Psoriasis Topical Treatment Optimising Programme (PSO-TOP; v1.0)

• Research type

  Research Study

• Full title

  Optimising outpatient care in mild to moderate psoriasis by a newly developed ‘Topical Treatment Optimising Programme’ - an international study using Daivobet®/Dovobet® Gel (‘PSO-TOP’)

• IRAS ID

  89423

• Contact name

  Richard Warren

• Sponsor organisation

  c/o SCIderm GmbH

• Eudract number

  2011-001697-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Psoriasis is a common, disabling, chronically-relapsing inflammatory disorder of the skin in which adherence to treatment is often poor. For patients on long-term therapy due to a chronic condition, adherence to therapy is essential for achieving optimal outcomes. In order to investigate poor treatment adherence in psoriasis, this study aims to assess the value of a Topical Treatment Optimising Programme (TTOP) in the topical treatment of insufficiently treated mild to moderate psoriasis after 8 weeks or 64 weeks of treatment with Dovobet© Gel (standard treatment). Dovobet© Gel will be used once daily for the first 8 weeks and then on an "as needed" basis thereafter. The TTOP has been developed in accordance with relevant Patient Boards and Expert Advisory Boards. The study will involve two arms (TTOP - intervention arm) and non-TTOP (comparator arm). Patients will be randomised to standardised topical psoriasis treatment (Dovobet© Gel) either with or without a TTOP to ensure that the enrolment to each study arm is unbiased. Patients will attend the clinic every 8 weeks up to the final visit at week 64.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  11/YH/0451

• Date of REC Opinion

  14 Feb 2012

• REC opinion

  Further Information Favourable Opinion