<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/NCT04402476</url>
  </required_header>
  <id_info>
    <org_study_id>HMR-MDT-02-19-19-PT.MT</org_study_id>
    <nct_id>NCT04402476</nct_id>
  </id_info>
  <brief_title>Skin Sensitisation (Modified Draize-95 Test)</brief_title>
  <acronym>MDT-95</acronym>
  <official_title>Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PT. Medisafe Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PT. Medisafe Technologies</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for&#xD;
      a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical&#xD;
      additives at a level on the gloves that may induce type IV allergy to the unsensitized&#xD;
      general user population when using polychloroprene based surgical gloves&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To evaluate whether residual chemical additives at a level that may induce Type IV&#xD;
           allergy in the unsensitized general user population are present in a finished&#xD;
           Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical&#xD;
           Gloves, Sterile. (CR-SG-140-AF-WH)&#xD;
&#xD;
        2. To meet requirements for claim: This product demonstrated reduced potential for&#xD;
           sensitizing users to chemical additives as described in Guidance for Industry and FDA&#xD;
           Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin&#xD;
           sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human&#xD;
           subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2019</start_date>
  <completion_date type="Actual">April 6, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Induction Phase</measure>
    <time_frame>24 days</time_frame>
    <description>Irritation scored by Erythemal Scoring Scale,&#xD;
Basic Score - Description:&#xD;
0 - No visible reaction.&#xD;
0.5 - Doubtful or Negligible Erythema Reaction.&#xD;
1.0 - Mild or just perceptible macular erythema reaction in a speckled / follicular, patchy or confluent pattern (slight pinking).&#xD;
2.0 - Moderate erythema reaction in a confluent pattern (definite redness).&#xD;
3.0 - Strong or brisk erythema reaction that may spread beyond the test site.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Challenge Phase</measure>
    <time_frame>48 hours</time_frame>
    <description>Irritation scored by Erythemal Scoring Scale,&#xD;
Basic Score - Description :&#xD;
0 - No visible reaction.&#xD;
0.5 - Doubtful or Negligible Erythema Reaction.&#xD;
1.0 - Mild or just perceptible macular erythema reaction in a speckled / follicular, patchy or confluent pattern (slight pinking).&#xD;
2.0 - Moderate erythema reaction in a confluent pattern (definite redness).&#xD;
3.0 - Strong or brisk erythema reaction that may spread beyond the test site.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Skin Sensitisation</condition>
  <arm_group>
    <arm_group_label>Device and Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:&#xD;
Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, Tested for use with Chemotherapy Drugs.&#xD;
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.&#xD;
Positive Control:&#xD;
0.4% Sodium Lauryl Sulfate (SLS) Dose. 0.2 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.</intervention_name>
    <description>Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.</description>
    <arm_group_label>Device and Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The test subjects are normal volunteers who have documented informed consent and have&#xD;
             not participated in other voluntary testing for at least 30 days.&#xD;
&#xD;
          -  Age of the test subjects ranged from 18 to 65 years.&#xD;
&#xD;
          -  Efforts are made to provide racial and gender diversity of the test subjects that&#xD;
             reasonably reflects the general user population in the US&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The test subjects with any visible skin disease that might be confused with skin&#xD;
             reactions caused by the test material.&#xD;
&#xD;
          -  The test subjects with any indication of existing Type I allergy to natural rubber&#xD;
             proteins.&#xD;
&#xD;
          -  The test subjects who have used corticosteroids, either systemically or topically on&#xD;
             the potential test site, two weeks before testing.&#xD;
&#xD;
          -  Test subjects who have received endogenous or exogenous immunosuppressive treatments&#xD;
             (or prolonged sun exposure).&#xD;
&#xD;
          -  All subjects who are pregnant or become pregnant during the study.&#xD;
&#xD;
          -  All lactating women,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>104 female (50%) and 104 male (50%)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED</last_name>
    <role>Study Director</role>
    <affiliation>Makmal Bioserasi &amp; Klinikal, Healthmedic Research Sdn. Bhd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makmal Bioserasi &amp; Klinikal, Healthmedic Research Sdn. Bhd.</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Cheras</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <link>
