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PSOREAL - Managing PSOriasis in the REAL World

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02935582
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 LEO Pharma
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kreesten M Madsen, MD, PhD
Principal Investigator Affiliation LEO Pharma
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Canada, Sweden, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris
Additional Details

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.

Arms & Interventions

Arms

: 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

: Other topical

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

Interventions

Drug: - Enstilar® aerosol foam

Treatment according to local labelling

Drug: - Other topical

Treatment according to local practise

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

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

Status

Recruiting

Address

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7

Site Contact

Chih-Ho Hong, MD

ogvdk@leo-pharma.com

+45 31471491

Stockholm, Sweden

Status

Completed

Address

Psoriasis association in Stockholm region

Stockholm, , 118 56

Layton Medical Centre, Blackpool, Lancashire, United Kingdom

Status

Active, not recruiting

Address

Layton Medical Centre

Blackpool, Lancashire, FY3 7EN

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