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/NCT06036589</url>
    </required_header>
    <id_info>
      <org_study_id>N-20190062 3rd project</org_study_id>
      <nct_id>NCT06036589</nct_id>
    </id_info>
    <brief_title>Characterization of Bovine Adrenal Medulla as a Model of Non-histaminergic Itch</brief_title>
    <official_title>Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aalborg University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aalborg University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic&#xD;
        itch induced by BAM8-22&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic&#xD;
        itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human&#xD;
        body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a&#xD;
        TRPA1 agonist&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 10, 2022</start_date>
    <completion_date type="Actual">October 30, 2022</completion_date>
    <primary_completion_date type="Actual">May 30, 2022</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>Sequential Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>superficial blood perfusion</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>is measured by a speckle contrast imager (FLPI, Moor Instruments, England)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Warm Detection Threshold</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heat Pain threshold</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cold Detection Threshold</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cold Pain threshold</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain supra-threshold heat Stimuli</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hyperknesis</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (5-30 milliNewton of force). participants will rate the itch sensation induced by stimuli with von Frey filaments on an numerical rating scale from 0 to 10</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mechanical pain threshold</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications. it will be determinate a threshold corresponding to the force of the pinprick (mN) from which participants start to feel pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mechanical pain sensitivity</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications</description>
    </primary_outcome>
    <primary_outcome>
      <measure>itch rating</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates &quot;no itch&quot; and 100 indicates &quot;worst imaginable itch&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>pain rating</measure>
      <time_frame>change from baseline, up to 10 minutes after the application</time_frame>
      <description>the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates &quot;no pain&quot; and 100 indicates &quot;worst imaginable pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">25</enrollment>
    <condition>Itch</condition>
    <arm_group>
      <arm_group_label>CA application + BAM8-22</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>CA application and vehicle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CA and BAM8-22</intervention_name>
      <description>CA (tran-cinnamaldheyde) solution (in ethanol 5%) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules</description>
      <arm_group_label>CA application + BAM8-22</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vehicle and BAM8-22 application</intervention_name>
      <description>Vehicle (ethanol) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules</description>
      <arm_group_label>CA application + BAM8-22</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CA</intervention_name>
      <description>CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm</description>
      <arm_group_label>CA application and vehicle</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>vehicle</intervention_name>
      <description>Vehicle (ethanol) application and inactivate cowhage spicules will be applied to a previously determined area on the volar forearm</description>
      <arm_group_label>CA application and vehicle</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy men and women&#xD;
  &#xD;
            -  18-60 years&#xD;
  &#xD;
            -  Speak and understand English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Drug addiction defined as any use of cannabis, opioids or other drugs&#xD;
  &#xD;
            -  Previous or current history of neurological, dermatological, immunological&#xD;
               musculoskeletal, cardiac disorder or mental illnesses that may affect the results&#xD;
               (e.g. neuropathy, muscular pain in the upper extremities, etc.)&#xD;
  &#xD;
            -  Moles, wounds, scars or tattoos in the area to be treated or tested&#xD;
  &#xD;
            -  Lack of ability to cooperate •&#xD;
  &#xD;
            -  Current use of medications that may affect the trial such as antihistamines and pain&#xD;
               killers.&#xD;
  &#xD;
            -  Skin diseases&#xD;
  &#xD;
            -  Consumption of alcohol or painkillers 24 hours before the study days and between these&#xD;
  &#xD;
            -  Acute or chronic pain&#xD;
  &#xD;
            -  Participation in other trials within 1 week of study entry (4 weeks in the case of&#xD;
               pharmaceutical trials)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Aalborg University</name>
        <address>
          <city>Aalborg</city>
          <zip>9000</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 9, 2022</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aalborg University</investigator_affiliation>
      <investigator_full_name>Giulia Erica Aliotta</investigator_full_name>
      <investigator_title>Principal Investigator, PhD fellow</investigator_title>
    </responsible_party>
    <!-- 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/NCT06036589
  org study id: N-20190062 3rd project
  nct id: NCT06036589
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic
        itch induced by BAM8-22
  With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic
        itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human
        body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a
        TRPA1 agonist
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: superficial blood perfusion
  time frame: change from baseline, up to 10 minutes after the application
  description: is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
  measure: Warm Detection Threshold
  time frame: change from baseline, up to 10 minutes after the application
  description: the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
  measure: Heat Pain threshold
  time frame: change from baseline, up to 10 minutes after the application
  description: the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
  measure: Cold Detection Threshold
  time frame: change from baseline, up to 10 minutes after the application
  description: the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
  measure: Cold Pain threshold
  time frame: change from baseline, up to 10 minutes after the application
  description: the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
  measure: Pain supra-threshold heat Stimuli
  time frame: change from baseline, up to 10 minutes after the application
  description: the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
  measure: hyperknesis
  time frame: change from baseline, up to 10 minutes after the application
  description: measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (5-30 milliNewton of force). participants will rate the itch sensation induced by stimuli with von Frey filaments on an numerical rating scale from 0 to 10
  measure: mechanical pain threshold
  time frame: change from baseline, up to 10 minutes after the application
  description: is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications. it will be determinate a threshold corresponding to the force of the pinprick (mN) from which participants start to feel pain
  measure: mechanical pain sensitivity
  time frame: change from baseline, up to 10 minutes after the application
  description: is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications
  measure: itch rating
  time frame: change from baseline, up to 10 minutes after the application
  description: the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"
  measure: pain rating
  time frame: change from baseline, up to 10 minutes after the application
  description: the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no pain" and 100 indicates "worst imaginable pain
  arm group label: CA application + BAM8-22
  arm group type: Experimental
  arm group label: CA application and vehicle
  arm group type: Experimental
  intervention type: Drug
  intervention name: CA and BAM8-22
  description: CA (tran-cinnamaldheyde) solution (in ethanol 5%) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
  arm group label: CA application + BAM8-22
  intervention type: Drug
  intervention name: Vehicle and BAM8-22 application
  description: Vehicle (ethanol) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
  arm group label: CA application + BAM8-22
  intervention type: Drug
  intervention name: CA
  description: CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm
  arm group label: CA application and vehicle
  intervention type: Drug
  intervention name: vehicle
  description: Vehicle (ethanol) application and inactivate cowhage spicules will be applied to a previously determined area on the volar forearm
  arm group label: CA application and vehicle
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Aalborg University
  investigator full name: Giulia Erica Aliotta
  investigator title: Principal Investigator, PhD fellow