PSOREAL - Managing PSOriasis in the REAL World (PSOREAL)

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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Enstilar® aerosol foam; Drug: Other topical

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.

• Study Type: Observational
• Enrollment (Actual): 1214

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc.
• Sweden
  • Stockholm, Sweden, 118 56
    • Psoriasis association in Stockholm region
• United Kingdom
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY3 7EN
      • Layton Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enstilar®; Patients for whom a new treatment strategy has been decided which involves start of topical treatment with Enstilar® according to the current local labelling	Drug: Enstilar® aerosol foam; Treatment according to local labelling; Other Names: calcipotriol/betamethasone dipropionate aerosol foam
Other topical; Patients for whom a new treatment strategy has been decided which involves start of topical treatment not including Enstilar®	Drug: Other topical; Treatment according to local practise; Other Names: Standard topical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaGA	Patient reported Global Assessment	4 weeks
Itch	Itch dimension of Psoriasis Symptom Inventory (PSI) questionnaire	1 week
Switch	Time to switch of topical treatment strategy	1 year
Flare-up	Time to first flare-up after initial treatment completion	1 year

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Kreesten M Madsen, MD, PhD, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Topical; Non-interventional; Calcipotriol; Real-world; Local standard of care
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: NIS-ENSTILAR-1285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No