PSOREAL - Managing PSOriasis in the REAL World

Psoriasis Vulgaris Clinical Trial

— PSOREAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935582
• Other study ID #: NIS-ENSTILAR-1285
• Status: Completed
• Start date: January 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Enstilar® aerosol foam
Treatment according to local labelling
• Other topical
Treatment according to local practise

Locations

Country	Name	City	State
Canada	Dr. Chih-Ho Hong Medical Inc.	Surrey	British Columbia
Sweden	Psoriasis association in Stockholm region	Stockholm
United Kingdom	Layton Medical Centre	Blackpool	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  Sweden,  United Kingdom, 

Outcome

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