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Koebner's Phenomenon in Psoriasis and Lichen Planus (RENBOEK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06021405
Recruitment Status : Not yet recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Marie-Charlotte Brüggen, University of Zurich

Study Description
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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
Kobner Phenomenon Psoriasis Lichen Planus Procedure: Tape stripping Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : December 24, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 0, Day 3 (optional), Day 14 (optional) ]
    Imaging mass cytometry (skin biopsies) at all timepoints

  3. Characterization of skin mikrobiome [ Time Frame: Day 0, Day 3, Day 14 ]
    Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021405


Contacts
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Contact: Marie-Charlotte Brüggen, MD PhD +41 44 255 1111 marie-charlotte.brueggen@usz.ch

Sponsors and Collaborators
Marie-Charlotte Brüggen
Investigators
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Principal Investigator: Marie-Charlotte Brüggen, MD PhD University of Zurich
More Information
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Responsible Party: Marie-Charlotte Brüggen, Prof. Dr. med. PhD, University of Zurich
ClinicalTrials.gov Identifier: NCT06021405    
Other Study ID Numbers: 2023-00427
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Lichen Planus
Skin Diseases, Papulosquamous
Skin Diseases
Lichenoid Eruptions