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

Primary Purpose

Kobner Phenomenon, Psoriasis, Lichen Planus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tape stripping
Sponsored by
Marie-Charlotte Brüggen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kobner Phenomenon

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tape stripping

    Arm Description

    Outcomes

    Primary Outcome Measures

    Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon
    Transcriptomic profile at all timepoints (reads per 55µm diameter dot)

    Secondary Outcome Measures

    Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon
    Olink multiplex proteomics analysis at all timepoints
    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
    Characterization of skin mikrobiome
    Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA

    Full Information

    First Posted
    August 11, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Marie-Charlotte Brüggen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06021405
    Brief Title
    Koebner's Phenomenon in Psoriasis and Lichen Planus
    Acronym
    RENBOEK
    Official Title
    A Prospective Study to Investigate the Pathophysiology of the Koebner's Phenomenon in Psoriasis and Lichen Planus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    December 24, 2024 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Marie-Charlotte Brüggen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kobner Phenomenon, Psoriasis, Lichen Planus

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tape stripping
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Tape stripping
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon
    Description
    Transcriptomic profile at all timepoints (reads per 55µm diameter dot)
    Time Frame
    Day 0, Day 3 (optional), Day 14 (optional)
    Secondary Outcome Measure Information:
    Title
    Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon
    Description
    Olink multiplex proteomics analysis at all timepoints
    Time Frame
    Day 0, Day 3 (optional), Day 14 (optional)
    Title
    Characterization of involved immune cells in the skin comparing psoriasis patients with and without induced koebner phenomenon
    Description
    Imaging mass cytometry (skin biopsies) at all timepoints
    Time Frame
    Day 0, Day 3 (optional), Day 14 (optional)
    Title
    Characterization of skin mikrobiome
    Description
    Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA
    Time Frame
    Day 0, Day 3, Day 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marie-Charlotte Brüggen, MD PhD
    Phone
    +41 44 255 1111
    Email
    marie-charlotte.brueggen@usz.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marie-Charlotte Brüggen, MD PhD
    Organizational Affiliation
    University of Zurich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Koebner's Phenomenon in Psoriasis and Lichen Planus

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