditions: Mild to Moderate Psoriasis
• Interventions: Other: non-TTOP; Other: TTOP

• Registration Number: NCT01587755
• Lead Sponsor: Kristian Reich, MD

Brief Summary

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

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1852

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-Topical Treatment Optimizing Program	non-TTOP	Standard care
Topical Treatment Optimizing Program	TTOP	Optimized care

Primary Outcome Measures

Name	Time	Method
Physician Global Assessment (PGA)	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.