PSOREAL; Protocol Code Number NIS-ENSTILAR-1285

• Research type

  Research Study

• Full title

  One-year prospective, observational study of the journey of patients with plaque psoriasis prescribed calcipotriol/betamethasone aerosol foam or other topical therapy

• IRAS ID

  211434

• Contact name

  Paul Hargreaves

• Contact email

  PYHDK@leo-pharma.com

• Sponsor organisation

  LEO Pharma A/S

• Clinicaltrials.gov Identifier

  Not yet assigned, ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/14/2016; NIS-ENSTILAR-1285

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Summary of Research
  This study aims to map the interaction of unselected adult psoriasis vulgaris patients with Healthcare Professionals for a year, and document how these patients interact with their psoriasis, as they perceive and report it directly into the study database. It will describe the current treatment patterns and the treatment outcomes of these treatments and the newly introduced calcipotriol/betamethasone dipropionate foam fixed combination for the topical treatment of psoriasis in the real life setting.
  Through the collection of data from patients the study aspires to identify treatment strategies leading to improved long-term management of this chronic skin condition.
  Current clinical psoriasis guidelines review short-term treatment options based on the level of supporting evidence, but fall short in actually guiding the physicians on how to best help patients manage their disease in the chronic course of psoriasis vulgaris.
  Eligibility criteria includes:
  • Adult age with psoriasis vulgaris, plaques on the body of at least mild severity at time of inclusion; Decision to prescribe a topical psoriasis treatment for body use where the prescription is NOT a routine renewal of the prescription of an ongoing therapy; Signed and dated informed consent; Willingness and ability to enter personal disease and treatment information onto a secure webpage
  The sites participating will be both primary and secondary care across the UK and Ireland. All patients will be observed for up to 1 year or until withdrawal of consent to collect additional data.
  Investigators enter data at baseline and at any patient contact throughout the duration of the study, with a medical chart review of data completeness and Case Report Form sign-off at one year. Patients enter data on their electronic device at baseline and at times of treatment changes and other key events (e.g. HCP contacts, resuming daily treatment and one year after enrolment).

  Summary of Results
  Summary details will be uploaded onto the EU PAS register - Link below
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUYajZYRp-2BKKehJCCXWGb3ds4FZ-2FkQXu4n9g-2BT-2FBACtkkpnxyT2Wi8B5iL1OTVfHVg-3D-3D-pBf_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLy8mwatM-2FMu-2BqkNyDD1m68gVDq5KlTi7k6a1nSmmwjYUVLU90BWjb5xKH0zaXxAVgchMpn0xlHDm8FHSzHv9y5JAuAbqesinX6UcFy1w6-2FfHMvqmwrPZbBjfkdpKEKPozcOqd3Bz82rPty7bw3doFOtmiOfJZdJl8F7alv2CRNhg-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C4a38d5da643e4234709f08d9ebecd19d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637800224624833816%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=wBhfAeLWtzOoSzdKIofykOAZw01fvfgkI473UiNhNlI%3D&reserved=0

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  16/NE/0403

• Date of REC Opinion

  5 Dec 2016

• REC opinion

  Favourable Opinion