PsoriasisPSODEEP1NCT05589298
The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis
An observational study of Psoriasis and Psoriasis; Arthritis (Etiology), run by Skane University Hospital at 1 site in Sweden.
Trial summary
PSODEEP 1 is a descriptive digital interview study where we intend to include at least 900 individuals. Individuals with known psoriasis or known psoriatic arthritis will access the digital interview via a QR code distributed via their rheumatology or dermatology department using their smartphones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriasis; Arthritis (Etiology), Koebner Phenomenon
- How many people
- 3,064 participants
- Where
- 1 siteSweden
- Study dates
- 19 Oct 2022to 14 Feb 2024
- 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 with psoriasis and/or psoriatic arthritis
Who may be able to join
- MD diagnosis of psoriasis and/or psoriasis arthritis
- Age over 18 years
- Ability to read and understand written questions
- Having/ability to use smartphone
- Given consent
Who cannot join
- Having participated previously
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Questionnaire on Self-reported Experience of Koebner and Deep-Koebner Phenomenon in Patients With Psoriasis and Psoriatic Arthritis.
PSODEEP 1 is a descriptive digital interview study where we intend to include at least 900 individuals. Individuals with known psoriasis or known psoriatic arthritis will access the digital interview via a QR code distributed via their rheumatology or dermatology department using their smartphones. Data on answers results are stored digitally and can be accessed parallel to recruitment. Questions focus on following fields (all self reported): background information (age/sex), disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.
Read the detailed description
PSODEEP1 is a descriptive digital interview study. Questions on self reported experience of following fields will be stated: background information, disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.
Questions will be distributed using REDCap (REsearch Electronic Data CAPture) platform provided by Lunds university, University of Santiago and Copenhagen University (www.project-redcap.org). Patients with known psoriasis or psoriatic arthritis will reach the questionnaire using a QR-code on patient's information sheet distributed in clinical settings. In Sweden, patients will be recruited at dermatology and rheumatology outpatient clinics in Malmö, Lund, Göteborg, Örebro, Stockholm (Skåne University Hospital, Karolinska Hospital, Sahlgrenska Hospital, Ryhov Hospital, Örebro, Hospital). In Chile patients will be recruited at Hospital Clínico Universidad de Chile and CIEC-PMR Centro Internacional de Estudios Clínicos - Probity Medical Research. In Denmark, patients will be recruited at Gentofte Hospital and through Leo foundation skin immunology research center (Copenhagen University) and the Parker Institute.
Study inclusion criteria: Physician diagnosed psoriasis, psoriatic arthritis or both. Age of 18 years or older. Ability to comprehend instructions and read the Swedish, Spanish or Danish language (according to country). Having a smartphone with which one can access the study questions using a QR code. Study exclusion criteria: Having participated in the study already. Not having a mobile telephone number (used to identify duplicate answers).
- Keywords
- Koebner, Deep-Koebner, Psoriasis, Arthritis
- Medical subject headings
- Psoriasis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSODEEP1 Sweden | Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Sweden. | |
| PSODEEP1 Denmark | Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Denmark. | |
| PSODEEP1 Chile | Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Chile. | |
| PSODEEP1 Netherlands | Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in the Netherlands. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Koebner
Occurence of Self-Reported Koebner phenomena. Self-reported in multiple choice questionnaire "Has your skin psoriasis ever developed at the site of a skin injury, such as a scrape or a burn?" YES/NO/DO NOT KNOW. Ordinal data.
Measured: Through study completion, estimated to 12 months.
Trauma induced Deep-Koebner
Occurence of Self-Reported trauma induced Deep-Koebner phenomena in patients with with psoriasis arthritis. Questionnaire, self-reported, multiple choice "Have you ever developed psoriatic arthritis in a joint after injury, e.g. after a fall or sprain? " YES/NO/DO NOT KNOW. Ordinal data.
Measured: Through study completion, estimated to 12 months.
Secondary outcomes (2)
Variation in Koebner
Variation of self-reported Koebner over time. In patients with self-reported Koebner a following multiple choice question will assess if Koebner is a constant phenomenon or whether it is associated with periods of high psoriasis disease activity. Multiple choice answers, self-reported, collected in questionnaire. Ordinal data.
Measured: Through study completion, estimated to 12 months.
Variation in Trauma induced Deep-Koebner
Variation of self-reported Trauma induced Deep-Koebner over time. In patients with self-reported trauma induced Deep-Koebner a following multiple choice question will assess if Deep-Koebner is a constant phenomenon or whether it is associated with periods of high psoriasis disease activity. Answer is multiple choice, self-reported. Ordinal data.
Measured: Through study completion, estimated to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start19 Oct 2022
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- Cross-sectional
- Enrolment
- 3,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, University of Copenhagen, Karolinska Institutet, Lund University
- Responsible party
- Principal investigator, Albert Duvetorp, Skane University Hospital
- Investigators
- Albert Duvetorp, MD PhD, Principal investigator, Lunds University, Copenhagen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589298
- Sponsor's protocol ID
- PSODEEP1
- Acronym
- PSODEEP1
- Status last verified
- Dec 2024
- First submitted
- 15 Oct 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared upon reasonable request if the correct legal arrangements can be set up (according to GDPR and data protection laws etc).
Publications
Weiss G, Shemer A, Trau H. The Koebner phenomenon: review of the literature. J Eur Acad Dermatol Venereol. 2002 May;16(3):241-8. doi: 10.1046/j.1473-2165.2002.00406.x.
PubMed 12195563Soltani-Arabshahi R, Wong B, Feng BJ, Goldgar DE, Duffin KC, Krueger GG. Obesity in early adulthood as a risk factor for psoriatic arthritis. Arch Dermatol. 2010 Jul;146(7):721-6. doi: 10.1001/archdermatol.2010.141.
