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PSOREAL - Managing PSOriasis in the REAL World (PSOREAL)

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ClinicalTrials.gov Identifier: NCT02935582
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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).

Condition or disease Intervention/treatment
Psoriasis Vulgaris 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
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : January 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: 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 Name: Standard topical therapy




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935582


Contacts
Contact: Lise S Skov-Ettrup, PhD +45 31471491 ogvdk@leo-pharma.com
Contact: Benjamin August, PhD +45 31252382 etbdk@leo-pharma.com

Locations
Sweden
Psoriasis association in Stockholm region Recruiting
Stockholm, Sweden, 118 56
Contact: Birgitta W Claréus, MD    +46(0)70 747 37 59    birgitta.clareus@ptj.se   
United Kingdom
Layton Medical Centre Recruiting
Blackpool, Lancashire, United Kingdom, FY3 7EN
Contact: Rebecca Dr Clark, MBChB MRCGP DFSRH    +44 1253 951943    Rebecca.clark@gp-p81066.nhs.uk   
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Kreesten M Madsen, MD, PhD LEO Pharma

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02935582     History of Changes
Other Study ID Numbers: NIS-ENSTILAR-1285
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by LEO Pharma:
Topical
Real-world
Local standard of care
Non-interventional
Calcipotriol

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents