<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/NCT03795402</url>
  </required_header>
  <id_info>
    <org_study_id>8004053</org_study_id>
    <secondary_id>8004053</secondary_id>
    <nct_id>NCT03795402</nct_id>
  </id_info>
  <brief_title>Analysis of Non-Invasively Collected Microneedle Device Samples From Mild Plaque Psoriasis for Use in Transcriptomics Profiling</brief_title>
  <official_title>Collection of Skin Punch Biopsies and Non-Invasively Collected Microneedle Device Samples From Subjects With Mild Chronic Plaque Psoriasis Vulgaris to Use for Transcriptomics Profiling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovaderm Research Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect skin biopsies and non-invasive microneedle device&#xD;
      samples from participants with mild chronic plaque psoriasis vulgaris to use for&#xD;
      transcriptomics profiling for further investigation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">December 6, 2019</completion_date>
  <primary_completion_date type="Actual">November 25, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Measurement of expression by ribonucleic acid (RNA)-sequencing of extracted RNA by the frequently used punch biopsy method and the microneedle device will be performed to have a comparison between both the methods.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Three microneedle device samples will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1. Two skin biopsies of 4 millimeter (mm) will be performed on Day 1. No investigational drug product will be administered during this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>One microneedle device sample will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1 and at Weeks 2 and 4. Two skin biopsies of 4 mm will be performed on Day 1. No investigational drug product will be administered during this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microneedle Device</intervention_name>
    <description>Microneedle device will be used for collecting skin samples as a non-invasive method.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with mild chronic plaque psoriasis vulgaris, defined as having a body surface&#xD;
        area (BSA) greater than or equal to (&gt;=) 1 percent (%) and less than (&lt;) 10% (excluding&#xD;
        palms, soles, face, scalp, and genitals), will be included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has a history of chronic plaque psoriasis vulgaris for at least 6 months&#xD;
             prior to the screening visit&#xD;
&#xD;
          -  Participant has had stable psoriasis conditions for at least 3 months before screening&#xD;
             (information obtained from medical chart or participant's physician, or directly from&#xD;
             the participant)&#xD;
&#xD;
          -  Participant has plaque psoriasis covering &gt;= 1% but &lt; 10% of his total BSA on Day 1&#xD;
&#xD;
          -  For Group A: Participant has one psoriasis target lesion or individual lesions within&#xD;
             the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a&#xD;
             target lesion severity score (TLSS) score of &gt;= 6 on Day 1 allowing the collection of&#xD;
             three microneedle device samples and one biopsy sample&#xD;
&#xD;
          -  For Group B: Participant has one psoriasis target lesion or individual lesions within&#xD;
             the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a&#xD;
             TLSS score of &gt;= 6 on Day 1 allowing the collection of one microneedle device sample&#xD;
             per visit (replicating the extraction on the same area at each visit) and one biopsy&#xD;
             sample&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant is a female who is breastfeeding, pregnant, or who is planning to become&#xD;
             pregnant during the study&#xD;
&#xD;
          -  Participant has evidence of erythrodermic, pustular, predominantly guttate psoriasis,&#xD;
             or drug-induced psoriasis&#xD;
&#xD;
          -  Participant has a history of skin disease or presence of skin condition that, in the&#xD;
             opinion of the investigator, would interfere with the sample collection or&#xD;
             interpretation&#xD;
&#xD;
          -  Participant is known to have immune deficiency or is immunocompromised&#xD;
&#xD;
          -  Participant has a history of cancer or lymphoproliferative disease within 5 years&#xD;
             prior to Day 1. Participants with successfully treated nonmetastatic cutaneous&#xD;
             squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix&#xD;
             are not to be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innovaderm Research Inc.</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2K 4L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>December 12, 2019</last_update_submitted>
  <last_update_submitted_qc>December 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03795402
org study id: 8004053
secondary id: 8004053
nct id: NCT03795402
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to collect skin biopsies and non-invasive microneedle device
      samples from participants with mild chronic plaque psoriasis vulgaris to use for
      transcriptomics profiling for further investigation.
observational model: Cohort
time perspective: Prospective
measure: Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method
time frame: Up to 28 days
description: Measurement of expression by ribonucleic acid (RNA)-sequencing of extracted RNA by the frequently used punch biopsy method and the microneedle device will be performed to have a comparison between both the methods.
arm group label: Group A
description: Three microneedle device samples will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1. Two skin biopsies of 4 millimeter (mm) will be performed on Day 1. No investigational drug product will be administered during this study.
arm group label: Group B
description: One microneedle device sample will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1 and at Weeks 2 and 4. Two skin biopsies of 4 mm will be performed on Day 1. No investigational drug product will be administered during this study.
intervention type: Device
intervention name: Microneedle Device
description: Microneedle device will be used for collecting skin samples as a non-invasive method.
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No