Clinical trial NCT05589298: The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis
Official title: Questionnaire on Self-reported Experience of Koebner and Deep-Koebner Phenomenon in Patients With Psoriasis and Psoriatic Arthritis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Psoriasis; Arthritis (Etiology)
Koebner Phenomenon
Keywords: Koebner
Deep-Koebner
Psoriasis
Arthritis
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: University of Chile
name: University of Copenhagen
name: Karolinska Institutet
name: Lund University
First posted: 2022-10-21
Enrollment: 3064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with psoriasis and/or psoriatic 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).

Eligibility criteria: 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

Primary outcomes:
measure: Koebner
timeFrame: Through study completion, estimated to 12 months.
measure: Trauma induced Deep-Koebner
timeFrame: Through study completion, estimated to 12 months.
Secondary outcomes:
measure: Variation in Koebner
timeFrame: Through study completion, estimated to 12 months.
measure: Variation in Trauma induced Deep-Koebner
timeFrame: Through study completion, estimated to 12 months.
Other outcomes:
measure: Worsening of psoriasis due to scratching
timeFrame: Through study completion, estimated to 12 months.
measure: Variation in worsening of psoriasis due to scratching over time
timeFrame: Through study completion, estimated to 12 months.
measure: Presence of symptoms that could imply presence of psoriatic arthritis.
timeFrame: Through study completion, estimated to 12 months.
Locations:
city: Malmö
country: Sweden
facility: Hudkliniken Skånes Universitetssjukhus
state: Skåne
Study officials:
affiliation: Lunds University, Copenhagen University
name: Albert Duvetorp, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Soltani-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.
citation: Pattison 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.