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The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis

Questionnaire on Self-reported Experience of Koebner and Deep-Koebner Phenomenon in Patients With Psoriasis and Psoriatic Arthritis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05589298
Acronym
PSODEEP1
Enrollment
3064
Registered
2022-10-21
Start date
2022-10-19
Completion date
2024-02-14
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Koebner Phenomenon, Psoriasis, Psoriasis; Arthritis (Etiology)

Keywords

Koebner, Deep-Koebner, Psoriasis, Arthritis

Brief 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. 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).

Interventions

None listed

Sponsors

University of Chile
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Lund University
CollaboratorOTHER
Skane University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\- Having participated previously

Design outcomes

Primary

MeasureTime frameDescription
KoebnerThrough 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-KoebnerThrough 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.

Secondary

MeasureTime frameDescription
Variation in KoebnerThrough study completion, estimated to 12 months.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.
Variation in Trauma induced Deep-KoebnerThrough study completion, estimated to 12 months.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.

Other

MeasureTime frameDescription
Variation in worsening of psoriasis due to scratching over timeThrough study completion, estimated to 12 months.Follow up question to participants that report worsening due to scratching. Multiple choice question in order to assess if this experience is constant or related to overall disease activity. Ordinal data.
Presence of symptoms that could imply presence of psoriatic arthritis.Through study completion, estimated to 12 months.Multiple choice questions in digital questionnaire assessing self-reported presence of dactylitis, nail-pitting, tendinitis and arthritis. Output is ordinal data.
Worsening of psoriasis due to scratchingThrough study completion, estimated to 12 months.Self-reported, multiple choice answer in questionnaire Does your skin psoriasis worsen due to scraping or scratching (e.g. secondary to itch)? YES/NO/DO NOT KNOW. Ordinal data.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026