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/NCT05994976</url>
    </required_header>
    <id_info>
      <org_study_id>INNO-5034</org_study_id>
      <nct_id>NCT05994976</nct_id>
    </id_info>
    <brief_title>Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers</brief_title>
    <official_title>Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Innovaderm Research Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Innovaderm Research Inc.</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 the study is to collect different samples for molecular characterization of&#xD;
        inflammatory skin diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is being conducted to collect samples from subjects with various skin conditions&#xD;
        as well as healthy volunteers. Collected samples may be used for different analyses&#xD;
        including, but not limited to, biomarker and gene expression analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2028</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Exploratory biomarker and gene expression analyses.</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Untargeted biomarker approach with gene expression profile of skin samples</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <number_of_groups>7</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Acne</condition>
    <condition>Atopic Dermatitis</condition>
    <condition>Chronic Hand Eczema</condition>
    <condition>Hidradenitis Suppurativa</condition>
    <condition>Plaque Psoriasis</condition>
    <condition>Palmoplantar Pustulosis</condition>
    <arm_group>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <description>Healthy adults</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Acne</arm_group_label>
      <description>Adult subjects aged 18 to 45 years old with acne</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AD</arm_group_label>
      <description>Adult subjects with Atopic Dermatitis (AD)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CHE</arm_group_label>
      <description>Adult subjects with Chronic Hand Eczema (CHE)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HS</arm_group_label>
      <description>Adult subjects with Hidradenitis suppurativa (HS)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PPP</arm_group_label>
      <description>Adult subjects with Palmoplantar pustulosis (PPP)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Psoriasis</arm_group_label>
      <description>Adult subjects with Psoriasis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Blood samples collection</intervention_name>
      <description>biomarkers and optional genetic analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Oral samples collection</intervention_name>
      <description>biomarkers analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Hair samples collection</intervention_name>
      <description>biomarkers analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)</intervention_name>
      <description>biomarkers analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Skin surface material samples</intervention_name>
      <description>biomarkers analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Drainage fluid samples collection</intervention_name>
      <description>biomarkers analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Stool samples collection</intervention_name>
      <description>biomarkers analysis</description>
      <arm_group_label>AD</arm_group_label>
      <arm_group_label>Acne</arm_group_label>
      <arm_group_label>CHE</arm_group_label>
      <arm_group_label>HS</arm_group_label>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>PPP</arm_group_label>
      <arm_group_label>Psoriasis</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, stool, saliva, skin sample, lipid, sebum, microbiome, microorganism, hair, draining&#xD;
        fluid&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Approximately 200 healthy volunteers and approximately 300 subjects with acne, atopic&#xD;
          dermatitis (AD), chronic hand eczema (CHE), hidradenitis suppurativa (HS), palmoplantar&#xD;
          pustulosis (PPP), and/or psoriasis will be included in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All subjects:&#xD;
  &#xD;
            1. Subject is willing to participate and is capable of giving informed consent. Note:&#xD;
               Consent must be obtained prior to any study-related procedures.&#xD;
  &#xD;
            2. Subject must be willing to comply with all study procedures and must be available for&#xD;
               the duration of the study.&#xD;
  &#xD;
               Healthy volunteers:&#xD;
  &#xD;
            3. Male or female subject aged 18 years or older, at the time of consent.&#xD;
  &#xD;
            4. Subject is in good general health, according to the investigator's judgment.&#xD;
  &#xD;
               Subjects with Acne:&#xD;
  &#xD;
            5. Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.&#xD;
  &#xD;
               Subjects with AD:&#xD;
  &#xD;
            6. Male or female subject aged 18 years or older, at the time of consent.&#xD;
  &#xD;
            7. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and&#xD;
               Rajka criteria.&#xD;
  &#xD;
               Subjects with CHE:&#xD;
  &#xD;
            8. Male or female subject aged 18 years or older, at the time of consent.&#xD;
  &#xD;
            9. Subject has at least a 6-month history of CHE before Screening (information obtained&#xD;
               from medical chart or subject's physician, or directly from the subject).&#xD;
