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OpenTrials
Completed

NCT Number: NCT02935582

PSOREAL - Managing PSOriasis in the REAL World

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Chih-Ho Hong Medical Inc., Surrey, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enstilar® aerosol foam

Drug

Treatment according to local labelling

Other names: calcipotriol/betamethasone dipropionate aerosol foam

Other topical

Drug

Treatment according to local practise

Other names: Standard topical therapy

Primary outcomes

  1. PaGA

    Time frame: 4 weeks

    Patient reported Global Assessment

  2. Itch

    Time frame: 1 week

    Itch dimension of Psoriasis Symptom Inventory (PSI) questionnaire

  3. Switch

    Time frame: 1 year

    Time to switch of topical treatment strategy

  4. Flare-up

    Time frame: 1 year

    Time to first flare-up after initial treatment completion

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

One-year Prospective, Observational Study of the Journey of Patients With Plaque Psoriasis Prescribed Calcipotriol/Betamethasone Aerosol Foam or Other Topical Therapy

Acronym: PSOREAL

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2016
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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