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/NCT06004973</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00005486</org_study_id>
      <nct_id>NCT06004973</nct_id>
    </id_info>
    <brief_title>Aldena STAR Particles</brief_title>
    <official_title>Usability of STAR Particles in Healthy Volunteers: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        The objective of this study is to find out the best method of applying STAR particles to the&#xD;
        skin. STAR particles are very small particles with microneedles on the surface that can&#xD;
        increase and create small punctures in the skin.&#xD;
  &#xD;
        The small punctures should allow for different topical medications to work more effectively.&#xD;
        This is important to understand the potential use of STAR particles in future topical&#xD;
        medications. This study will not use any medication with active ingredients.&#xD;
  &#xD;
        The study will include healthy adult participants. The first visit will be for the collection&#xD;
        of medical information and assessing eligibility in the study. The second visit will have the&#xD;
        application of STAR particles on different areas of the arm and hand with different pressures&#xD;
        to see what the most effective method of application is. The skin will be evaluated after the&#xD;
        application and surveys will be collected on the tolerability of the application.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this study is to identify the most efficacious pressure of administration and the&#xD;
        minimum number of rubbing cycles necessary to perforate the stratum corneum (the outermost&#xD;
        layer of the skin).&#xD;
  &#xD;
        Many medical indications are treated through the topical application of a therapeutic&#xD;
        compound formulated into a gel, cream, ointment, or lotion (e.g., eczema, psoriasis, actinic&#xD;
        keratosis, cutaneous warts, etc.). This is especially true in dermatology in which the skin&#xD;
        is often the primary site of action. Topicals (i.e., drugs applied to the skin's surface)&#xD;
        allow patients to easily self-apply these therapies without the need for painful or&#xD;
        difficult-to-use medical technologies (e.g., hypodermic needles) or the risks associated with&#xD;
        systemic exposure to a drug (e.g., oral, intravenous, or intramuscular administration).&#xD;
  &#xD;
        Despite the advantages associated with topical delivery, the skin serves as a barrier in the&#xD;
        transport of most external compounds. There are several techniques to overcome the skin&#xD;
        barrier. There have been several studies to increase skin permeability such as chemical,&#xD;
        biochemical, and physical methods. However, chemical and biochemical methods do not appear to&#xD;
        be broadly useful for the delivery of large molecule therapeutics (e.g., peptides, proteins,&#xD;
        genetic material) across the skin. STAR particles are millimeter-scale particles with&#xD;
        micron-scale projections made of biocompatible materials that painlessly disrupt the stratum&#xD;
        corneum. As STAR particles are rubbed on the skin, their microscopic projections create&#xD;
        micron-scale pores in the stratum corneum to increase skin permeability to topical compounds&#xD;
        independent of physicochemical properties. After the arms of the STAR particle puncture the&#xD;
        skin, the elastic forces of the skin push the particles out. The first 10 participants will&#xD;
        receive the 8 interventions (different application pressures) plus the control (Site and&#xD;
        treatment will not be randomly assigned on the arm) by the investigator. In addition, two&#xD;
        applications of STAR particles will be applied to one of the hands. After these participants&#xD;
        have completed the study, an interim analysis will be performed. At this point, a decision&#xD;
        will be made by the investigator to determine if changes in STAR particle administration will&#xD;
        be implemented for the next 10 participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in conditions for the administration of STAR particles to penetrate the stratum corneum</measure>
      <time_frame>Before application, 20 minutes after application, and 30 minutes after application</time_frame>
      <description>Identification of the most efficacious conditions for the administration of STAR particles will be measured by the number of perforations per cm2 using Gentian Violet (GV) staining and trans-epidermal water loss (TEWL) measurement before and after application of STAR particles [(T0 (before), T20 (after), T30, GV)].</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluate the sensation and pain during and after application of STAR particle</measure>
      <time_frame>Immediately After STAR particles application</time_frame>
      <description>Participants will complete a tolerability questionnaire with questions regarding a list of specific symptoms. Did you experience any of the following (yes/no)? If yes, how strong (very slight, slight, moderate, strong, very strong) was the sensation in the different area or sites? Was the sensation comfortable, bothersome (yes/no)?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess standard adverse event (AE)</measure>
      <time_frame>Enrollment until 5 days after the last visit</time_frame>
      <description>Removal &amp; Disposal Questionnaire</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Assess potential adverse events after removal</measure>
      <time_frame>After STAR particles removal up to 30 days</time_frame>
      <description>A visual inspection of the residual STAR particles will be performed after removal to assess potential adverse events. Participants will report any adverse events until 30 days after removal.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>STAR Particles</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned on the arm) by the investigator.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>STAR Particles</intervention_name>
      <description>A 1.5-gram dose of STAR particles (10% concentration in aloe vera ointment) will be applied to the eight application sites (forearm and hand) and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated.</description>
      <arm_group_label>STAR Particles</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult, 18 - 39 years of age&#xD;
  &#xD;
            -  In good general health as determined by a medical history&#xD;
  &#xD;
            -  Willing and able to provide informed consent and follow all study requirements&#xD;
  &#xD;
            -  Not pregnant and does not desire to become pregnant in the subsequent two months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a known allergy or sensitivity to aloe vera or alumina&#xD;
  &#xD;
            -  Has any skin disorders or skin allergies&#xD;
  &#xD;
            -  Has any medical condition that may affect skin or skin sensation&#xD;
  &#xD;
            -  Has abnormal (e.g., tattooed) skin at forearms&#xD;
  &#xD;
            -  Has known neurological condition affecting sensory function or perception of pain&#xD;
  &#xD;
            -  Has inflammatory bowel disease&#xD;
  &#xD;
            -  Has applied skin ointment or cream to forearms in the previous 24 hours&#xD;
  &#xD;
            -  Has a major congenital or chromosomal abnormality known to affect the skin&#xD;
  &#xD;
            -  Has taken pain medication in the last 24 hours&#xD;
  &#xD;
            -  Is currently participating in another interventional clinical trial&#xD;
  &#xD;
            -  Has previously participated in a STAR particle interventional clinical trial&#xD;
  &#xD;
            -  Is pregnant or wishing to be pregnant&#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>18 Years</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eric I Felner, MD, MSCR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eric I Felner, MD, MSCR</last_name>
      <phone>404-727-7651</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>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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 Medicine</investigator_title>
    </responsible_party>
    <keyword>STAR particles</keyword>
    <keyword>Skin</keyword>
    <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/NCT06004973
  org study id: STUDY00005486
  nct id: NCT06004973
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The objective of this study is to find out the best method of applying STAR particles to the
        skin. 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 different topical medications to work more effectively.
        This is important to understand the potential use of STAR particles in future topical
        medications. This study will not use any medication with active ingredients.
  
