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Completed

NCT Number: NCT05589298

The Study of Koebner 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.

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Key information

Conditions

Psoriasis Arthritis Joint Diseases Koebner Phenomenon Musculoskeletal Diseases Psoriasis; Arthritis (Etiology) Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hudkliniken Skånes Universitetssjukhus

Malmö, Skåne County, 20502, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Variation in Koebner

    Time frame: Through 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.

  2. Variation in Trauma induced Deep-Koebner

    Time frame: Through 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 outcomes

  1. Worsening of psoriasis due to scratching

    Time frame: Through 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.

  2. Variation in worsening of psoriasis due to scratching over time

    Time frame: Through 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.

  3. Presence of symptoms that could imply presence of psoriatic arthritis.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Karolinska Institutet
  • Lund University
  • University of Chile
  • University of Copenhagen

Registry information

Official study title

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

Acronym: PSODEEP1

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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