Psoriasis VulgarisPSOREALNCT02935582
PSOREAL - Managing PSOriasis in the REAL World
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 3 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Enstilar® aerosol foam and Other topical
- How many people
- 1,214 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participation in the active treatment phase of a clinical trial
- Previous enrollment in the study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Layton Medical Centre
Blackpool, Lancashire, FY3 7EN
About this study
Official title: 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).
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Enstilar® aerosol foam, Other topical
- Keywords
- Topical, Real-world, Local standard of care, Non-interventional, Calcipotriol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enstilar® aerosol foamDrug
Also called calcipotriol/betamethasone dipropionate aerosol foam
Treatment according to local labelling
Other topicalDrug
Also called Standard topical therapy
Treatment according to local practise
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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® Receives: Drug: Other topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaGA
Patient reported Global Assessment
Measured: 4 weeks
Itch
Itch dimension of Psoriasis Symptom Inventory (PSI) questionnaire
Measured: 1 week
Switch
Time to switch of topical treatment strategy
Measured: 1 year
Flare-up
Time to first flare-up after initial treatment completion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kreesten M Madsen, MD, PhD, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935582
- Sponsor's protocol ID
- NIS-ENSTILAR-1285
- Acronym
- PSOREAL
- Status last verified
- Jun 2021
- First submitted
- 14 Oct 2016
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Prospective, Observational Study of the Journey of Patients With Plaque Psoriasis Prescribed Calcipotriol/Betamethasone Aerosol Foam or Other Topical Therapy
- ClinicalTrials.gov ID
- NCT02935582
- Acronym / sponsor ID
- PSOREAL / NIS-ENSTILAR-1285
- Conditions
- Psoriasis Vulgaris
- Keywords
- Topical, Real-world, Local standard of care, Non-interventional, Calcipotriol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enstilar® | – | Drug: Enstilar® aerosol foamPatients 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 | – | Drug: Other topicalPatients for whom a new treatment strategy has been decided which involves start of topical treatment not including Enstilar® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in the active treatment phase of a clinical trial
- Previous enrollment in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enstilar® aerosol foamAlso: calcipotriol/betamethasone dipropionate aerosol foamTreatment according to local labelling | Drug | Enstilar® |
| Other topicalAlso: Standard topical therapyTreatment according to local practise | Drug | Other topical |
Primary outcome
PaGA
Time frame: 4 weeks
Patient reported Global Assessment
Itch
Time frame: 1 week
Itch dimension of Psoriasis Symptom Inventory (PSI) questionnaire
Switch
Time frame: 1 year
Time to switch of topical treatment strategy
Flare-up
Time frame: 1 year
Time to first flare-up after initial treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kreesten M Madsen, MD, PhD study director
LEO Pharma
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaGA (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.