<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/NCT02198963</url>
  </required_header>
  <id_info>
    <org_study_id>CP01-117838</org_study_id>
    <secondary_id>130932-304.01</secondary_id>
    <nct_id>NCT02198963</nct_id>
  </id_info>
  <brief_title>21 Day Cumulative Skin Irritation of RUT058-60</brief_title>
  <official_title>Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pulmatrix Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pulmatrix Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the skin irritation potential of RUT058-60 after&#xD;
      repetitive patch application to abraded and non-abraded skin of human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Cumulative Irritation Evaluation is designed to determine the skin irritation potential&#xD;
      of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy&#xD;
      human subjects. Abraded skin will be challenged because the Test Product may be used, in&#xD;
      practice, on non-intact skin. The primary research objective in this study is determine the&#xD;
      skin irritation potential of RUT058-60. This question will be answered based on the observed&#xD;
      results acquired evaluating its application to the abraded and non-abraded skin of at least&#xD;
      30 volunteer subjects, on the test product relative to the control readings.&#xD;
&#xD;
      A sufficient number of subjects will be recruited into the study to ensure 30 subjects,&#xD;
      including both males and females, complete the study. Prior to the first application of test&#xD;
      materials, designated skin sites will be abraded using the Tape Stripping Procedure.&#xD;
      Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive&#xD;
      Control and Negative Control to abraded and non-abraded sites on the skin in the scapular&#xD;
      region of each subject's back. The irritation potential of the test materials will be&#xD;
      determined over the course of a 21-day challenge period on at least 30 subjects. A test&#xD;
      material will be applied to the same site, abraded and non-abraded, on each day for 21 days.&#xD;
      The six skin sites will be evaluated visually prior to each patch application and following&#xD;
      the final patch removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 1</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin</measure>
    <time_frame>21 days</time_frame>
    <description>Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.&#xD;
Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Irritation/Irritant</condition>
  <arm_group>
    <arm_group_label>Hypochlorous acid Solution 106 mg/L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Occlusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.1% (w/v) Sodium Lauryl Sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Occlusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.9% Physiological Saline, USP</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Occlusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hypochlorous acid solution 106 mg/L</intervention_name>
    <description>test product</description>
    <arm_group_label>Hypochlorous acid Solution 106 mg/L</arm_group_label>
    <other_name>RUT058-60</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.1% (w/v) Sodium Lauryl Sulfate</intervention_name>
    <description>positive control</description>
    <arm_group_label>0.1% (w/v) Sodium Lauryl Sulfate</arm_group_label>
    <other_name>SLS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% Physiological Saline, USP</intervention_name>
    <description>negative control</description>
    <arm_group_label>0.9% Physiological Saline, USP</arm_group_label>
    <other_name>sterile saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects may be of either sex, at least 18 years of age and of any race&#xD;
&#xD;
          -  Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions, or other&#xD;
             disorders on the parascapular skin of the back&#xD;
&#xD;
          -  Subjects must be in good general health, as evidenced by the Subject Confidential&#xD;
             Information and Acceptance Criteria and confirmed by screening laboratory evaluations&#xD;
&#xD;
          -  Subjects must read and sign an Informed Consent Form, Subject Confidential Information&#xD;
             and Acceptance Criteria, Authorization to Use and Disclose Protected Health&#xD;
             Information Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies to latex (rubber), metals, ink, tape and/or adhesives, soap,&#xD;
             hypochlorous acid, sodium lauryl sulfate, physiological Saline&#xD;
&#xD;
          -  Exposure of the upper back region to antimicrobial agents, medicated soaps, medicated&#xD;
             shampoos, medicated lotions, or strong detergents in the 7 days prior to, or during&#xD;
             the 3-week test period; or sun-tanning, use of tanning beds, or swimming or soaking in&#xD;
             pools or hot tubs&#xD;
&#xD;
          -  Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory&#xD;
             medications in the 7 days prior to, or during the 3-week test period&#xD;
&#xD;
          -  A medical diagnosis of a physical condition, such as a current or recent severe&#xD;
             illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse,&#xD;
             congenital heart disease, internal prostheses, or any immunocompromised condition,&#xD;
             such as AIDS (or HIV positive)&#xD;
&#xD;
          -  Pregnancy, plans to become pregnant within the pre-test period or test days of the&#xD;
             study, or nursing a child. Women cannot be pregnant, as evidenced by a negative urine&#xD;
             pregnancy test, or should be of non-childbearing potential; that is, surgically&#xD;
             sterile or postmenopausal (amenorrhea for at least 12 months)&#xD;
&#xD;
          -  Any active skin rashes or breaks in the skin of the parascapular region of the back&#xD;
&#xD;
          -  Any sunburn or tattoos on the skin of the parascapular region of the back&#xD;
&#xD;
          -  A currently active skin disease or inflammatory skin condition, including contact&#xD;
             dermatitis&#xD;
&#xD;
          -  Participation in a clinical study in the past 7 days or current participation in&#xD;
             another clinical study&#xD;
&#xD;
          -  Any medical condition or use of any medications that, in the opinion of the Principal&#xD;
             Investigator, should preclude participation&#xD;
&#xD;
          -  Clinical laboratory assessments that are determined by the Principal Investigator to&#xD;
             indicate a clinically relevant abnormality and/or an exclusionary medical condition&#xD;
&#xD;
          -  Unwillingness to fulfill the performance requirements of the study&#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>John Pullman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioScience Laboratories, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioScience Laboratories, Inc.</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>February 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>August 10, 2015</results_first_submitted>
