<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/NCT03233009</url>
  </required_header>
  <id_info>
    <org_study_id>207235</org_study_id>
    <nct_id>NCT03233009</nct_id>
  </id_info>
  <brief_title>To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test</brief_title>
  <official_title>A Human Subject 24 Hour Patch Test to Assess the Irritation Potential of Four Skin Serum Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</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>
      To assess the irritation potential of four prototype daily defense serum formulations after&#xD;
      24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an evaluator (single) blind, test site randomized and intra-subject comparison patch&#xD;
      test study to evaluate the cutaneous irritation potential of four experimental daily defense&#xD;
      serum formulations, including a saline solution as a negative control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">May 26, 2017</completion_date>
  <primary_completion_date type="Actual">May 26, 2017</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal</measure>
    <time_frame>At Day 2 (15-30 minutes post patch removal)</time_frame>
    <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Dermal Response Score at 24 Hours Post Patch Removal</measure>
    <time_frame>At Day 3 (24 hours post patch removal)</time_frame>
    <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Dermal Response Score at 48 Hours Post Patch Removal</measure>
    <time_frame>At Day 4 (48 hours post patch removal)</time_frame>
    <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dermal Response Score at 30 Minutes Post Patch Removal</measure>
    <time_frame>At Day 2 (15-30 minutes post patch removal)</time_frame>
    <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dermal Response Score at 24 Hours Post Patch Removal</measure>
    <time_frame>At Day 3 (24 hours post patch removal)</time_frame>
    <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dermal Response Score at 48 Hours Post Patch Removal</measure>
    <time_frame>At Day 4 (48 hours post patch removal)</time_frame>
    <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal</measure>
    <time_frame>At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal</time_frame>
    <description>A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or 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.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score &gt;0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Skin Care</condition>
  <arm_group>
    <arm_group_label>Test Product 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will topically apply test product 1 via semi occlusive patch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will topically apply test product 2 via semi occlusive patch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will topically apply test product 3 via semi occlusive patch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will topically apply test product 4 via semi occlusive patch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Product</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will topically apply Reference product via semi occlusive patch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Daily Defense Serum A</intervention_name>
    <description>Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).</description>
    <arm_group_label>Test Product 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Daily Defense Serum C</intervention_name>
    <description>Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).</description>
    <arm_group_label>Test Product 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Daily Defense Serum G</intervention_name>
    <description>Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).</description>
    <arm_group_label>Test Product 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Daily Defense Serum N</intervention_name>
    <description>Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).</description>
    <arm_group_label>Test Product 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline Solution Sodium Chloride</intervention_name>
    <description>Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).</description>
    <arm_group_label>Reference Product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study procedures, restrictions and willingness to&#xD;
             participate as evidenced by voluntary written informed consent and has received a&#xD;
             signed and dated copy of the informed consent form.&#xD;
&#xD;
          -  General health: Good general and mental health with, in the opinion of the&#xD;
             investigator or medically qualified designee no clinically significant and relevant&#xD;
             abnormalities in medical history or upon physical examination and participants must&#xD;
             have intact skin on the proposed application site; dorsum (scapular region).&#xD;
&#xD;
          -  Fitzpatrick photo type I to IV.&#xD;
&#xD;
          -  Agreement to comply with the procedures and requirements of the study and to attend&#xD;
             the scheduled assessment visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are known to be pregnant or who are intending to become pregnant over the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Women who are breast-feeding.&#xD;
&#xD;
          -  Any history of significant dermatological diseases or conditions or medical conditions&#xD;
             known to alter skin appearance or physiologic response (e.g. diabetes,) which could,&#xD;
             in the opinion of the Investigator, preclude topical application of the&#xD;
             investigational products and/or interfere with the evaluation of the test site&#xD;
             reaction.&#xD;
&#xD;
          -  Presence of open sores, pimples, or cysts at the application site.&#xD;
&#xD;
          -  Active dermatosis (local or disseminated) that might interfere with the results of the&#xD;
             study&#xD;
&#xD;
          -  Considered immune compromised.&#xD;
&#xD;
          -  History of diseases aggravated or triggered by ultraviolet radiation.&#xD;
&#xD;
          -  Participants with dermatographism.&#xD;
&#xD;
          -  Currently using any medication which in the opinion of the investigator, may affect&#xD;
             the evaluation of the study product, or place the participant at undue risk.&#xD;
&#xD;
          -  Use of the following topical or systemic medications: immunosuppressants,&#xD;
             antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2&#xD;
             weeks before Screening visit.&#xD;
&#xD;
          -  Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month&#xD;
             before the screening visit.&#xD;
&#xD;
          -  Intention of being vaccinated during the study period or vaccination within 3 weeks of&#xD;
             the Screening visit.&#xD;
&#xD;
          -  Currently receiving allergy injections, or due to receive an injection within 7 days&#xD;
             prior to Visit 1, or expects to begin injections during study participation.&#xD;
&#xD;
          -  Previous history of atopy, allergic reactions, irritation or intense discomfort&#xD;
             feelings to topical-use products, cosmetics or medication.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to any of the study materials (or&#xD;
             closely related compounds) or any of their stated ingredients, including any component&#xD;
             of the patches.&#xD;
&#xD;
          -  History of sensitization in a previous patch study.&#xD;
&#xD;
          -  Participation in another clinical study (including cosmetic studies) or receipt of an&#xD;
