<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/NCT02224625</url>
  </required_header>
  <id_info>
    <org_study_id>R13-051</org_study_id>
    <nct_id>NCT02224625</nct_id>
  </id_info>
  <brief_title>Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth</brief_title>
  <official_title>Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medline Industries</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medline Industries</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product&#xD;
      applied to see if they become sensitized to repeated applications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG&#xD;
      comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin&#xD;
      irritation) will be placed on the same spot of your skin every day for 21 days. The skin will&#xD;
      be examined every day.&#xD;
&#xD;
      The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline,&#xD;
      CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the&#xD;
      patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Grading Scale for Visual Evaluation of Skin Condition</measure>
    <time_frame>21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)</time_frame>
    <description>Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.&#xD;
Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.&#xD;
Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">249</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>2% CHG Cloth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chlorhexidine Gluconate 2%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Cloth</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Excipients on cloth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DynaHex (2% CHG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chlorhexidine Gluconate 2% solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>0.9% sodium chloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium Lauryl Sulfate (SLS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sodium lauryl sulfate to produce mild irritation as a positive control</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% CHG Cloth solution</intervention_name>
    <description>Investigational CHG</description>
    <arm_group_label>2% CHG Cloth</arm_group_label>
    <other_name>Chlorhexidine Gluconate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vehicle Cloth</intervention_name>
    <description>Excipients from CHG cloth only</description>
    <arm_group_label>Vehicle Cloth</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Comparator</intervention_name>
    <description>Active comparator</description>
    <arm_group_label>DynaHex (2% CHG)</arm_group_label>
    <other_name>DynaHex-2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Negative control</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SLS</intervention_name>
    <description>Provides a slight irritation for a positive control</description>
    <arm_group_label>Sodium Lauryl Sulfate (SLS)</arm_group_label>
    <other_name>Sodium Lauryl Sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Free of skin disorders&#xD;
&#xD;
          -  Signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to latex&#xD;
&#xD;
          -  Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or&#xD;
             during testing&#xD;
&#xD;
          -  severe illness&#xD;
&#xD;
          -  Pregnant (females)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J Pullman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioScience Laboratories</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioScience Laboratories</name>
      <address>
        <city>Butte</city>
        <state>Montana</state>
        <zip>59701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>February 5, 2016</results_first_submitted>
  <results_first_submitted_qc>April 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 2016</results_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data to be shared with FDA</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>39 of the 249 participants participated in both the Irritation and Sensitization Studies.</recruitment_details>
      <pre_assignment_details>Participants received up to 5 products simultaneously on their skin. SLS was only used in the Irritation study (39 subjects) as a positive control.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>2% CHG Cloth, Vehicle, DynaHex, Saline, SLS</title>
          <description>Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Irritation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Sensitization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="249">Subjects from Irritation study also participated in Sensitization Study</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="194"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants in the Sensitization study received the following 4 products ( 2% CHG cloth, Vehicle cloth, DynaHex and Saline). Participants in the Irritation study received the same 4 products in addition to SLS.</population>
      <group_list>
        <group group_id="B1">
          <title>2% CHG, Vehicle, DynaHex, Saline</title>
          <description>Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="249"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38" lower_limit="16" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Grading Scale for Visual Evaluation of Skin Condition</title>
        <description>Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.&#xD;
Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.&#xD;
Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading</description>
        <time_frame>21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)</time_frame>
        <population>Participants received more than one product at a time.</population>
        <group_list>
          <group group_id="O1">
            <title>2% CHG Cloth</title>
            <description>Chlorhexidine Gluconate 2%&#xD;
2% CHG Cloth: CHG solution on cloth</description>
          </group>
          <group group_id="O2">
            <title>Vehicle Cloth</title>
            <description>Excipients on cloth&#xD;
Vehicle Cloth: Excipients from CHG cloth only</description>
          </group>
          <group group_id="O3">
            <title>DynaHex (2% CHG)</title>
            <description>Chlorhexidine Gluconate 2% solution&#xD;
Active Comparator: 2% CHG solution</description>
          </group>
          <group group_id="O4">
