The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis (PSODEEP1)

December 2, 2024 updated by: Albert Duvetorp, Skane University Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3064

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden, 20502
        • Hudkliniken Skånes Universitetssjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with psoriasis and/or psoriatic arthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, estimated to 12 months.
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.
Through study completion, estimated to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, estimated to 12 months.
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.
Through study completion, estimated to 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, estimated to 12 months.
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.
Through study completion, estimated to 12 months.
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.
Through study completion, estimated to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skane University Hospital

Collaborators

Karolinska Institutet
Lund University
University of Copenhagen
University of Chile

Investigators

  • Principal Investigator: Albert Duvetorp, MD PhD, Lunds University, Copenhagen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSODEEP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data can be shared upon reasonable request if the correct legal arrangements can be set up (according to GDPR and data protection laws etc).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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