<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/NCT03820154</url>
  </required_header>
  <id_info>
    <org_study_id>CBauchert</org_study_id>
    <nct_id>NCT03820154</nct_id>
  </id_info>
  <brief_title>Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest</brief_title>
  <acronym>SPTTapeD1</acronym>
  <official_title>A Bridging Study Investigating the Diagnostic Equivalence of the SPT Tape in Comparison With the Conventional SPT Using ALK SoluprickR Allergen Extracts in Patients With Inhalation Allergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Claus Bachert BVBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof. Dr. Claus Bachert BVBA</source>
  <oversight_info>
    <has_dmc>No</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>
      Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for&#xD;
      the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for&#xD;
      representative common inhalant allergens to conventional SPT in terms of wheal reaction&#xD;
      positivity and overall safety. Tests are performed in patients who have a medical history of&#xD;
      relevant allergic rhinitis to any of the tested allergens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, single site bridging study. Subjects with a history of in-halation allergies&#xD;
      will be tested in parallel with the SPT Tape and with the conventional SPT procedure using&#xD;
      one forearm each.&#xD;
&#xD;
      In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is&#xD;
      applied on the two forearms one time only.&#xD;
&#xD;
      The following Soluprick® allergens and control solutions will be evaluated:&#xD;
&#xD;
      Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus,&#xD;
      D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT&#xD;
      and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the&#xD;
      same location and order on both arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Comparison of conventional Skin Prick Test vs. Tape SPT</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wheal diameters</measure>
    <time_frame>15 min</time_frame>
    <description>Maximal wheal diameter in millimeter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale on Comfort</measure>
    <time_frame>30 min</time_frame>
    <description>Visual Analogue Scale from 0-10 cm from &quot;not at all unpleasant&quot; to &quot;very unpleasant&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient' s preference</measure>
    <time_frame>30 min</time_frame>
    <description>Patients are asked to select the test they would prefer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Allergic Rhinitis</condition>
  <condition>Allergic Asthma</condition>
  <condition>Allergic Conjunctivitis</condition>
  <condition>Food Allergy</condition>
  <arm_group>
    <arm_group_label>Skin Prick Test TAPE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Skin Prick Test Tape is an innovative sterile &quot;all-in&quot; drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skin Prick Test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin Prick Test</intervention_name>
    <description>Skin Prick Testing with inhalant allergens</description>
    <arm_group_label>Skin Prick Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin Prick Test TAPE</intervention_name>
    <description>Skin Prick Testing with a Tape, integrating the allergens and needles</description>
    <arm_group_label>Skin Prick Test TAPE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects will be included only, if&#xD;
&#xD;
               1. they were informed about the nature, meaning, and scope of the study, and if they&#xD;
                  provided written consent to their participation&#xD;
&#xD;
               2. they are at least 18 years of age,&#xD;
&#xD;
               3. they have a history of allergic rhinitis due to grass and/or birch pollen, house&#xD;
                  dust mites, mugwort, cat and/or dog dander, and/or Alternaria since 2 years or&#xD;
                  more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects may not be included, if&#xD;
&#xD;
               1. they are impaired in understanding nature, meaning, and the scope of the study,&#xD;
                  or are incapable of giving written informed consent,&#xD;
&#xD;
               2. they suffer from diseases, show other conditions, or take medications, which&#xD;
                  might impact the skin tests or might contradict the correct conduct and&#xD;
                  evaluation of the study. In particular this includes the following:&#xD;
&#xD;
                    1. acute allergy,&#xD;
&#xD;
                    2. history of systemic reactions or hypersensitivity to allergens, abuse of&#xD;
                       drugs or alcohol&#xD;
&#xD;
                    3. severe diseases,&#xD;
&#xD;
                    4. impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria&#xD;
                       factitia) and acute chronic eczema in the skin test areas, skin infections,&#xD;
&#xD;
                    5. pregnancy or nursing,&#xD;
&#xD;
                    6. treatment with β-blockers,&#xD;
&#xD;
                    7. treatment with antihistamines or systemic glucocorticoids during the last 4&#xD;
                       weeks, with astemizol during the last 12 weeks,&#xD;
&#xD;
                    8. treatment with tricyclic antidepressants benzodiazepines, and neuroleptic&#xD;
                       drugs which may have histamine-antagonistic effects during the last 2 weeks,&#xD;
&#xD;
                    9. participation in any other medication study at the study time&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Wagenmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University pf Düsseldorf, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claus U Bachert, MD</last_name>
    <phone>+32473310902</phone>
    <email>claus.bachert@ugent.be</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 26, 2019</last_update_submitted>
  <last_update_submitted_qc>January 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_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/NCT03820154
org study id: CBauchert
nct id: NCT03820154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for
      the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for
      representative common inhalant allergens to conventional SPT in terms of wheal reaction
      positivity and overall safety. Tests are performed in patients who have a medical history of
      relevant allergic rhinitis to any of the tested allergens.
An open-label, single site bridging study. Subjects with a history of in-halation allergies
      will be tested in parallel with the SPT Tape and with the conventional SPT procedure using
      one forearm each.

      In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is
      applied on the two forearms one time only.

      The following Soluprick® allergens and control solutions will be evaluated:

      Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus,
      D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT
      and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the
      same location and order on both arms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of conventional Skin Prick Test vs. Tape SPT
primary purpose: Diagnostic
masking: None (Open Label)
measure: Wheal diameters
time frame: 15 min
description: Maximal wheal diameter in millimeter
measure: Visual Analogue Scale on Comfort
time frame: 30 min
description: Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
measure: Patient' s preference
time frame: 30 min
description: Patients are asked to select the test they would prefer
arm group label: Skin Prick Test TAPE
arm group type: Active Comparator
description: The Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names.
arm group label: Skin Prick Test
arm group type: Active Comparator
description: The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes.
intervention type: Diagnostic Test
intervention name: Skin Prick Test
description: Skin Prick Testing with inhalant allergens
arm group label: Skin Prick Test
intervention type: Diagnostic Test
intervention name: Skin Prick Test TAPE
description: Skin Prick Testing with a Tape, integrating the allergens and needles
arm group label: Skin Prick Test TAPE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Martin Wagenmann, MD
role: Principal Investigator
affiliation: University pf Düsseldorf, Germany
last name: Claus U Bachert, MD
phone: +32473310902
email: claus.bachert@ugent.be
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
sharing ipd: No