<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/NCT02995057</url>
  </required_header>
  <id_info>
    <org_study_id>H14-02324</org_study_id>
    <nct_id>NCT02995057</nct_id>
  </id_info>
  <brief_title>Safety Demonstration of Microneedle Insertion</brief_title>
  <official_title>Safety Demonstration of Microneedle Insertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of&#xD;
      humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety&#xD;
      in patients. An alternative drug and vaccine delivery method is the use of hollow&#xD;
      microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and&#xD;
      bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a&#xD;
      result, they are better received by patients and do not induce needle anxiety. As the&#xD;
      investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel,&#xD;
      the purpose of this study is to observe their biocompatibility and inertness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skin reaction as measured by a contact dermatitis classification system</measure>
    <time_frame>7 days</time_frame>
    <description>Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Allergic Reaction to Nickel</condition>
  <arm_group>
    <arm_group_label>Nickel allergic</arm_group_label>
    <description>Participants have proven nickel allergy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gold- or silver-coated, or uncoated nickel microneedles</intervention_name>
    <description>The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.</description>
    <arm_group_label>Nickel allergic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        15 subjects will be enrolled in the trial. Subjects who meet all of the inclusion criteria&#xD;
        and none of the exclusion criteria will be eligible to enroll in the trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Proven nickel allergy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urs Hafeli, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 26, 2015</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microneedles</keyword>
  <keyword>Biocompatibility</keyword>
  <keyword>Allergy</keyword>
  <keyword>Metal</keyword>
  <keyword>Nickel</keyword>
  <keyword>Contact dermatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nickel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995057
org study id: H14-02324
nct id: NCT02995057
lead sponsor: 
collaborator: 
has dmc: No
Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of
      humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety
      in patients. An alternative drug and vaccine delivery method is the use of hollow
      microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and
      bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a
      result, they are better received by patients and do not induce needle anxiety. As the
      investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel,
      the purpose of this study is to observe their biocompatibility and inertness.
time perspective: Prospective
measure: Skin reaction as measured by a contact dermatitis classification system
time frame: 7 days
description: Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.
arm group label: Nickel allergic
description: Participants have proven nickel allergy
intervention type: Device
intervention name: Gold- or silver-coated, or uncoated nickel microneedles
description: The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.
arm group label: Nickel allergic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Urs Hafeli, Ph.D.
role: Principal Investigator
affiliation: Professor
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Nickel
sharing ipd: No