RENBOEK: Koebner's Phenomenon in Psoriasis and Lichen Planus

Sponsor
Marie-Charlotte Brüggen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06021405
Collaborator
(none)
70
1
21.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tape stripping
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Prospective Study to Investigate the Pathophysiology of the Koebner's Phenomenon in Psoriasis and Lichen Planus
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 24, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tape stripping

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

Outcome Measures

Primary Outcome Measures

  1. Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon [Day 0, Day 3 (optional), Day 14 (optional)]

    Transcriptomic profile at all timepoints (reads per 55µm diameter dot)

Secondary Outcome Measures

  1. Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon [Day 0, Day 3 (optional), Day 14 (optional)]

    Olink multiplex proteomics analysis at all timepoints

  2. Characterization of involved immune cells in the skin comparing psoriasis patients with and without induced koebner phenomenon [Day 0, Day 3 (optional), Day 14 (optional)]

    Imaging mass cytometry (skin biopsies) at all timepoints

  3. Characterization of skin mikrobiome [Day 0, Day 3, Day 14]

    Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Marie-Charlotte Brüggen

Investigators

  • Principal Investigator: Marie-Charlotte Brüggen, MD PhD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie-Charlotte Brüggen, Prof. Dr. med. PhD, University of Zurich
ClinicalTrials.gov Identifier:
NCT06021405
Other Study ID Numbers:
  • 2023-00427
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2023