The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis

Psoriasis Clinical Trial

— PSODEEP1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589298
• Other study ID #: PSODEEP1
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: October 17, 2024

Study information

• Verified date: February 2023
• Source: Skane University Hospital
• Contact: Albert Duvetorp, MD PhD
• Phone: +460736166946
• Email: albert.duvetorp[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 17, 2024
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis

Locations

Country	Name	City	State
Sweden	Hudkliniken Skånes Universitetssjukhus	Malmö	Skåne

Sponsors (5)

Lead Sponsor	Collaborator
Skane University Hospital	Karolinska Institutet, Lund University, University of Chile, University of Copenhagen

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Worsening of psoriasis due to scratching	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.
Other	Variation in worsening of psoriasis due to scratching over time	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.
Other	Presence of symptoms that could imply presence of psoriatic arthritis.	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.
Primary	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.
Primary	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	Variation in Koebner	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.
Secondary	Variation in Trauma induced Deep-Koebner	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.