  <results_first_submitted_qc>February 2, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 4, 2016</results_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin irritation potential of RUT058-60.</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited and screened at a single US center</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>RUT058-60 vs Negative Control vs Positive Control</title>
          <description>Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RUT058-60 vs Negative and Positve Controls</title>
          <description>All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" spread="13.3"/>
                  </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="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin</title>
        <description>Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.&#xD;
Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.</description>
        <time_frame>21 days</time_frame>
        <population>Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites</population>
        <group_list>
          <group group_id="O1">
            <title>Hypochlorous Acid Solution 106 mg/L-Abraded</title>
            <description>0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.</description>
          </group>
          <group group_id="O2">
            <title>Sodium Lauryl Sulfate (0.1%) -Abraded</title>
            <description>0.02 mL of the Positive Control applied to abraded skin sites.</description>
          </group>
          <group group_id="O3">
            <title>Physiological Saline (0.9%), USP-Abraded</title>
            <description>0.02 mL of the Negative Control applied to abraded skin sites.</description>
          </group>
          <group group_id="O4">
            <title>Hypochlorous Acid Solution 106 mg/L- Non-Abraded</title>
            <description>0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.</description>
          </group>
          <group group_id="O5">
            <title>Sodium Lauryl Sulfate (0.1%)- Non-Abraded</title>
            <description>0.02 mL of the Positive Control applied to non-abraded skin sites.</description>
          </group>
          <group group_id="O6">
            <title>Physiological Saline (0.9%), USP- Non-Abraded</title>
            <description>0.02 mL of the Negative Control applied to non-abraded skin sites.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin</title>
          <description>Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.&#xD;
Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.</description>
          <population>Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="36"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.68"/>
                    <measurement group_id="O2" value="2.46" spread="0.55"/>
                    <measurement group_id="O3" value="1.34" spread="0.44"/>
                    <measurement group_id="O4" value="0.58" spread="0.33"/>
                    <measurement group_id="O5" value="1.84" spread="0.58"/>
                    <measurement group_id="O6" value="0.82" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>RUT058-60 vs Negative and Positve Controls</title>
          <description>All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.</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="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18</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="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </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>Disclosure Agreement</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Results from 36 subjects receiving all applications and completing all visits</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. John Pullman</name_or_title>
      <organization>Mercury Street Medical</organization>
      <phone>(406) 723-1375</phone>
      <email>john.pullman@mecurystmed.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/NCT02198963
org study id: CP01-117838
secondary id: 130932-304.01
nct id: NCT02198963
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the skin irritation potential of RUT058-60 after
      repetitive patch application to abraded and non-abraded skin of human subjects.
This Cumulative Irritation Evaluation is designed to determine the skin irritation potential
      of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy
      human subjects. Abraded skin will be challenged because the Test Product may be used, in
      practice, on non-intact skin. The primary research objective in this study is determine the
      skin irritation potential of RUT058-60. This question will be answered based on the observed
      results acquired evaluating its application to the abraded and non-abraded skin of at least
      30 volunteer subjects, on the test product relative to the control readings.

      A sufficient number of subjects will be recruited into the study to ensure 30 subjects,
      including both males and females, complete the study. Prior to the first application of test
      materials, designated skin sites will be abraded using the Tape Stripping Procedure.
      Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive
      Control and Negative Control to abraded and non-abraded sites on the skin in the scapular
      region of each subject's back. The irritation potential of the test materials will be
      determined over the course of a 21-day challenge period on at least 30 subjects. A test
      material will be applied to the same site, abraded and non-abraded, on each day for 21 days.
      The six skin sites will be evaluated visually prior to each patch application and following
      the final patch removal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin
time frame: 21 days
description: Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.
Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.
arm group label: Hypochlorous acid Solution 106 mg/L
arm group type: Experimental
description: Occlusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back.
arm group label: 0.1% (w/v) Sodium Lauryl Sulfate
arm group type: Active Comparator
description: Occlusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.
arm group label: 0.9% Physiological Saline, USP
arm group type: Placebo Comparator
description: Occlusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.
intervention type: Drug
intervention name: Hypochlorous acid solution 106 mg/L
description: test product
arm group label: Hypochlorous acid Solution 106 mg/L
other name: RUT058-60
intervention type: Drug
intervention name: 0.1% (w/v) Sodium Lauryl Sulfate
description: positive control
arm group label: 0.1% (w/v) Sodium Lauryl Sulfate
other name: SLS
intervention type: Drug
intervention name: 0.9% Physiological Saline, USP
description: negative control
arm group label: 0.9% Physiological Saline, USP
other name: sterile saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John Pullman, M.D.
role: Principal Investigator
affiliation: BioScience Laboratories, Inc.
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Results from 36 subjects receiving all applications and completing all visits
point of contact: 