xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021405</url>
    </required_header>
    <id_info>
      <org_study_id>2023-00427</org_study_id>
      <nct_id>NCT06021405</nct_id>
    </id_info>
    <brief_title>Koebner's Phenomenon in Psoriasis and Lichen Planus</brief_title>
    <acronym>RENBOEK</acronym>
    <official_title>A Prospective Study to Investigate the Pathophysiology of the Koebner's Phenomenon in Psoriasis and Lichen Planus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marie-Charlotte Brüggen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Zurich</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Psoriasis and lichen planus often occur at mechanically irritated skin sites (e.g. tight&#xD;
        clothing). The investigators would like to investigate this phenomenon in more detail in this&#xD;
        study. For this purpose, the skin is specifically irritated at a small and cosmetically&#xD;
        favorable site by tearing off scotch tape or rubbing with a wooden spatula. In order to be&#xD;
        able to examine the inflammatory processes caused by the irritation more closely, a small&#xD;
        skin sample and a skin swab are taken from the irritated area. This skin sample and the swab&#xD;
        are repeated after three and fourteen days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 24, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon</measure>
      <time_frame>Day 0, Day 3 (optional), Day 14 (optional)</time_frame>
      <description>Transcriptomic profile at all timepoints (reads per 55µm diameter dot)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon</measure>
      <time_frame>Day 0, Day 3 (optional), Day 14 (optional)</time_frame>
      <description>Olink multiplex proteomics analysis at all timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of involved immune cells in the skin comparing psoriasis patients with and without induced koebner phenomenon</measure>
      <time_frame>Day 0, Day 3 (optional), Day 14 (optional)</time_frame>
      <description>Imaging mass cytometry (skin biopsies) at all timepoints</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of skin mikrobiome</measure>
      <time_frame>Day 0, Day 3, Day 14</time_frame>
      <description>Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Kobner Phenomenon</condition>
    <condition>Psoriasis</condition>
    <condition>Lichen Planus</condition>
    <arm_group>
      <arm_group_label>Tape stripping</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Tape stripping</intervention_name>
      <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</description>
      <arm_group_label>Tape stripping</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Dermatologist diagnosed psoriasis (group psoriasis), lichen planus (group lichen&#xD;
               planus) or no skin disease (group healthy controls)&#xD;
  &#xD;
            -  Subject is capable of giving informed consent&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of systemic immunosuppressive/immunmodulating agents in the last three months&#xD;
  &#xD;
            -  Use of topical anti-inflammatory treatment in the last 7 days in the area of sampling.&#xD;
  &#xD;
            -  Phototherapy in the last 4 weeks&#xD;
  &#xD;
            -  Active or recurrent serious bacterial, fungal or viral infection at the time of&#xD;
               enrollment by patient history, including patients with Human Immunodeficiency Virus&#xD;
               (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent&#xD;
               tuberculosis.&#xD;
  &#xD;
            -  Female patients of childbearing potential who are pregnant or breast feeding or&#xD;
               planning a pregnancy during the duration of the trial and/or not practicing acceptable&#xD;
               birth control for the duration of the trial&#xD;
  &#xD;
            -  Known or suspected non-compliance, drug or alcohol abuse,&#xD;
  &#xD;
            -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
               psychological disorders, dementia, etc. of the participant,&#xD;
  &#xD;
            -  Previous enrolment into the current study,&#xD;
  &#xD;
            -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
               persons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marie-Charlotte Brüggen, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Zurich</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marie-Charlotte Brüggen, MD PhD</last_name>
      <phone>+41 44 255 1111</phone>
      <email>marie-charlotte.brueggen@usz.ch</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Zurich</investigator_affiliation>
      <investigator_full_name>Marie-Charlotte Brüggen</investigator_full_name>
      <investigator_title>Prof. Dr. med. PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psoriasis</mesh_term>
      <mesh_term>Lichen Planus</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021405
  org study id: 2023-00427
  nct id: NCT06021405
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Differences in the transcriptomic profile comparing psoriasis patients with and without induced koebner phenomenon
  time frame: Day 0, Day 3 (optional), Day 14 (optional)
  description: Transcriptomic profile at all timepoints (reads per 55µm diameter dot)
  measure: Differences in the proteomic profile comparing psoriasis patients with and without induced koebner phenomenon
  time frame: Day 0, Day 3 (optional), Day 14 (optional)
  description: Olink multiplex proteomics analysis at all timepoints
  measure: 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)
  description: Imaging mass cytometry (skin biopsies) at all timepoints
  measure: Characterization of skin mikrobiome
  time frame: Day 0, Day 3, Day 14
  description: Skin swabs at all timepoints, analyzed by isolation and sequencing of the microbial DNA
  arm group label: Tape stripping
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Tape stripping
  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
  arm group label: Tape stripping
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marie-Charlotte Brüggen, MD PhD
  role: Principal Investigator
  affiliation: University of Zurich
  last name: Marie-Charlotte Brüggen, MD PhD
  phone: +41 44 255 1111
  email: marie-charlotte.brueggen@usz.ch
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Zurich
  investigator full name: Marie-Charlotte Brüggen
  investigator title: Prof. Dr. med. PhD
  mesh term: Psoriasis
  mesh term: Lichen Planus