            <title>Saline</title>
            <description>0.9% sodium chloride&#xD;
Saline: Negative control</description>
          </group>
          <group group_id="O5">
            <title>Sodium Lauryl Sulfate (SLS)</title>
            <description>Sodium lauryl sulfate to produce mild irritation as a positive control&#xD;
SLS: Provides a slight irritation for a positive control</description>
          </group>
        </group_list>
        <measure>
          <title>Grading Scale for Visual Evaluation of Skin Condition</title>
          <description>Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.&#xD;
Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.&#xD;
Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading</description>
          <population>Participants received more than one product at a time.</population>
          <units>Scores Ranging (0-7)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="249"/>
                <count group_id="O2" value="249"/>
                <count group_id="O3" value="249"/>
                <count group_id="O4" value="249"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Irritation Mean Visualization Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritation Mean Visualization Score Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O3" value="3.3" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="O4" value="0.7" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O5" value="3.0" lower_limit="3" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitization Mean Visualization Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitization Mean Visualization Score Day 35</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.03" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O3" value="0.03" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events reported over a 21 (irritation) and 35 (sensitization) day period.</time_frame>
      <desc>Participants received up to 5 different products simultaneously during the study. Adverse skin reactions with known relationships to the products applied were reported individually. Non-skin related adverse events were also captured during the study but could not be associated directly with a particular treatment and are not included.</desc>
      <group_list>
        <group group_id="E1">
          <title>2% CHG Cloth</title>
          <description>Chlorhexidine Gluconate 2%&#xD;
2% CHG Cloth: CHG solution on cloth</description>
        </group>
        <group group_id="E2">
          <title>Vehicle Cloth</title>
          <description>Excipients on cloth&#xD;
Vehicle Cloth: Excipients from CHG cloth only</description>
        </group>
        <group group_id="E3">
          <title>DynaHex (2% CHG)</title>
          <description>Chlorhexidine Gluconate 2% solution&#xD;
Active Comparator: 2% CHG solution</description>
        </group>
        <group group_id="E4">
          <title>Saline</title>
          <description>0.9% sodium chloride&#xD;
Saline: Negative control</description>
        </group>
        <group group_id="E5">
          <title>Sodium Lauryl Sulfate (SLS)</title>
          <description>Sodium lauryl sulfate to produce mild irritation as a positive control&#xD;
SLS: Provides a slight irritation for a positive control</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="249"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="249"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="249"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Irritation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="249"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Confidential information based on contract</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>C Beausoleil</name_or_title>
      <organization>Bioscience Labs</organization>
      <phone>406-587-5735</phone>
      <email>cbeausoleil@bioscience.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02224625
org study id: R13-051
nct id: NCT02224625
lead sponsor: 
has dmc: No
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product
      applied to see if they become sensitized to repeated applications.
For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG
      comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin
      irritation) will be placed on the same spot of your skin every day for 21 days. The skin will
      be examined every day.

      The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline,
      CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the
      patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Grading Scale for Visual Evaluation of Skin Condition
time frame: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
description: Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.
Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.
Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading
arm group label: 2% CHG Cloth
arm group type: Experimental
description: Chlorhexidine Gluconate 2%
arm group label: Vehicle Cloth
arm group type: Placebo Comparator
description: Excipients on cloth
arm group label: DynaHex (2% CHG)
arm group type: Active Comparator
description: Chlorhexidine Gluconate 2% solution
arm group label: Saline
arm group type: Sham Comparator
description: 0.9% sodium chloride
arm group label: Sodium Lauryl Sulfate (SLS)
arm group type: Active Comparator
description: Sodium lauryl sulfate to produce mild irritation as a positive control
intervention type: Drug
intervention name: 2% CHG Cloth solution
description: Investigational CHG
arm group label: 2% CHG Cloth
other name: Chlorhexidine Gluconate
intervention type: Device
intervention name: Vehicle Cloth
description: Excipients from CHG cloth only
arm group label: Vehicle Cloth
other name: Control
intervention type: Drug
intervention name: Active Comparator
description: Active comparator
arm group label: DynaHex (2% CHG)
other name: DynaHex-2
intervention type: Other
intervention name: Saline
description: Negative control
arm group label: Saline
intervention type: Other
intervention name: SLS
description: Provides a slight irritation for a positive control
arm group label: Sodium Lauryl Sulfate (SLS)
other name: Sodium Lauryl Sulfate
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: J Pullman, MD
role: Principal Investigator
affiliation: BioScience Laboratories
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
sharing ipd: Yes
ipd description: Data to be shared with FDA
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 