Koebner's Phenomenon in Psoriasis and Lichen Planus

Psoriasis Clinical Trial

— RENBOEK  

Official title:

A Prospective Study to Investigate the Pathophysiology of the Koebner's Phenomenon in Psoriasis and Lichen Planus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06021405
• Other study ID #: 2023-00427
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: University of Zurich
• Contact: Marie-Charlotte Brüggen, MD PhD
• Phone: +41 44 255 1111
• Email: marie-charlotte.brueggen[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psoriasis and lichen planus often occur at mechanically irritated skin sites (e.g. tight clothing). The investigators would like to investigate this phenomenon in more detail in this study. For this purpose, the skin is specifically irritated at a small and cosmetically favorable site by tearing off scotch tape or rubbing with a wooden spatula. In order to be able to examine the inflammatory processes caused by the irritation more closely, a small skin sample and a skin swab are taken from the irritated area. This skin sample and the swab are repeated after three and fourteen days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 30, 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Dermatologist diagnosed psoriasis (group psoriasis), lichen planus (group lichen planus) or no skin disease (group healthy controls)

• Subject is capable of giving informed consent

• Signed informed consent

Exclusion Criteria:

• Use of systemic immunosuppressive/immunmodulating agents in the last three months

• Use of topical anti-inflammatory treatment in the last 7 days in the area of sampling.

• Phototherapy in the last 4 weeks

• Active or recurrent serious bacterial, fungal or viral infection at the time of enrollment by patient history, including patients with Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.

• Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial

• Known or suspected non-compliance, drug or alcohol abuse,

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

• Previous enrolment into the current study,

• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Related Conditions & MeSH terms

• Lichen Planus
• Psoriasis

Intervention

Procedure:
• Tape stripping
a small area of skin will be tape-stripped with adhesive tape for up to 40 times and/or rubbed with a wooden spatula until the skin shows a slight erythema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marie-Charlotte Brüggen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon	Transcriptomic profile at all timepoints (reads per 55µm diameter dot)	Day 0, Day 3 (optional), Day 14 (optional)
Secondary	Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon	Olink multiplex proteomics analysis at all timepoints	Day 0, Day 3 (optional), Day 14 (optional)
Secondary	Characterization of involved immune cells in the skin comparing psoriasis patients with and without induced koebner phenomenon	Imaging mass cytometry (skin biopsies) at all timepoints	Day 0, Day 3 (optional), Day 14 (optional)
Secondary	Characterization of skin mikrobiome	Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA	Day 0, Day 3, Day 14