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

Kristian Reich, MD

Status and phase

Completed

Phase 4

Conditions

Mild to Moderate Psoriasis

Treatments

Other: TTOP

Other: non-TTOP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01587755

055-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,852 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)