  &#xD;
               Subjects with HS:&#xD;
  &#xD;
           10. Male or female subject aged 18 years or older, at the time of consent.&#xD;
  &#xD;
           11. Subject has a clinically confirmed diagnosis of active HS with a disease duration of ≥&#xD;
               6 months before screening as determined by the investigator through subject interview&#xD;
               and/or review of the medical history.&#xD;
  &#xD;
               Subjects with PPP:&#xD;
  &#xD;
           12. Male or female subject aged 18 years or older at the time of consent.&#xD;
  &#xD;
           13. Subject has at least a 6-month history of PPP as defined by the presence of pustules&#xD;
               on palms and/or soles, but without evidence of infection on palms and soles&#xD;
               (information obtained from medical chart or subject's physician, or directly from the&#xD;
               subject).&#xD;
  &#xD;
               Subjects with psoriasis:&#xD;
  &#xD;
           14. Male or female subject aged 18 years or older, at the time of consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          All subjects:&#xD;
  &#xD;
            1. Subject is a female who is pregnant or who is planning to become pregnant during the&#xD;
               study.&#xD;
  &#xD;
            2. Subject has a history of skin disease or presence of skin condition that, in the&#xD;
               opinion of the investigator, would interfere with the study assessments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert Bissonnette, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Innovaderm Research Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Julie Bedoucha, MSc</last_name>
      <phone>514-521-4285</phone>
      <phone_ext>253</phone_ext>
      <email>jbedoucha@innovaderm.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Innovaderm Research Inc.</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H2X 2V1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Julie Bedoucha, MSc</last_name>
        <phone>514-521-4285</phone>
        <phone_ext>253</phone_ext>
        <email>jbedoucha@innovaderm.com</email>
      </contact>
      <investigator>
        <last_name>Robert Bissonnette, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>Hidradenitis Suppurativa</mesh_term>
      <mesh_term>Psoriasis</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Hidradenitis</mesh_term>
      <mesh_term>Skin Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05994976
  org study id: INNO-5034
  nct id: NCT05994976
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to collect different samples for molecular characterization of
        inflammatory skin diseases.
  This study is being conducted to collect samples from subjects with various skin conditions
        as well as healthy volunteers. Collected samples may be used for different analyses
        including, but not limited to, biomarker and gene expression analyses.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Exploratory biomarker and gene expression analyses.
  time frame: Day 1
  measure: Untargeted biomarker approach with gene expression profile of skin samples
  time frame: Day 1
  arm group label: Healthy volunteers
  description: Healthy adults
  arm group label: Acne
  description: Adult subjects aged 18 to 45 years old with acne
  arm group label: AD
  description: Adult subjects with Atopic Dermatitis (AD)
  arm group label: CHE
  description: Adult subjects with Chronic Hand Eczema (CHE)
  arm group label: HS
  description: Adult subjects with Hidradenitis suppurativa (HS)
  arm group label: PPP
  description: Adult subjects with Palmoplantar pustulosis (PPP)
  arm group label: Psoriasis
  description: Adult subjects with Psoriasis
  intervention type: Procedure
  intervention name: Blood samples collection
  description: biomarkers and optional genetic analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  intervention type: Procedure
  intervention name: Oral samples collection
  description: biomarkers analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  intervention type: Procedure
  intervention name: Hair samples collection
  description: biomarkers analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  intervention type: Procedure
  intervention name: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
  description: biomarkers analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  intervention type: Procedure
  intervention name: Skin surface material samples
  description: biomarkers analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  intervention type: Procedure
  intervention name: Drainage fluid samples collection
  description: biomarkers analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  intervention type: Procedure
  intervention name: Stool samples collection
  description: biomarkers analysis
  arm group label: AD
  arm group label: Acne
  arm group label: CHE
  arm group label: HS
  arm group label: Healthy volunteers
  arm group label: PPP
  arm group label: Psoriasis
  Blood, stool, saliva, skin sample, lipid, sebum, microbiome, microorganism, hair, draining
        fluid
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robert Bissonnette, MD
  role: Principal Investigator
  affiliation: Innovaderm Research Inc.
  last name: Julie Bedoucha, MSc
  phone: 514-521-4285
  phone ext: 253
  email: jbedoucha@innovaderm.com
  facility: 
  contact: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Hidradenitis Suppurativa
  mesh term: Psoriasis
  mesh term: Dermatitis
  mesh term: Hidradenitis
  mesh term: Skin Diseases
  sharing ipd: No