<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/NCT04495920</url>
  </required_header>
  <id_info>
    <org_study_id>2005367-150</org_study_id>
    <nct_id>NCT04495920</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Residual Antimicrobial Activity</brief_title>
  <official_title>Clinical Evaluation of the Residual Antimicrobial Activity of One Test Product Based on the ASTM E2752 Test Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CAGE Bio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioScience Laboratories, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CAGE Bio Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</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 evaluate the residual antimicrobial efficacy of one test&#xD;
      product as defined by the difference between the number of a challenge bacterial species&#xD;
      recovered following exposure to the test product and the number recovered when untreated&#xD;
      (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC&#xD;
      #6538) (S. aureus). Testing will be carried out using a modification of the standardized test&#xD;
      method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual&#xD;
      Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be&#xD;
      assayed after application oftest material, using the forearms as a substrate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this&#xD;
      study, and will use the test product on one arm, and have the other arm untreated as the&#xD;
      negative control. The test sites on both forearms will be inoculated with suspensions&#xD;
      containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product&#xD;
      drying time, and at approximately 2 hours and 4 hours following test material applications.&#xD;
      The test sites will be sampled using the cup scrub procedure approximately 20 minutes&#xD;
      following each inoculation. The log 10 microbial recoveries of treated versus untreated sites&#xD;
      will be the basis for assessing the residual antimicrobial effectiveness of the test product.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">July 28, 2020</completion_date>
  <primary_completion_date type="Actual">July 13, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Significant Log 10 Microbial Change 4 hours post application</measure>
    <time_frame>4 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Bacterial Overgrowth</condition>
  <arm_group>
    <arm_group_label>Test product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CGB-S-100</intervention_name>
    <description>Alcohol and choline geranate</description>
    <arm_group_label>Test product</arm_group_label>
    <other_name>IonLAST gel (CGB-S-100 gel)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.&#xD;
&#xD;
          2. Subjects must possess both forearms.&#xD;
&#xD;
          3. Subjects must have no active skin rashes, dermatoses, or breaks in the skin of the&#xD;
             hands or forearms. Subjects must also have no inflammatory skin conditions, such as&#xD;
             atopic dermatitis eczema or psoriasis, anywhere on the body&#xD;
&#xD;
          4. Subjects must be in good general health and have no medical diagnosis of a physical&#xD;
             condition, such as a current or recent severe illness, a heart murmur, mitral valve&#xD;
             prolapse with heart murmur, congenital heart disease, an organ transplant, medicated&#xD;
             or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition&#xD;
             such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's&#xD;
             disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.&#xD;
&#xD;
          5. Subjects must have read and signed an Informed Consent Form, Authorization to Use and&#xD;
             Disclose Protected Health Information Form, and List of Restricted Products.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical study in the past 7 days or current participation in&#xD;
             another clinical study.&#xD;
&#xD;
          2. Experiencing any signs/symptoms of respiratory illness, including cough, fever (body&#xD;
             temperature of &gt;100.0 °F) or chills, shortness of breath or difficulty breathing,&#xD;
             persistent pain or pressure in the chest, confusion or inability to respond to&#xD;
             external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal&#xD;
             discharge (&quot;runny nose&quot;), frequent sneezing, or general fatigue I body aches.&#xD;
&#xD;
          3. Current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close&#xD;
             contact within the last 2 weeks of anyone who has been diagnosed as having contracted&#xD;
             COVID-19.&#xD;
&#xD;
          4. Travel outside of the state of Montana within the last two weeks.&#xD;
&#xD;
          5. History of smoking or vaping within the last 2 years.&#xD;
&#xD;
          6. Have known allergies or sensitivities to latex (natural rubber), metals, inks,&#xD;
             sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, or common&#xD;
             antibacterial agents, particularly, chlorhexidine gluconate (CHG), ethyl alcohol, and&#xD;
             isopropyl alcohol or topical antibiotic ointments (e.g., Neosporin® or Polysporin®).&#xD;
&#xD;
          7. Have experienced hives (raised welts) as a reaction to anything that contacted your&#xD;
             skin, with the exception of plants known to cause reactions for most humans (e.g.,&#xD;
             poison oak or poison ivy).&#xD;
&#xD;
          8. Be receiving any topical or systemic antibiotic medications during the 72-hour&#xD;
             pre-test conditioning period or on the test day.&#xD;
&#xD;
          9. Be receiving any steroids (including steroid medications used to treat asthma) other&#xD;
             than for contraception, hormone therapy, or menopausal purposes during the 72-hour&#xD;
             pre-test conditioning period or on the test day.&#xD;
&#xD;
         10. Have any prosthetic joints anywhere in the body or any (pins, screws, plates, rods, or&#xD;
             dental implants) anywhere in the body.&#xD;
&#xD;
         11. Have any type of port (or po1iacath) or Peripherally Insetied Central Catheter (PICC).&#xD;
&#xD;
         12. Be nursing a child.&#xD;
&#xD;
         13. Be pregnant, or have plans to become pregnant or impregnate a sexual partner once you&#xD;
             have consented to test in this study or during the test period.&#xD;
&#xD;
         14. Any medical condition or use of any medications that, in the opinion of the Principal&#xD;
             Investigator, or Consulting Physician should preclude patiicipation.&#xD;
&#xD;
         15. Unwillingness to fulfill the performance requirements of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Scientist</last_name>
    <role>Principal Investigator</role>
    <affiliation>BIOSCIENCE LAB ORA TORIES, INC.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bioscience Laboratories, Inc.</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Residual</keyword>
  <keyword>ASTME2752</keyword>
  <keyword>Antimicrobial</keyword>
  <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/NCT04495920
org study id: 2005367-150
nct id: NCT04495920
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the residual antimicrobial efficacy of one test
      product as defined by the difference between the number of a challenge bacterial species
      recovered following exposure to the test product and the number recovered when untreated
      (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC
      #6538) (S. aureus). Testing will be carried out using a modification of the standardized test
      method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual
      Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be
      assayed after application oftest material, using the forearms as a substrate.
At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this
      study, and will use the test product on one arm, and have the other arm untreated as the
      negative control. The test sites on both forearms will be inoculated with suspensions
      containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product
      drying time, and at approximately 2 hours and 4 hours following test material applications.
      The test sites will be sampled using the cup scrub procedure approximately 20 minutes
      following each inoculation. The log 10 microbial recoveries of treated versus untreated sites
      will be the basis for assessing the residual antimicrobial effectiveness of the test product.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Significant Log 10 Microbial Change 4 hours post application
time frame: 4 hours
arm group label: Test product
arm group type: Experimental
intervention type: Drug
intervention name: CGB-S-100
description: Alcohol and choline geranate
arm group label: Test product
other name: IonLAST gel (CGB-S-100 gel)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Senior Scientist
role: Principal Investigator
affiliation: BIOSCIENCE LAB ORA TORIES, INC.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No