<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/NCT04498676</url>
  </required_header>
  <id_info>
    <org_study_id>MS17.RIPT.P1200O.50.CBIO</org_study_id>
    <nct_id>NCT04498676</nct_id>
  </id_info>
  <brief_title>50 Human Subject Repeat Insult Patch Test</brief_title>
  <acronym>HRIPT</acronym>
  <official_title>50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CAGE Bio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AMA Laboratories Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CAGE Bio 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>
      Consumer products or raw materials designed for consistent reapplication to areas of the skin&#xD;
      may, under proper conditions, prove to be contact sensitizers or irritants in certain&#xD;
      individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for&#xD;
      evaluation of this irritation/sensitization potential if such exists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">March 2, 2017</completion_date>
  <primary_completion_date type="Actual">February 8, 2017</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Erythema</measure>
    <time_frame>21 days</time_frame>
    <description>Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitisation</measure>
    <time_frame>24 hours</time_frame>
    <description>After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitisation</measure>
    <time_frame>48 hours</time_frame>
    <description>After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Erythema</condition>
  <condition>Sensitisation</condition>
  <arm_group>
    <arm_group_label>Test product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CB-0002B</intervention_name>
    <description>CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid</description>
    <arm_group_label>Test product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who are not currently under a doctor's care&#xD;
&#xD;
          -  Individuals free of any dermatological or systemic disorder which would interfere with&#xD;
             the results, at the discretion of the Investigator.&#xD;
&#xD;
          -  Individuals free of any acute or chronic disease that might interfere with or increase&#xD;
             the risk of study participation.&#xD;
&#xD;
          -  Individuals who will complete a preliminary medical history form mandated by AMA&#xD;
             Laboratories, Inc. and are in general good health.&#xD;
&#xD;
          -  Individuals, who will read, understand and sign an informed consent document relating&#xD;
             to the specific type of study they are subscribing. Consent forms are kept on file and&#xD;
             are available for examination on the premises of AMA Laboratories, Inc. only.&#xD;
&#xD;
          -  Individuals able to cooperate with the Investigator and research staff, willing to&#xD;
             have test materials applied according to the protocol, and complete the full course of&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals under 18 years of age.&#xD;
&#xD;
          -  Individuals who are currently under a doctor's care.&#xD;
&#xD;
          -  Individuals who are currently taking any medication (topical or systemic) that may&#xD;
             mask or interfere with the test results.&#xD;
&#xD;
          -  Subjects with a history of any acute or chronic disease that might interfere with or&#xD;
             increase the risk associated with study participation.&#xD;
&#xD;
          -  Individuals diagnosed with chronic skin allergies.&#xD;
&#xD;
          -  Female volunteers who indicate that they are pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Director</last_name>
    <role>Study Director</role>
    <affiliation>AMA Laboratories Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AMA Laboratories Inc.</name>
      <address>
        <city>New City</city>
        <state>New York</state>
        <zip>10956</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HRIPT</keyword>
  <keyword>irritant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythema</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/NCT04498676
org study id: MS17.RIPT.P1200O.50.CBIO
nct id: NCT04498676
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Consumer products or raw materials designed for consistent reapplication to areas of the skin
      may, under proper conditions, prove to be contact sensitizers or irritants in certain
      individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for
      evaluation of this irritation/sensitization potential if such exists.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Erythema
time frame: 21 days
description: Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
measure: Sensitisation
time frame: 24 hours
description: After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
measure: Sensitisation
time frame: 48 hours
description: After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
arm group label: Test product
arm group type: Experimental
intervention type: Other
intervention name: CB-0002B
description: CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid
arm group label: Test product
criteria: 
gender: All
minimum age: 21 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Director
role: Study Director
affiliation: AMA Laboratories Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Erythema
sharing ipd: No