Clinical trial NCT02935582: PSOREAL - Managing PSOriasis in the REAL World
Official title: One-year Prospective, Observational Study of the Journey of Patients With Plaque Psoriasis Prescribed Calcipotriol/Betamethasone Aerosol Foam or Other Topical Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Keywords: Topical
Real-world
Local standard of care
Non-interventional
Calcipotriol
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients starting treatment with Enstilar® or other topical treatment of body and/or extremities in one of the countries participating in the study. Patients receiving a prescription renewal for an ongoing topical treatment are not eligible. Patients undergoing systemic treatment can be included as well, provided they receive a prescription for concomitant use of topical treatment on body and/or extremities and this is not a prescription renewal. The minimum age may vary slightly, as in some countries adult age differ from 18 years of age.

Brief summary: Multinational real-life study of current psoriasis treatment strategies, topical treatment patterns and treatment outcomes of these treatments, including the newly introduced calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar® (calcipotriol/betamethasone dipropionate).

Detailed description: This multinational study aims to describe current treatment patterns and outcomes in the diversity of the real life setting: local differences in access to drugs and current treatment practices, and regional cultural differences, covering adult patients of all backgrounds, sex, socio-economic standing, health background, comorbidity and co-medication. A total of around 400 real-life prescribers in 3-8 countries are expected to participate over the years, with each country contributing data to the study for around 2 years, starting data collection within the first year after local market introduction of Enstilar®.

The real-life prescribing and utilization patterns of topical prescription products approved for treatment of psoriasis vulgaris in the individual participating countries will be mapped and performance of the products in real life will be investigated based primarily on baseline data from investigators and patient reported data contributed by the individual patient for 1 year. Patients are expected to enter data on their electronic device at baseline and at times of treatment changes and other key events, and investigators are expected to contribute data after each contact with the patient.

Patients will be approached for informed consent to participate in the study after their individual treatment plan has been decided. The study aims to include two patients on other topical treatment for every patient planned to receive Enstilar® in order to ensure a sufficient sample of Enstilar® treated patients to capture the diversity of real-life prescription patterns in patients not on Enstilar®, and to allow for sufficiently powered comparisons between Enstilar® and other real-world treatment strategies. A systematic approach will be used to select eligible patients to be approached for study participation in order to minimize selection bias and control seasonal variations.

Eligibility criteria: Inclusion Criteria:

* Adult age
* Psoriasis vulgaris
* Plaques on the body (trunk and/or extremities) 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 during the one year individual study period, using their existing access to a PC or electronic device and a personal access code.

Exclusion Criteria:

* Participation in the active treatment phase of a clinical trial
* Previous enrollment in the study

Primary outcomes:
measure: PaGA
timeFrame: 4 weeks
measure: Itch
timeFrame: 1 week
measure: Switch
timeFrame: 1 year
measure: Flare-up
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Dr. Chih-Ho Hong Medical Inc.
state: British Columbia
city: Stockholm
country: Sweden
facility: Psoriasis association in Stockholm region
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
state: Lancashire
Study officials:
affiliation: LEO Pharma
name: Kreesten M Madsen, MD, PhD
role: STUDY_DIRECTOR
References: