<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/NCT03242577</url>
  </required_header>
  <id_info>
    <org_study_id>500-17-07</org_study_id>
    <nct_id>NCT03242577</nct_id>
  </id_info>
  <brief_title>Micro-Technique Sampling</brief_title>
  <official_title>An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kimberly-Clark Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kimberly-Clark Corporation</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>
      This is a single-center, exploratory comparative pilot study to identify the most appropriate&#xD;
      method for microbial consortia sampling from the skin.&#xD;
&#xD;
      Ten subjects are expected to complete the study at one investigative site in the United&#xD;
      States.&#xD;
&#xD;
      The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1,&#xD;
      subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be&#xD;
      combined into one visit. Visit 1 will involve the informed consent process, screening, and&#xD;
      enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3)&#xD;
      different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape&#xD;
      stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a&#xD;
      laboratory for analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 2, 2017</completion_date>
  <primary_completion_date type="Actual">August 2, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Best method for collecting skin microbiome samples</measure>
    <time_frame>1 day</time_frame>
    <description>Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Dermatitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will consist of ten (10)Caucasian female adults 18-40 years of age, at 1 US site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fluent in English, willing and able to read, understand, and sign the informed consent&#xD;
             form (ICF);&#xD;
&#xD;
          -  Ability to complete the course of the study and comply with instructions;&#xD;
&#xD;
          -  Females aged 18 to 40 years, in good general health as deemed by the investigator (no&#xD;
             physical required);&#xD;
&#xD;
          -  Individuals free of any systemic or dermatological disorder, tatoos in the testing&#xD;
             area or recent tanning bed exposure&#xD;
&#xD;
          -  Anticipated ability to complete the course of the study and to comply with&#xD;
             instructions;&#xD;
&#xD;
          -  Females practicing an acceptable method of birth control&#xD;
&#xD;
          -  Caucasian individuals with Fitzpatrick skin type I, II, or III&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Barry Reece</last_name>
    <role>Principal Investigator</role>
    <affiliation>RCTs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Reliance Clinical Testing Services</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</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>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Subjects will be identified on logs and other documents submitted to the Sponsor by their unique identification number with or without their initials, not by name. Documents that identify the subject (e.g., the signed informed consent) are not to be submitted to the Sponsor and must be maintained in confidence by the Investigator.</ipd_description>
  </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/NCT03242577
org study id: 500-17-07
nct id: NCT03242577
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center, exploratory comparative pilot study to identify the most appropriate
      method for microbial consortia sampling from the skin.

      Ten subjects are expected to complete the study at one investigative site in the United
      States.

      The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1,
      subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be
      combined into one visit. Visit 1 will involve the informed consent process, screening, and
      enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3)
      different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape
      stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a
      laboratory for analysis.
observational model: Other
time perspective: Cross-Sectional
measure: Best method for collecting skin microbiome samples
time frame: 1 day
description: Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
last name: Barry Reece
role: Principal Investigator
affiliation: RCTs
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
sharing ipd: No
ipd description: Subjects will be identified on logs and other documents submitted to the Sponsor by their unique identification number with or without their initials, not by name. Documents that identify the subject (e.g., the signed informed consent) are not to be submitted to the Sponsor and must be maintained in confidence by the Investigator.