MedDataX Logo

The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis

NCT ID: NCT05589298

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3064 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-19

Study Completion Date

2024-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Psoriasis; Arthritis (Etiology) Koebner Phenomenon

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PSODEEP1 Sweden

Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Sweden.

No interventions assigned to this group

PSODEEP1 Denmark

Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Denmark.

No interventions assigned to this group

PSODEEP1 Chile

Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Chile.

No interventions assigned to this group

PSODEEP1 Netherlands

Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in the Netherlands.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Chile

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Albert Duvetorp

Principal Investigator, Head of Psoriasis outpatient clinic Malmö, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Albert Duvetorp, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lunds University, Copenhagen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hudkliniken Skånes Universitetssjukhus

Malmo, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12195563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20644032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17823200 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSODEEP1

Identifier Type: -

Identifier Source: org_study_id