Psoriasis VulgarisPSO-CONTROLNCT03402828
Body PSOriasis: Long-term Relapse CONTROL
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 1 site in Russia.
Trial summary
This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. 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?
- Any topical drug treatment
- How many people
- 764 participants
- Where
- 1 siteRussia
- Study dates
- 11 Jun 2018to 15 May 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: Patients with psoriasis vulgaris attending one of the participating outpatient dermatology clinics entering a phase of prevention of relapse of psoriasis symptoms.
Who may be able to join
- Patients planned to receive topical treatment of any kind to prevent relapse of symptoms
- Written informed consent
Who cannot join
- Contraindications to selected treatment
- Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy
Trial locations and contacts
1 site in 1 country.
Russia1 site
The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan
Kazan', Tatarstan Republic, 420012
About this study
Official title: Body PSOriasis: Long-term Relapse Control in Patients With Psoriasis Vulgaris in Daily Clinical Practice of Russian Dermatologists.
This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Any topical drug treatment
- Keywords
- Topicals, Long-term
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any topical drug treatmentDrug
Also called Non-drug topicals
Any treatment strategy used to prevent relapse of psoriasis symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of relapse
Length of relapse free period after start of maintenance strategy
Measured: Up to 52 weeks
Secondary outcomes (3)
Dermatology Life Quality Index
Standard QoL measure within dermatology
Measured: Up to 52 weeks
PGA (physician's global assessment of symptoms)
5-point verbal rating scale
Measured: Up to 52 weeks
PsGA (patient's global assessment of symptoms)
5-point verbal rating scale
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start11 Jun 2018
- Primary completion15 May 2020
- Study completion15 May 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
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitry Petrunin, MD PhD, Study director, Leo Pharmaceutical Products LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402828
- Sponsor's protocol ID
- NIS-PSORIASIS-1379
- Acronym
- PSO-CONTROL
- Status last verified
- Dec 2019
- First submitted
- 11 Jan 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body PSOriasis: Long-term Relapse Control in Patients With Psoriasis Vulgaris in Daily Clinical Practice of Russian Dermatologists.
- ClinicalTrials.gov ID
- NCT03402828
- Acronym / sponsor ID
- PSO-CONTROL / NIS-PSORIASIS-1379
- Conditions
- Psoriasis Vulgaris
- Keywords
- Topicals, Long-term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 18 Jan 2018 (actual)
- 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.
This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriasis vulgaris attending one of the participating outpatient dermatology clinics entering a phase of prevention of relapse of psoriasis symptoms.
Key inclusion criteria (2 listed)
- Patients planned to receive topical treatment of any kind to prevent relapse of symptoms
- Written informed consent
Key exclusion criteria (2 listed)
- Contraindications to selected treatment
- Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy
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 |
|---|---|---|
| Any topical drug treatmentAlso: Non-drug topicalsAny treatment strategy used to prevent relapse of psoriasis symptoms | Drug | – |
Primary outcome
Time of relapse
Time frame: Up to 52 weeks
Length of relapse free period after start of maintenance strategy
3 secondary outcomes
Dermatology Life Quality Index
Time frame: Up to 52 weeks
PGA (physician's global assessment of symptoms)
Time frame: Up to 52 weeks
PsGA (patient's global assessment of symptoms)
Time frame: Up to 52 weeks
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 16 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Psoriasis Vulgaris
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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.
Dmitry Petrunin, MD PhD study director
Leo Pharmaceutical Products LLC
1 site in 1 country: 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 1 site in Russia.
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 2 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Time of relapse (time frame: Up to 52 weeks). 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 16 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.