<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/NCT01675349</url>
  </required_header>
  <id_info>
    <org_study_id>6062 -PR-PRI-195</org_study_id>
    <nct_id>NCT01675349</nct_id>
  </id_info>
  <brief_title>Biological Standardization of Chenopodium Album Allergen Extract</brief_title>
  <official_title>Biological Standardization of Chenopodium Album Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratorios Leti, S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratorios Leti, S.L.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the biologic activity of a Chenopodium album&#xD;
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house&#xD;
      reference preparation (IHRP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open, unblinded and non-randomized biological assay. The study design is a slight&#xD;
      modification of the recommendations proposed by the Nordic Guidelines.&#xD;
&#xD;
      Four concentrations of Chenopodium album allergen extract, together with a positive and&#xD;
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol&#xD;
      saline solution, respectively, will be tested in every patient in duplicate on the volar&#xD;
      surface of the forearm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 2</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.</measure>
    <time_frame>15-20 min after application</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Allergy to Chenopodium Album</condition>
  <arm_group>
    <arm_group_label>Chenopodium album allergen extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prick test Chenopodium album allergen extract</intervention_name>
    <description>This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.&#xD;
Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.</description>
    <arm_group_label>Chenopodium album allergen extract</arm_group_label>
    <other_name>Chenopodium album allergen extract,</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided written informed consent, appropriately signed and dated by the&#xD;
             subject (or legal representative, if applicable).&#xD;
&#xD;
          -  Subject can be male or female of any race and ethnic group.&#xD;
&#xD;
          -  Age &gt; and =18 years and &lt; and =60 years at the study inclusion day.&#xD;
&#xD;
          -  Positive skin prick test with a standardized commercially available preparation of&#xD;
             chenopodium album allergen extract.&#xD;
&#xD;
          -  A positive test for specific IgE to chenopodium album (CAP-RAST major or equal to 2).&#xD;
&#xD;
          -  Allergic symptoms during the pollen season of Chenopodium album.&#xD;
&#xD;
          -  Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis&#xD;
             and/or asthma) from Chenopodium album.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunotherapy in the past 5 years with an allergen preparation known to interfere with&#xD;
             the allergen to be tested.&#xD;
&#xD;
          -  Use of drugs that may interfere with the skin reactions (e.g., antihistamines).&#xD;
&#xD;
          -  Treatment with any of the following medications: tricyclic or tetracyclic&#xD;
&#xD;
             o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of&#xD;
             corticoids both via oral or parenteral, in repeated patterns and intermittent (&gt; 10&#xD;
             mg/día de prednisone or equivalent).&#xD;
&#xD;
          -  Women who are pregnant or period of breastfeeding and women with a pregnancy test&#xD;
             positive during the visit 2, prior to the prick test.&#xD;
&#xD;
          -  Dermographism affecting the skin area at the test site at either study visit.&#xD;
&#xD;
          -  Atopic dermatitis affecting the skin area at the test site at either study visit.&#xD;
&#xD;
          -  Urticaria affecting the skin area at the test site at either study visit.&#xD;
&#xD;
          -  Diseases of the immune system relevant clinically, both autoimmune and&#xD;
             immunodeficiencies.&#xD;
&#xD;
          -  Serious diseases not controlled that may increase the risk for the safety of the&#xD;
             subjects involved in this study, including, but not limited to the following: heart&#xD;
             failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically&#xD;
             relevant kidney or liver diseases or hematological diseases.&#xD;
&#xD;
          -  Participation in any other clinical trial within 30 days (or 5 times the biological&#xD;
             half-life of the research of the study product, whichever is longer) prior to the&#xD;
             inclusion of the subject in this clinical trial.&#xD;
&#xD;
          -  Patients with diseases or conditions that limit the use of adrenaline (heart disease,&#xD;
             severe hypertension, ..)&#xD;
&#xD;
          -  Severe psychiatric, psychological or neurological disorders&#xD;
&#xD;
          -  Abuse of alcohol, drugs or medicines in the previous year.&#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>Lena Erbiti</last_name>
    <role>Study Chair</role>
    <affiliation>Laboratorios LETI, S.L.Unipersonal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General de Elche</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Adeslas</name>
      <address>
        <city>Córdoba</city>
        <zip>14006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>May 22, 2014</last_update_submitted>
  <last_update_submitted_qc>May 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Standardization</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Skin prick test</keyword>
  <!-- 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/NCT01675349
org study id: 6062 -PR-PRI-195
nct id: NCT01675349
lead sponsor: 
has dmc: No
The objective of this study is to determine the biologic activity of a Chenopodium album
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Chenopodium album allergen extract, together with a positive and
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol
      saline solution, respectively, will be tested in every patient in duplicate on the volar
      surface of the forearm.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
time frame: 15-20 min after application
arm group label: Chenopodium album allergen extract
arm group type: Experimental
description: Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
intervention type: Biological
intervention name: Prick test Chenopodium album allergen extract
description: This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
arm group label: Chenopodium album allergen extract
other name: Chenopodium album allergen extract,
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lena Erbiti
role: Study Chair
affiliation: Laboratorios LETI, S.L.Unipersonal
facility: 
facility: 
country: Spain
responsible party type: Sponsor