<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/NCT04500834</url>
  </required_header>
  <id_info>
    <org_study_id>SP20 11MP 301</org_study_id>
    <nct_id>NCT04500834</nct_id>
  </id_info>
  <brief_title>Metal Panel Allergen Patch Test Study</brief_title>
  <official_title>Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allerderm</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allerderm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Metal allergen patch test study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single application of an investigational patch test panel containing 11 hydrogel metal&#xD;
      allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will&#xD;
      be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch&#xD;
      test panels will be removed after being worn for approximately 48 hours. Study will require 6&#xD;
      visits over the course of 21 days; patch application, patch removal and 4 patch test site&#xD;
      evaluation visits at days 4, 7, 14 and 21.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 7, 2022</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>All subjects will be tested with 11 experimental metal allergens and corresponding metal allergens prepared in petrolatum</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens</measure>
    <time_frame>Days 3-21</time_frame>
    <description>Number of patch test responses will be recorded, concordance between hydrogel and petrolatum allergens will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of panel adhesion at visit 2 prior to panel removal</measure>
    <time_frame>Day 2</time_frame>
    <description>Number of subjects with excellent, good, poor or detached adhesion at panel removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of subject reported itching associated with test panels at visit 2 following panel removal</measure>
    <time_frame>Day 2</time_frame>
    <description>Number of subjects with no (none) weak, moderate or strong itching associated with test panels following panel removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.</measure>
    <time_frame>Day 2</time_frame>
    <description>Number of subjects with no (none) weak, moderate or strong burning associated with test panels following panel removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of tape irritation</measure>
    <time_frame>Day 21</time_frame>
    <description>Number of subjects with no (none) irritant or allergic tape irritation. Tape irritation is assessed at all visits. Investigator makes overall determination on day 21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of chip irritation</measure>
    <time_frame>Day 21</time_frame>
    <description>Number of subjects with no (none) irritant or allergic chip irritation. Chip irritation is assessed at all visits. Investigator makes overall determination on day 21.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atopic Dermatitis Eczema</condition>
  <arm_group>
    <arm_group_label>Positive reactions, Concordance with reference allergen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be patch tested with 11 experimental and 11 reference allergens. Rates of positive reactions will be evaluated using Cohen's kappa calculation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Metal Panel T.R.U.E. Test</intervention_name>
    <description>Diagnostic patch test</description>
    <arm_group_label>Positive reactions, Concordance with reference allergen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older.&#xD;
&#xD;
          2. Past positive patch test result within the past 10 years to one of the metal allergens&#xD;
             (other than nickel or gold), being tested on this study or strong suspicion of metal&#xD;
             contact allergy based on results of the Qualification Questionnaire, part 2 Type of&#xD;
             Metal Exposure.&#xD;
&#xD;
          3. Unable to become pregnant or willing to use an acceptable method of contraception to&#xD;
             prevent pregnancy if female of childbearing potential,&#xD;
&#xD;
               -  Inability to become pregnant would include all male subjects and female subjects&#xD;
                  who are postmenopausal for at least 1 year, or surgically sterile- have had a&#xD;
                  hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal&#xD;
                  ligation.&#xD;
&#xD;
               -  Acceptable methods of contraception include: 1) systemic birth control (i.e.,&#xD;
                  oral contraceptives, skin patch, vaginal ring, implant, injection, or&#xD;
                  intrauterine device (IUD), which contains either a hormone or copper); 2) double&#xD;
                  barrier method (i.e., diaphragm, cervical cap, sponge, condom with spermicide);&#xD;
                  3) IUD; 4) vasectomized partner; or 5) abstinence from sexual intercourse.&#xD;
                  Subject must agree to use acceptable contraception for the duration of the entire&#xD;
                  study.&#xD;
&#xD;
          4. Understands and signs the approved Informed Consent form which is consistent with all&#xD;
             institutional, local and national regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to&#xD;
             become pregnant during the course of the study. Breastfeeding may be resumed upon&#xD;
             completion of the study.&#xD;
&#xD;
          2. Topical treatment with corticosteroids or other immunosuppressive agents on or near&#xD;
             the test area 14 days prior to inclusion through the end of the subject's&#xD;