             investigational drug within 30 days of the Screening visit.&#xD;
&#xD;
          -  Previous participation in this study.&#xD;
&#xD;
          -  Recent history (within the last 5 years) of alcohol or other substance abuse.&#xD;
&#xD;
          -  Intense sunlight exposure or sun tanning sessions up to 30 days before the Screening&#xD;
             evaluation Intention of bathing, sauna, water sports, or activities that lead to&#xD;
             intense sweating.&#xD;
&#xD;
          -  Any participant who, in the judgment of the Investigator, should not participate in&#xD;
             the study.&#xD;
&#xD;
          -  Any skin marks on the test site that might interfere with the evaluation of possible&#xD;
             skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos,&#xD;
             excessive hair, numerous freckles).&#xD;
&#xD;
          -  Prisoner or involuntary incarcerated participant.&#xD;
&#xD;
          -  Participant from an indigenous tribe.&#xD;
&#xD;
          -  An employee of the sponsor or the study site or members of their immediate family.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valinhos</city>
        <zip>13271-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valinhos</city>
        <zip>13271-</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&amp;amp;parentIdentifier=207235&amp;amp;attachmentIdentifier=86ec8b21-ef92-4a57-9623-7afe670832a7&amp;amp;fileName=gsk-207235-clinical-study-report-redact.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>April 20, 2018</results_first_submitted>
  <results_first_submitted_qc>September 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2018</results_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03233009/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03233009/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All the participants were enrolled at one center in Brazil.</recruitment_details>
      <pre_assignment_details>A total of 46 participants were screened, out of which 3 participants did not meet study criteria, 43 participants were enrolled in the study out of which 3 participants withdrew their consent. Remaining 40 participants were randomized to the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Participants</title>
          <description>All participants enrolled in the study received all the study products. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch in a randomized manner. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Test Product 1</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Test Product 2</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Test Product 3</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Test Product 4</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Reference Product</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline population reflects the safety population. The safety population (N= 40) included all participants who received any of the test products</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Participants</title>
          <description>All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.7" spread="11.65"/>
                  </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="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal</title>
        <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 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.</description>
        <time_frame>At Day 2 (15-30 minutes post patch removal)</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal</title>
          <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 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.</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Dermal Response Score at 24 Hours Post Patch Removal</title>
        <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 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.</description>
        <time_frame>At Day 3 (24 hours post patch removal)</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Dermal Response Score at 24 Hours Post Patch Removal</title>
          <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 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.</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Dermal Response Score at 48 Hours Post Patch Removal</title>
        <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.</description>
        <time_frame>At Day 4 (48 hours post patch removal)</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Dermal Response Score at 48 Hours Post Patch Removal</title>
          <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dermal Response Score at 30 Minutes Post Patch Removal</title>
        <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 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.</description>
        <time_frame>At Day 2 (15-30 minutes post patch removal)</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dermal Response Score at 30 Minutes Post Patch Removal</title>
          <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 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.</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Score on 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="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dermal Response Score at 24 Hours Post Patch Removal</title>
        <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 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.</description>
        <time_frame>At Day 3 (24 hours post patch removal)</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dermal Response Score at 24 Hours Post Patch Removal</title>
          <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 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.</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Score on 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="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dermal Response Score at 48 Hours Post Patch Removal</title>
        <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.</description>
        <time_frame>At Day 4 (48 hours post patch removal)</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dermal Response Score at 48 Hours Post Patch Removal</title>
          <description>Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Score on 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="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal</title>
        <description>A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or 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.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score &gt;0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily</description>
        <time_frame>At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal</time_frame>
        <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product 1</title>
            <description>This arm includes data from the test sites where test product 1 was applied.</description>
          </group>
          <group group_id="O2">
            <title>Test Product 2</title>
            <description>This arm includes data from the test sites where test product 2 was applied.</description>
          </group>
          <group group_id="O3">
            <title>Test Product 3</title>
            <description>This arm includes data from the test sites where test product 3 was applied.</description>
          </group>
          <group group_id="O4">
            <title>Test Product 4</title>
            <description>This arm includes data from the test sites where test product 4 was applied.</description>
          </group>
          <group group_id="O5">
            <title>Reference Product</title>
            <description>This arm includes data from the test sites where reference product was applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal</title>
          <description>A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or 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.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score &gt;0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily</description>
          <population>The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="39"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2 (15-30 minutes)</title>
              <category_list>
                <category>
                  <title>No effect</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade A/Score 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade B/Score 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade C/Score 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade F/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade G/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade H/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 (24 hours)</title>
              <category_list>
                <category>
                  <title>No effect</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade A/Score 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade B/Score 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade C/Score 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade F/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade G/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade H/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (48 hours)</title>
              <category_list>
                <category>
                  <title>No effect</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade A/Score 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade B/Score 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade C/Score 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade F/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade G/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade H/Score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 4 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Product 1</title>
          <description>This arm includes data from the test sites where test product 1 was applied.</description>
        </group>
        <group group_id="E2">
          <title>Test Product 2</title>
          <description>This arm includes data from the test sites where test product 2 was applied.</description>
        </group>
        <group group_id="E3">
          <title>Test Product 3</title>
          <description>This arm includes data from the test sites where test product 3 was applied.</description>
        </group>
        <group group_id="E4">
          <title>Test Product 4</title>
          <description>This arm includes data from the test sites where test product 4 was applied.</description>
        </group>
        <group group_id="E5">
          <title>Reference Product</title>
          <description>This arm includes data from the test sites where reference product was applied.</description>
        </group>
        <group group_id="E6">
          <title>Overall Participants</title>
          <description>All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.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/NCT03233009
org study id: 207235
nct id: NCT03233009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the irritation potential of four prototype daily defense serum formulations after
      24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.
This is an evaluator (single) blind, test site randomized and intra-subject comparison patch
      test study to evaluate the cutaneous irritation potential of four experimental daily defense
      serum formulations, including a saline solution as a negative control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal
time frame: At Day 2 (15-30 minutes post patch removal)
description: Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 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.
measure: Frequency of Dermal Response Score at 24 Hours Post Patch Removal
time frame: At Day 3 (24 hours post patch removal)
description: Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 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.
measure: Frequency of Dermal Response Score at 48 Hours Post Patch Removal
time frame: At Day 4 (48 hours post patch removal)
description: Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.
measure: Average Dermal Response Score at 30 Minutes Post Patch Removal
time frame: At Day 2 (15-30 minutes post patch removal)
description: Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 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.
measure: Average Dermal Response Score at 24 Hours Post Patch Removal
time frame: At Day 3 (24 hours post patch removal)
description: Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 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.
measure: Average Dermal Response Score at 48 Hours Post Patch Removal
time frame: At Day 4 (48 hours post patch removal)
description: Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 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.
measure: Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal
time frame: At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal
description: A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or 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.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score >0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily
arm group label: Test Product 1
arm group type: Experimental
description: Participants will topically apply test product 1 via semi occlusive patch.
arm group label: Test Product 2
arm group type: Experimental
description: Participants will topically apply test product 2 via semi occlusive patch.
arm group label: Test Product 3
arm group type: Experimental
description: Participants will topically apply test product 3 via semi occlusive patch.
arm group label: Test Product 4
arm group type: Experimental
description: Participants will topically apply test product 4 via semi occlusive patch.
arm group label: Reference Product
arm group type: Sham Comparator
description: Participants will topically apply Reference product via semi occlusive patch.
intervention type: Other
intervention name: Experimental Daily Defense Serum A
description: Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
arm group label: Test Product 1
intervention type: Other
intervention name: Experimental Daily Defense Serum C
description: Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
arm group label: Test Product 2
intervention type: Other
intervention name: Experimental Daily Defense Serum G
description: Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
arm group label: Test Product 3
intervention type: Other
intervention name: Experimental Daily Defense Serum N
description: Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
arm group label: Test Product 4
intervention type: Other
intervention name: Saline Solution Sodium Chloride
description: Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
arm group label: Reference Product
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
facility: 
facility: 
country: Brazil
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&amp;parentIdentifier=207235&amp;attachmentIdentifier=86ec8b21-ef92-4a57-9623-7afe670832a7&amp;fileName=gsk-207235-clinical-study-report-redact.pdf&amp;versionIdentifier=
description: Related Info
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 