        The study will include healthy adult participants. The first visit will be for the collection
        of medical information and assessing eligibility in the study. The second visit will have the
        application of STAR particles on different areas of the arm and hand with different pressures
        to see what the most effective method of application is. The skin will be evaluated after the
        application and surveys will be collected on the tolerability of the application.
  The goal of this study is to identify the most efficacious pressure of administration and the
        minimum number of rubbing cycles necessary to perforate the stratum corneum (the outermost
        layer of the skin).
  
        Many medical indications are treated through the topical application of a therapeutic
        compound formulated into a gel, cream, ointment, or lotion (e.g., eczema, psoriasis, actinic
        keratosis, cutaneous warts, etc.). This is especially true in dermatology in which the skin
        is often the primary site of action. Topicals (i.e., drugs applied to the skin's surface)
        allow patients to easily self-apply these therapies without the need for painful or
        difficult-to-use medical technologies (e.g., hypodermic needles) or the risks associated with
        systemic exposure to a drug (e.g., oral, intravenous, or intramuscular administration).
  
        Despite the advantages associated with topical delivery, the skin serves as a barrier in the
        transport of most external compounds. There are several techniques to overcome the skin
        barrier. There have been several studies to increase skin permeability such as chemical,
        biochemical, and physical methods. However, chemical and biochemical methods do not appear to
        be broadly useful for the delivery of large molecule therapeutics (e.g., peptides, proteins,
        genetic material) across the skin. STAR particles are millimeter-scale particles with
        micron-scale projections made of biocompatible materials that painlessly disrupt the stratum
        corneum. As STAR particles are rubbed on the skin, their microscopic projections create
        micron-scale pores in the stratum corneum to increase skin permeability to topical compounds
        independent of physicochemical properties. After the arms of the STAR particle puncture the
        skin, the elastic forces of the skin push the particles out. The first 10 participants will
        receive the 8 interventions (different application pressures) plus the control (Site and
        treatment will not be randomly assigned on the arm) by the investigator. In addition, two
        applications of STAR particles will be applied to one of the hands. After these participants
        have completed the study, an interim analysis will be performed. At this point, a decision
        will be made by the investigator to determine if changes in STAR particle administration will
        be implemented for the next 10 participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in conditions for the administration of STAR particles to penetrate the stratum corneum
  time frame: Before application, 20 minutes after application, and 30 minutes after application
  description: Identification of the most efficacious conditions for the administration of STAR particles will be measured by the number of perforations per cm2 using Gentian Violet (GV) staining and trans-epidermal water loss (TEWL) measurement before and after application of STAR particles [(T0 (before), T20 (after), T30, GV)].
  measure: Evaluate the sensation and pain during and after application of STAR particle
  time frame: Immediately After STAR particles application
  description: Participants will complete a tolerability questionnaire with questions regarding a list of specific symptoms. Did you experience any of the following (yes/no)? If yes, how strong (very slight, slight, moderate, strong, very strong) was the sensation in the different area or sites? Was the sensation comfortable, bothersome (yes/no)?
  measure: Assess standard adverse event (AE)
  time frame: Enrollment until 5 days after the last visit
  description: Removal & Disposal Questionnaire
  measure: Assess potential adverse events after removal
  time frame: After STAR particles removal up to 30 days
  description: A visual inspection of the residual STAR particles will be performed after removal to assess potential adverse events. Participants will report any adverse events until 30 days after removal.
  arm group label: STAR Particles
  arm group type: Experimental
  description: Participants will receive the 8 interventions (different application pressures) plus the control (Site and treatment will not be randomly assigned on the arm) by the investigator.
  intervention type: Device
  intervention name: STAR Particles
  description: A 1.5-gram dose of STAR particles (10% concentration in aloe vera ointment) will be applied to the eight application sites (forearm and hand) and 100 mg of aloe vera will be applied to the control site on one of the forearms. Two rubbing cycles (20 and 30 cycles at 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be evaluated.
  arm group label: STAR Particles
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 39 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eric I Felner, MD, MSCR
  role: Principal Investigator
  affiliation: Emory University
  last name: Eric I Felner, MD, MSCR
  phone: 404-727-7651
  email: efelner@emory.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Eric Felner
  investigator title: Professor of Medicine
  sharing ipd: No