    <url>http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm428191.pdf</url>
    <description>Medical Glove Guidance Manual</description>
  </link>
  <link>
    <url>https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-notification-510k-submissions-testing-skin-sensitization-chemicals-natural-rubber-products</url>
    <description>Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products.</description>
  </link>
  <results_reference>
    <citation>Foy V, Weinkauf R, Whittle E, Basketter DA. Ethnic variation in the skin irritation response. Contact Dermatitis. 2001 Dec;45(6):346-9. doi: 10.1034/j.1600-0536.2001.450605.x.</citation>
    <PMID>11846750</PMID>
  </results_reference>
  <results_reference>
    <citation>Kompaore F, Tsuruta H. In vivo differences between Asian, black and white in the stratum corneum barrier function. Int Arch Occup Environ Health. 1993;65(1 Suppl):S223-5. doi: 10.1007/BF00381346.</citation>
    <PMID>8406931</PMID>
  </results_reference>
  <results_reference>
    <citation>Robinson MK. Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons. Contact Dermatitis. 2002 Feb;46(2):86-93. doi: 10.1034/j.1600-0536.2002.460205.x.</citation>
    <PMID>11918601</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402476
org study id: HMR-MDT-02-19-19-PT.MT
nct id: NCT04402476
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for
      a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical
      additives at a level on the gloves that may induce type IV allergy to the unsensitized
      general user population when using polychloroprene based surgical gloves
1. To evaluate whether residual chemical additives at a level that may induce Type IV
           allergy in the unsensitized general user population are present in a finished
           Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical
           Gloves, Sterile. (CR-SG-140-AF-WH)

        2. To meet requirements for claim: This product demonstrated reduced potential for
           sensitizing users to chemical additives as described in Guidance for Industry and FDA
           Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin
           sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human
           subjects.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs
primary purpose: Treatment
masking: None (Open Label)
measure: Induction Phase
time frame: 24 days
description: Irritation scored by Erythemal Scoring Scale,
Basic Score - Description:
0 - No visible reaction.
0.5 - Doubtful or Negligible Erythema Reaction.
1.0 - Mild or just perceptible macular erythema reaction in a speckled / follicular, patchy or confluent pattern (slight pinking).
2.0 - Moderate erythema reaction in a confluent pattern (definite redness).
3.0 - Strong or brisk erythema reaction that may spread beyond the test site.
measure: Challenge Phase
time frame: 48 hours
description: Irritation scored by Erythemal Scoring Scale,
Basic Score - Description :
0 - No visible reaction.
0.5 - Doubtful or Negligible Erythema Reaction.
1.0 - Mild or just perceptible macular erythema reaction in a speckled / follicular, patchy or confluent pattern (slight pinking).
2.0 - Moderate erythema reaction in a confluent pattern (definite redness).
3.0 - Strong or brisk erythema reaction that may spread beyond the test site.
arm group label: Device and Control
arm group type: Experimental
description: Device:
Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, Tested for use with Chemotherapy Drugs.
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Positive Control:
0.4% Sodium Lauryl Sulfate (SLS) Dose. 0.2 ml
intervention type: Device
intervention name: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.
description: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
arm group label: Device and Control
criteria: 
gender: All
gender based: Yes
gender description: 104 female (50%) and 104 male (50%)
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED
role: Study Director
affiliation: Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
facility: 
country: Malaysia
url: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm428191.pdf
description: Medical Glove Guidance Manual
url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-notification-510k-submissions-testing-skin-sensitization-chemicals-natural-rubber-products
description: Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products.
citation: Foy V, Weinkauf R, Whittle E, Basketter DA. Ethnic variation in the skin irritation response. Contact Dermatitis. 2001 Dec;45(6):346-9. doi: 10.1034/j.1600-0536.2001.450605.x.
PMID: 11846750
citation: Kompaore F, Tsuruta H. In vivo differences between Asian, black and white in the stratum corneum barrier function. Int Arch Occup Environ Health. 1993;65(1 Suppl):S223-5. doi: 10.1007/BF00381346.
PMID: 8406931
citation: Robinson MK. Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons. Contact Dermatitis. 2002 Feb;46(2):86-93. doi: 10.1034/j.1600-0536.2002.460205.x.
PMID: 11918601
responsible party type: Sponsor
sharing ipd: No