NCT05589298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,064

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

October 15, 2022

Last Update Submit

December 2, 2024

Conditions

Keywords

KoebnerDeep-KoebnerPsoriasisArthritis

Outcome Measures

Primary Outcomes (2)

  • Koebner

    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

    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 Outcomes (2)

  • Variation in Koebner

    Through study completion, estimated to 12 months.

  • Variation in Trauma induced Deep-Koebner

    Through study completion, estimated to 12 months.

Other Outcomes (3)

  • Worsening of psoriasis due to scratching

    Through study completion, estimated to 12 months.

  • Variation in worsening of psoriasis due to scratching over time

    Through study completion, estimated to 12 months.

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

    Through study completion, estimated to 12 months.

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with psoriasis and/or psoriatic arthritis

You may qualify if:

  • 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

You may not qualify if:

  • \- Having participated previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hudkliniken Skånes Universitetssjukhus

Malmo, Skåne County, 20502, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 12195563BACKGROUND
  • 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.

    PMID: 20644032BACKGROUND
  • 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.

    PMID: 17823200BACKGROUND

MeSH Terms

Conditions

PsoriasisArthritis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Albert Duvetorp, MD PhD

    Lunds University, Copenhagen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Psoriasis outpatient clinic Malmö, MD PhD

Study Record Dates

First Submitted

October 15, 2022

First Posted

October 21, 2022

Study Start

October 19, 2022

Primary Completion

February 14, 2024

Study Completion

February 14, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations