<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/NCT03783988</url>
  </required_header>
  <id_info>
    <org_study_id>TRO-SA01</org_study_id>
    <nct_id>NCT03783988</nct_id>
  </id_info>
  <brief_title>Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids</brief_title>
  <official_title>An Open, Uncontrolled Pharmacokinetic Study With a New Topical Combination Gel Containing Triiodothyroacetic Acid (TRIAC) and Dehydroepiandrosterone (DHEA) in Subjects With Skin Atrophy Due to Topical Treatment With Glucocorticoids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trophea Development AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Trophea Development AB</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>
      An open, uncontrolled pharmacokinetic study with a new topical combination gel containing&#xD;
      triiodothyroacetic acid (TRIAC) and dehydroepiandrosterone (DHEA) in subjects with skin&#xD;
      atrophy due to topical treatment with glucocorticoids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the Baseline Visit (Day 1) and after completion of all evaluations, each subject who&#xD;
      qualifies for entry will will receive a dose of 0.5 g IMP on the back of a hand affected with&#xD;
      skin atrophy.&#xD;
&#xD;
      PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2019</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>Phase 1</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>This is a pharmacokinetic study to study the systemic levels of DHEA, DHEAs and TRIAC, before and after application of a new topical combination gel containing DHEA and TRIAC. MS-based validated methods will be used.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.</measure>
    <time_frame>0-72 hours</time_frame>
    <description>MS-based method for analysis of DHEA will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.</measure>
    <time_frame>0-72 hours</time_frame>
    <description>MS-based method for analysis of TRIAC will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.</measure>
    <time_frame>0-72 hours</time_frame>
    <description>MS-based method for analysis of DHEA-S will be used.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Skin Atrophy</condition>
  <arm_group>
    <arm_group_label>Open uncontrolled pharmacokinetic study</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>DHEA and TRIAC</intervention_name>
    <description>The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)</description>
    <arm_group_label>Open uncontrolled pharmacokinetic study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent has been obtained prior to initiating any study specific&#xD;
             procedures&#xD;
&#xD;
          2. Men and women of at least 18 years old&#xD;
&#xD;
          3. Subjects with hand eczema and confirmed skin atrophy on the back of a hand caused by&#xD;
             treatment with topical glucocorticoids for at least 6 months&#xD;
&#xD;
          4. Atrophic skin area of approximately 100 cm2 (back of a hand)&#xD;
&#xD;
          5. Females of childbearing potential must have a negative urine pregnancy test result&#xD;
             upon entry into the study&#xD;
&#xD;
          6. Females of child-bearing potential may participate only if using reliable means of&#xD;
             contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Skin atrophy with open ulcer(s) involved&#xD;
&#xD;
          2. Participation in any other study involving investigational drug(s) within 30 days&#xD;
             prior to study entry&#xD;
&#xD;
          3. Use of systemic or topical glucocorticoids, thyroid hormones, vitamin A analogues,&#xD;
             DHEA, and testosterone within 3 weeks before entry into the study&#xD;
&#xD;
          4. Known thyroid disease of any type&#xD;
&#xD;
          5. Women with polycystic ovary syndrome (PCO), congenital adrenal hyperplasia or other&#xD;
             androgen excess syndromes&#xD;
&#xD;
          6. Subjects who have previously participated in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Roskilde University Hospital, Dept of Dermatology</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <contact>
      <last_name>Gregor Jemec, MD, Prof.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</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>Atrophy</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/NCT03783988
org study id: TRO-SA01
nct id: NCT03783988
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An open, uncontrolled pharmacokinetic study with a new topical combination gel containing
      triiodothyroacetic acid (TRIAC) and dehydroepiandrosterone (DHEA) in subjects with skin
      atrophy due to topical treatment with glucocorticoids.
At the Baseline Visit (Day 1) and after completion of all evaluations, each subject who
      qualifies for entry will will receive a dose of 0.5 g IMP on the back of a hand affected with
      skin atrophy.

      PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a pharmacokinetic study to study the systemic levels of DHEA, DHEAs and TRIAC, before and after application of a new topical combination gel containing DHEA and TRIAC. MS-based validated methods will be used.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in systemic levels (ng/ml) of DHEA after a single topical administration, from baseline (hours) to 72 hours.
time frame: 0-72 hours
description: MS-based method for analysis of DHEA will be used.
measure: Change in systemic levels (ng/ml) of TRIAC after a single topical administration, from baseline (hours) to 72 hours.
time frame: 0-72 hours
description: MS-based method for analysis of TRIAC will be used.
measure: Change in systemic levels (ng/ml) of DHEA-S after a single topical administration, from baseline (hours) to 72 hours.
time frame: 0-72 hours
description: MS-based method for analysis of DHEA-S will be used.
arm group label: Open uncontrolled pharmacokinetic study
arm group type: Other
description: Single armed - All subjects receive one dose of topical combination gel containing TRIAC and DHEA
intervention type: Combination Product
intervention name: DHEA and TRIAC
description: The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
arm group label: Open uncontrolled pharmacokinetic study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Atrophy
sharing ipd: No