             participation in the study.&#xD;
&#xD;
          3. Systemic treatment with corticosteroids (equivalent to &gt; 10 mg prednisone) or other&#xD;
             immunosuppressive agents 14 days prior to inclusion through the end of the subject's&#xD;
             participation in the study. Inhaled treatments and steroidal nose or eye drops are&#xD;
             permitted.&#xD;
&#xD;
          4. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to&#xD;
             inclusion through the end of the subject's participation in the study.&#xD;
&#xD;
          5. Acute dermatitis outbreak or dermatitis on or near the test area on the back.&#xD;
&#xD;
          6. Known or suspected infection of the skin, joints or other site(s) associated with&#xD;
             metal exposure&#xD;
&#xD;
          7. Condition such as; fibromyalgia, chronic fatigue, depression, cognitive impairment,&#xD;
             flu-like symptoms, diarrhea and/or headache without at least one of the symptoms&#xD;
             related to metal exposure listed in Section 6.6.&#xD;
&#xD;
          8. Condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous&#xD;
             T-cell lymphoma that may confound the evaluation of allergic contact dermatitis.&#xD;
&#xD;
          9. Inability to comply with patch test study requirements including multiple return&#xD;
             visits and activity restrictions (e.g., protecting test panels from excess moisture&#xD;
             due to showering or vigorous activity).&#xD;
&#xD;
         10. Participation in a clinical trial of an investigational drug, treatment or device&#xD;
             during this study or 3 weeks prior to inclusion in this study.&#xD;
&#xD;
         11. An opinion of the Investigator that deems the potential subject to be non-compliant,&#xD;
             unable to return for study visits or complete the study as detailed in the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Curt Hamann, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Allerderm (dba SmartPractice)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathryn Shannon</last_name>
    <phone>602-225-0595</phone>
    <email>kshannon@smarthealth.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haley Jordon</last_name>
      <phone>502-585-9708</phone>
      <phone_ext>158</phone_ext>
      <email>hjordon@dsrtrials.com</email>
    </contact>
    <investigator>
      <last_name>Joseph Fowler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</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>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data with other researchers.</ipd_description>
  </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/NCT04500834
org study id: SP20 11MP 301
nct id: NCT04500834
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Metal allergen patch test study.
A single application of an investigational patch test panel containing 11 hydrogel metal
      allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will
      be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch
      test panels will be removed after being worn for approximately 48 hours. Study will require 6
      visits over the course of 21 days; patch application, patch removal and 4 patch test site
      evaluation visits at days 4, 7, 14 and 21.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects will be tested with 11 experimental metal allergens and corresponding metal allergens prepared in petrolatum
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens
time frame: Days 3-21
description: Number of patch test responses will be recorded, concordance between hydrogel and petrolatum allergens will be measured
measure: Evaluation of panel adhesion at visit 2 prior to panel removal
time frame: Day 2
description: Number of subjects with excellent, good, poor or detached adhesion at panel removal
measure: Evaluation of subject reported itching associated with test panels at visit 2 following panel removal
time frame: Day 2
description: Number of subjects with no (none) weak, moderate or strong itching associated with test panels following panel removal
measure: Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.
time frame: Day 2
description: Number of subjects with no (none) weak, moderate or strong burning associated with test panels following panel removal
measure: Evaluation of tape irritation
time frame: Day 21
description: Number of subjects with no (none) irritant or allergic tape irritation. Tape irritation is assessed at all visits. Investigator makes overall determination on day 21.
measure: Evaluation of chip irritation
time frame: Day 21
description: Number of subjects with no (none) irritant or allergic chip irritation. Chip irritation is assessed at all visits. Investigator makes overall determination on day 21.
arm group label: Positive reactions, Concordance with reference allergen
arm group type: Experimental
description: All subjects will be patch tested with 11 experimental and 11 reference allergens. Rates of positive reactions will be evaluated using Cohen's kappa calculation.
intervention type: Biological
intervention name: Metal Panel T.R.U.E. Test
description: Diagnostic patch test
arm group label: Positive reactions, Concordance with reference allergen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Curt Hamann, M.D.
role: Study Director
affiliation: Allerderm (dba SmartPractice)
last name: Kathryn Shannon
phone: 602-225-0595
email: kshannon@smarthealth.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
sharing ipd: No
ipd description: There is no plan to share individual participant data with other researchers.