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/NCT05991674</url>
    </required_header>
    <id_info>
      <org_study_id>131/2023</org_study_id>
      <nct_id>NCT05991674</nct_id>
    </id_info>
    <brief_title>A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques</brief_title>
    <official_title>A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Andreas Syggros Hospital of Venereal and Dermatological Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Andreas Syggros Hospital of Venereal and Dermatological Diseases</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to look into the patterns of sensitization to figure out how&#xD;
        allergic contact dermatitis (ACD), individual susceptibility, and patient characteristics are&#xD;
        connected. The joint application of classic statistics and machine learning methods will&#xD;
        reveal the relationship between contact dermatitis expressions and several clinical&#xD;
        characteristics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>MOAHLFAP index</measure>
      <time_frame>Clinical examination at baseline (0h)</time_frame>
      <description>The MOAHLFAP index included characteristics of patients such as M (male), O (occupational dermatitis (OD)), A (atopic dermatitis (AD)), H (hand dermatitis (HD)), L (leg dermatitis (LD)), F (face dermatitis (FD)), A (age 40+), and P (at least one positive). Further on, we have used the criterion of trunk dermatitis (TD) and generalized dermatitis in our patients. This index contributes to the group description, stratifying the results as to the presence of sensitization prevalence and provides a multifunctional analysis in order to estimate the risk of sensitization (for example, being male with occupational contact dermatitis)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Contact Dermatitis Research Group (ICDRG) scale</measure>
      <time_frame>48 hours (Day 2) and 72 hours (Day 3) after the application of patch test</time_frame>
      <description>According to the International Contact Dermatitis Research Group (ICDRG) guidelines, the skin reactions are assessed as positive/allergic in terms of intesity and morphology lesions on a scale of (i) weak +, (ii) strong ++, and (iii) extreme +++, while everything else as negative (including also the irritant reactions).This is assessed as the patch test result.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antera 3D camera (Miravex, Dublin, Ireland)</measure>
      <time_frame>0h (baseline), 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test</time_frame>
      <description>The skin condition is evaluated by the Antera 3D camera (Miravex, Dublin, Ireland) at baseline (0h), 48h and 72h after the first exposure to allergens. Antera 3D uses an innovative optical method and complex mathematical algorithms to acquire images in three dimensions. This makes it possible to extract data from images related to the three-dimensional shape of the skin, which allows the monitoring of changes over time. Hemoglobin concentration, skin texture and elevation were assessed with Antera 3D software (Miravex, Dublin, Ireland). The indications were recorded in arbitrary units.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Allergic Contact Dermatitis</condition>
    <arm_group>
      <arm_group_label>Allergic Contact Dermatitis Patients</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>patch test for diagnosing allergic contact dermatitis</intervention_name>
      <description>European Baseline Series (EBS) System of allergens</description>
      <arm_group_label>Allergic Contact Dermatitis Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patch test findings from 80 ACD patients will be gathered at the National Reference Center&#xD;
          for Occupational Dermatoses &quot;Andreas Syggros&quot; Hospital's Laboratory for Patch Testing.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Eligible patients were adults diagnosed with dermatitis who had a positive patch test&#xD;
          result on the chemical panel of Baseline Series of Allergens.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Although there is no consensus for the definitive exclusion criteria from a patch testing,&#xD;
          most studies agree that the chronic use of anti-inflammatory treatments, corticosteroids,&#xD;
          and cyclosporine, high UV exposure and other chronic dermatoses are factors that might&#xD;
          produce false- positive or false- negative results and thus should be avoided.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aikaterini Kyritsi</last_name>
      <phone>+30 2107274027</phone>
      <email>akyrits@pharm.uoa.gr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Georgia Gogkla</name>
        <address>
          <city>Athens</city>
          <state>Attica</state>
          <zip>11621</zip>
          <country>Greece</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Georgia Gogkla</last_name>
        <phone>+30 210 7210839</phone>
        <email>grgkokla@yahoo.gr</email>
      </contact>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Andreas Syggros Hospital of Venereal and Dermatological Diseases</investigator_affiliation>
      <investigator_full_name>GEORGIA KOKLA</investigator_full_name>
      <investigator_title>Chief Administrative Secretary</investigator_title>
    </responsible_party>
    <keyword>Contact Sensitization</keyword>
    <keyword>Patch Test</keyword>
    <keyword>Machine Learning</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Dermatitis, Contact</mesh_term>
      <mesh_term>Dermatitis, Allergic Contact</mesh_term>
    </condition_browse>
    <!-- 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/NCT05991674
  org study id: 131/2023
  nct id: NCT05991674
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to look into the patterns of sensitization to figure out how
        allergic contact dermatitis (ACD), individual susceptibility, and patient characteristics are
        connected. The joint application of classic statistics and machine learning methods will
        reveal the relationship between contact dermatitis expressions and several clinical
        characteristics.
  observational model: Cohort
  time perspective: Prospective
  measure: MOAHLFAP index
  time frame: Clinical examination at baseline (0h)
  description: The MOAHLFAP index included characteristics of patients such as M (male), O (occupational dermatitis (OD)), A (atopic dermatitis (AD)), H (hand dermatitis (HD)), L (leg dermatitis (LD)), F (face dermatitis (FD)), A (age 40+), and P (at least one positive). Further on, we have used the criterion of trunk dermatitis (TD) and generalized dermatitis in our patients. This index contributes to the group description, stratifying the results as to the presence of sensitization prevalence and provides a multifunctional analysis in order to estimate the risk of sensitization (for example, being male with occupational contact dermatitis)
  measure: International Contact Dermatitis Research Group (ICDRG) scale
  time frame: 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test
  description: According to the International Contact Dermatitis Research Group (ICDRG) guidelines, the skin reactions are assessed as positive/allergic in terms of intesity and morphology lesions on a scale of (i) weak +, (ii) strong ++, and (iii) extreme +++, while everything else as negative (including also the irritant reactions).This is assessed as the patch test result.
  measure: Antera 3D camera (Miravex, Dublin, Ireland)
  time frame: 0h (baseline), 48 hours (Day 2) and 72 hours (Day 3) after the application of patch test
  description: The skin condition is evaluated by the Antera 3D camera (Miravex, Dublin, Ireland) at baseline (0h), 48h and 72h after the first exposure to allergens. Antera 3D uses an innovative optical method and complex mathematical algorithms to acquire images in three dimensions. This makes it possible to extract data from images related to the three-dimensional shape of the skin, which allows the monitoring of changes over time. Hemoglobin concentration, skin texture and elevation were assessed with Antera 3D software (Miravex, Dublin, Ireland). The indications were recorded in arbitrary units.
  arm group label: Allergic Contact Dermatitis Patients
  intervention type: Diagnostic Test
  intervention name: patch test for diagnosing allergic contact dermatitis
  description: European Baseline Series (EBS) System of allergens
  arm group label: Allergic Contact Dermatitis Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aikaterini Kyritsi
  phone: +30 2107274027
  email: akyrits@pharm.uoa.gr
  facility: 
  status: Recruiting
  contact: 
  country: Greece
  responsible party type: Principal Investigator
  investigator affiliation: Andreas Syggros Hospital of Venereal and Dermatological Diseases
  investigator full name: GEORGIA KOKLA
  investigator title: Chief Administrative Secretary
  mesh term: Dermatitis
  mesh term: Dermatitis, Contact
  mesh term: Dermatitis, Allergic Contact