xml: <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/NCT06034340</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002928</org_study_id>
      <nct_id>NCT06034340</nct_id>
    </id_info>
    <brief_title>Lidocaine Administration Using STAR Particles</brief_title>
    <official_title>Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Children's Healthcare of Atlanta</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic&#xD;
        with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly&#xD;
        to provide local anesthesia or numbing in a specific area? Research participants will provide&#xD;
        feedback on how quickly the STAR particles with the numbing gel can provide anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this study is to find out if the combination of STAR particles with numbing&#xD;
        cream can deliver anesthesia faster than applying the cream by itself. STAR particles are&#xD;
        very small particles with microneedles on the surface that can increase and create small&#xD;
        punctures in the skin. The small punctures should allow for the numbing cream to work more&#xD;
        quickly and allow the area to become numb more quickly.&#xD;
  &#xD;
        The study will work towards finding out what combination of numbing cream and STAR particles&#xD;
        will work more quickly than the numbing cream that is already used in children.&#xD;
  &#xD;
        Participants will have 1 visit when they will apply the numbing gel, have a gel with STAR&#xD;
        particles mixed in applied, and have a Pin-Prick Pain test done to evaluate the numbing gel.&#xD;
        The study team will also use a device called a vapometer to measure how much water is being&#xD;
        lost from the skin at the application site before and after the STAR particle application.&#xD;
        Participants will have follow-up calls 24 hours, 1 week, and 30 days after the visit to ask&#xD;
        them about any changes to the skin where the STAR particles were applied.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 19, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to achieve local anesthesia</measure>
      <time_frame>From STAR particles application until anesthesia is achieved up to 1 hour</time_frame>
      <description>The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia: TSP - Time to achieve anesthesia for STAR particles compared to TLET - Time to achieve anesthesia for application of topical lidocaine (LET gel).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Application site pain assessment</measure>
      <time_frame>1 hour after application</time_frame>
      <description>The application site pain assessment will be measured by using the visual analog scale (VAS). The VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the transepidermal water loss (TEWL)</measure>
      <time_frame>Baseline and immediately after application</time_frame>
      <description>The trans epidermal water loss (TEWL) will be measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with acute skin reactions (ASRs) post-STAR particle application</measure>
      <time_frame>1 hour after application up to 1 week</time_frame>
      <description>The particle application sites will be observed for acute skin reactions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of adverse events (AEs)</measure>
      <time_frame>1 hour after application up to 30 days after application</time_frame>
      <description>All AEs will be documented starting after lidocaine application up to 30 days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of serious adverse events (SAEs)</measure>
      <time_frame>1 hour after application up to 30 days after application</time_frame>
      <description>All SAEs will be documented starting after lidocaine application up to 30 days.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Anesthesia, Local</condition>
    <arm_group>
      <arm_group_label>LET Gel after STAR Particle Application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Children, adolescents, and young adults will receive local anesthesia via different methods: STAR particles prior to lidocaine compared to topical lidocaine without the use of the STAR particles device.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>LET Gel after STAR Particle Application (Right Arm)</intervention_name>
      <description>STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles will vary in concentration and length in order to find the optimal concentration and length. Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the mid-forearm at two locations (right antecubital fossa and wrist). Immediately after application of the STAR particles, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine after STAR particle application (TSP) at both sites.</description>
      <arm_group_label>LET Gel after STAR Particle Application</arm_group_label>
      <other_name>STAR Particle preparation</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>LET Gel Application without STAR Particle Application (Left Arm)</intervention_name>
      <description>Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying aloe gel (CONTROL) to the volar surface of the mid-forearm at two locations (right antecubital fossa and right wrist). Immediately after application of the aloe gel, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed by the investigator every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine without STAR particle application (TLET) at both sites.</description>
      <arm_group_label>LET Gel after STAR Particle Application</arm_group_label>
      <other_name>Aloe Gel</other_name>
      <other_name>Topical Lidocaine</other_name>
      <other_name>Control</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children, adolescents, and young adults, 10 - 21 years of age. The first 2 patients&#xD;
               will be between the ages of 18-21 years old.&#xD;
  &#xD;
            -  In good general health as determined by a medical history&#xD;
  &#xD;
            -  Willing to provide informed assent with parental consent and follow study requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Is chronically using pain medication&#xD;
  &#xD;
            -  Has a plan to move to another location in the next 12 months or foresees any other&#xD;
               reason that participation in the study would be disrupted during the next 12 months&#xD;
  &#xD;
            -  Has skin disorders or skin allergies&#xD;
  &#xD;
            -  Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium&#xD;
               Dioxide)&#xD;
  &#xD;
            -  Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle&#xD;
               application&#xD;
  &#xD;
            -  Has known neurological conditions that might affect sensory function or perception of&#xD;
               pain&#xD;
  &#xD;
            -  Has any condition (social or medical), which in the opinion of the investigator would&#xD;
               make study participation unsafe, would interfere with adherence to the clinical study&#xD;
               requirements, or would complicate data interpretation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eric I Felner, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eric I Felner, MD, MS</last_name>
      <phone>404-785-0935</phone>
      <email>efelner@emory.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Emory Children's Center</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eric I Felner, MD, MS</last_name>
        <phone>404-785-0935</phone>
        <email>efelner@emory.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Eric Felner</investigator_full_name>
      <investigator_title>Professor of Pediatrics</investigator_title>
    </responsible_party>
    <keyword>STAR particles</keyword>
    <keyword>Topical Lidocaine</keyword>
    <keyword>Skin</keyword>
    <keyword>Pediatrics</keyword>
    <keyword>Adolescents</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034340
  org study id: STUDY00002928
  nct id: NCT06034340
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic
        with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly
        to provide local anesthesia or numbing in a specific area? Research participants will provide
        feedback on how quickly the STAR particles with the numbing gel can provide anesthesia.
  The objective of this study is to find out if the combination of STAR particles with numbing
        cream can deliver anesthesia faster than applying the cream by itself. STAR particles are
        very small particles with microneedles on the surface that can increase and create small
        punctures in the skin. The small punctures should allow for the numbing cream to work more
        quickly and allow the area to become numb more quickly.
  
        The study will work towards finding out what combination of numbing cream and STAR particles
        will work more quickly than the numbing cream that is already used in children.
  
        Participants will have 1 visit when they will apply the numbing gel, have a gel with STAR
        particles mixed in applied, and have a Pin-Prick Pain test done to evaluate the numbing gel.
        The study team will also use a device called a vapometer to measure how much water is being
        lost from the skin at the application site before and after the STAR particle application.
        Participants will have follow-up calls 24 hours, 1 week, and 30 days after the visit to ask
        them about any changes to the skin where the STAR particles were applied.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time to achieve local anesthesia
  time frame: From STAR particles application until anesthesia is achieved up to 1 hour
  description: The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia: TSP - Time to achieve anesthesia for STAR particles compared to TLET - Time to achieve anesthesia for application of topical lidocaine (LET gel).
  measure: Application site pain assessment
  time frame: 1 hour after application
  description: The application site pain assessment will be measured by using the visual analog scale (VAS). The VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
  measure: Change in the transepidermal water loss (TEWL)
  time frame: Baseline and immediately after application
  description: The trans epidermal water loss (TEWL) will be measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel.
  measure: Number of participants with acute skin reactions (ASRs) post-STAR particle application
  time frame: 1 hour after application up to 1 week
  description: The particle application sites will be observed for acute skin reactions.
  measure: Assessment of adverse events (AEs)
  time frame: 1 hour after application up to 30 days after application
  description: All AEs will be documented starting after lidocaine application up to 30 days.
  measure: Assessment of serious adverse events (SAEs)
  time frame: 1 hour after application up to 30 days after application
  description: All SAEs will be documented starting after lidocaine application up to 30 days.
  arm group label: LET Gel after STAR Particle Application
  arm group type: Experimental
  description: Children, adolescents, and young adults will receive local anesthesia via different methods: STAR particles prior to lidocaine compared to topical lidocaine without the use of the STAR particles device.
  intervention type: Device
  intervention name: LET Gel after STAR Particle Application (Right Arm)
  description: STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles will vary in concentration and length in order to find the optimal concentration and length. Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the mid-forearm at two locations (right antecubital fossa and wrist). Immediately after application of the STAR particles, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine after STAR particle application (TSP) at both sites.
  arm group label: LET Gel after STAR Particle Application
  other name: STAR Particle preparation
  intervention type: Other
  intervention name: LET Gel Application without STAR Particle Application (Left Arm)
  description: Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying aloe gel (CONTROL) to the volar surface of the mid-forearm at two locations (right antecubital fossa and right wrist). Immediately after application of the aloe gel, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed by the investigator every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine without STAR particle application (TLET) at both sites.
  arm group label: LET Gel after STAR Particle Application
  other name: Aloe Gel
  other name: Topical Lidocaine
  other name: Control
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 21 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eric I Felner, MD, MS
  role: Principal Investigator
  affiliation: Emory University
  last name: Eric I Felner, MD, MS
  phone: 404-785-0935
  email: efelner@emory.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Eric Felner
  investigator title: Professor of Pediatrics
  mesh term: Lidocaine
  sharing ipd: No