PubMed 20644032Pattison E, Harrison BJ, Griffiths CE, Silman AJ, Bruce IN. Environmental risk factors for the development of psoriatic arthritis: results from a case-control study. Ann Rheum Dis. 2008 May;67(5):672-6. doi: 10.1136/ard.2007.073932. Epub 2007 Sep 6.
PubMed 17823200
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire on Self-reported Experience of Koebner and Deep-Koebner Phenomenon in Patients With Psoriasis and Psoriatic Arthritis.
- ClinicalTrials.gov ID
- NCT05589298
- Acronym / sponsor ID
- PSODEEP1 / PSODEEP1
- Keywords
- Koebner, Deep-Koebner, Psoriasis, Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,064 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- University of Chile, University of Copenhagen, Karolinska Institutet, Lund University
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 21 Oct 2022 (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.
PSODEEP 1 is a descriptive digital interview study where we intend to include at least 900 individuals. Individuals with known psoriasis or known psoriatic arthritis will access the digital interview via a QR code distributed via their rheumatology or dermatology department using their smartphones. Data on answers results are stored digitally and can be accessed parallel to recruitment. Questions focus on following fields (all self reported): background information (age/sex), disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.
Detailed description
PSODEEP1 is a descriptive digital interview study. Questions on self reported experience of following fields will be stated: background information, disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.
Questions will be distributed using REDCap (REsearch Electronic Data CAPture) platform provided by Lunds university, University of Santiago and Copenhagen University (www.project-redcap.org). Patients with known psoriasis or psoriatic arthritis will reach the questionnaire using a QR-code on patient's information sheet distributed in clinical settings. In Sweden, patients will be recruited at dermatology and rheumatology outpatient clinics in Malmö, Lund, Göteborg, Örebro, Stockholm (Skåne University Hospital, Karolinska Hospital, Sahlgrenska Hospital, Ryhov Hospital, Örebro, Hospital). In Chile patients will be recruited at Hospital Clínico Universidad de Chile and CIEC-PMR Centro Internacional de Estudios Clínicos - Probity Medical Research. In Denmark, patients will be recruited at Gentofte Hospital and through Leo foundation skin immunology research center (Copenhagen University) and the Parker Institute.
Study inclusion criteria: Physician diagnosed psoriasis, psoriatic arthritis or both. Age of 18 years or older. Ability to comprehend instructions and read the Swedish, Spanish or Danish language (according to country). Having a smartphone with which one can access the study questions using a QR code. Study exclusion criteria: Having participated in the study already. Not having a mobile telephone number (used to identify duplicate answers).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PSODEEP1 Sweden | – | –Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Sweden. |
| PSODEEP1 Denmark | – | –Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Denmark. |
| PSODEEP1 Chile | – | –Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Chile. |
| PSODEEP1 Netherlands | – | –Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in the Netherlands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with psoriasis and/or psoriatic arthritis
Key inclusion criteria (5 listed)
- MD diagnosis of psoriasis and/or psoriasis arthritis
- Age over 18 years
- Ability to read and understand written questions
- Having/ability to use smartphone
- Given consent
Key exclusion criteria (1 listed)
- Having participated previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Koebner
Time frame: Through study completion, estimated to 12 months.
Occurence of Self-Reported Koebner phenomena. Self-reported in multiple choice questionnaire "Has your skin psoriasis ever developed at the site of a skin injury, such as a scrape or a burn?" YES/NO/DO NOT KNOW. Ordinal data.
Trauma induced Deep-Koebner
Time frame: Through study completion, estimated to 12 months.
Occurence of Self-Reported trauma induced Deep-Koebner phenomena in patients with with psoriasis arthritis. Questionnaire, self-reported, multiple choice "Have you ever developed psoriatic arthritis in a joint after injury, e.g. after a fall or sprain? " YES/NO/DO NOT KNOW. Ordinal data.
2 secondary outcomes
Variation in Koebner
Time frame: Through study completion, estimated to 12 months.
Variation in Trauma induced Deep-Koebner
Time frame: Through study completion, estimated to 12 months.
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 4 Dec 2024.
- Background: PubMed 12195563Weiss G, Shemer A, Trau H. The Koebner phenomenon: review of the literature. J Eur Acad Dermatol Venereol. 2002 May;16(3):241-8. doi: 10.1046/j.1473-2165.2002.00406.x.
- Background: PubMed 20644032Soltani-Arabshahi R, Wong B, Feng BJ, Goldgar DE, Duffin KC, Krueger GG. Obesity in early adulthood as a risk factor for psoriatic arthritis. Arch Dermatol. 2010 Jul;146(7):721-6. doi: 10.1001/archdermatol.2010.141.
- Background: PubMed 17823200Pattison E, Harrison BJ, Griffiths CE, Silman AJ, Bruce IN. Environmental risk factors for the development of psoriatic arthritis: results from a case-control study. Ann Rheum Dis. 2008 May;67(5):672-6. doi: 10.1136/ard.2007.073932. Epub 2007 Sep 6.
- Individual participant dataSharing planned: Undecided. Data can be shared upon reasonable request if the correct legal arrangements can be set up (according to GDPR and data protection laws etc).
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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.
Albert Duvetorp, MD PhD principal investigator
Lunds University, Copenhagen University
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 and Psoriasis; Arthritis (Etiology), run by Skane University Hospital at 1 site in Sweden.
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 5 inclusion and 1 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 4 Dec 2024. 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 Sweden. 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?
Koebner (time frame: Through study completion, estimated to 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589298, which also lists 3 linked publications.
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 4 Dec 2024.