PSOREAL - Managing PSOriasis in the REAL World

NCT02935582 | Completed

• 1 other identifier: NIS-ENSTILAR-1285
• Study Type: observational
• Target: 1,214
• Locations: 3 countries
• Sites: 3

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).

Conditions

Psoriasis Vulgaris

Keywords

Topical; Real-world; Local standard of care; Non-interventional; Calcipotriol

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Other topical

Patients for whom a new treatment strategy has been decided which involves start of topical treatment not including Enstilar®

Drug: Other topical

Interventions

Enstilar® aerosol foam DRUG

Treatment according to local labelling

Also known as: calcipotriol/betamethasone dipropionate aerosol foam

Enstilar®

Other topical DRUG

Treatment according to local practise

Also known as: Standard topical therapy

Other topical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult age
• Psoriasis vulgaris
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (3)

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Psoriasis association in Stockholm region

Stockholm, 118 56, Sweden

Location

Layton Medical Centre

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

MeSH Terms

Interventions

calcipotriene

Study Officials

• Kreesten M Madsen, MD, PhD

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 17, 2016
• Study Start: January 1, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); SE (1); GB (1)