<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/NCT02978209</url>
  </required_header>
  <id_info>
    <org_study_id>UFKOPAUH201601</org_study_id>
    <nct_id>NCT02978209</nct_id>
  </id_info>
  <brief_title>Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris</brief_title>
  <acronym>Urea-IV</acronym>
  <official_title>Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      A randomized double blinded clinical trial will be conducted comparing the effect of two&#xD;
      simple basic moisturizers only different in the concentration of carbamide (urea). The&#xD;
      concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be&#xD;
      conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 %&#xD;
      carbamide, respectively. Approximately 20 patients with at least clinically verified&#xD;
      Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will&#xD;
      be assessed by clinical examination (score), patients assesment of effect and measurement of&#xD;
      transepidermal water loss (TEWL) and other skin parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">November 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin dryness</measure>
    <time_frame>2-8 weeks</time_frame>
    <description>Transepidermal water loss ('TEWL) (g/m2/h)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Ichthyosis Vulgaris</condition>
  <arm_group>
    <arm_group_label>Only moisturizer, no carbamide</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moisturizer + 7,5 % carbamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>7.5 %</intervention_name>
    <description>Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 0 % on one half of the body twice a day while applying the same moisturizer with 7.5 % urea on the other half of the body in the same quantity at the same frequence</description>
    <arm_group_label>Moisturizer + 7,5 % carbamide</arm_group_label>
    <other_name>Carbamide = Urea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed with Ichthyosis Vulgaris&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All other forms of Ichthyosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uffe Koppelhus, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate professsor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>DK-8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 29, 2019</last_update_submitted>
  <last_update_submitted_qc>October 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 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>Ichthyosis</mesh_term>
    <mesh_term>Ichthyosis, Lamellar</mesh_term>
    <mesh_term>Ichthyosis Vulgaris</mesh_term>
  </condition_browse>
  <!-- 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/NCT02978209
org study id: UFKOPAUH201601
nct id: NCT02978209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized double blinded clinical trial will be conducted comparing the effect of two
      simple basic moisturizers only different in the concentration of carbamide (urea). The
      concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be
      conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 %
      carbamide, respectively. Approximately 20 patients with at least clinically verified
      Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will
      be assessed by clinical examination (score), patients assesment of effect and measurement of
      transepidermal water loss (TEWL) and other skin parameters.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Skin dryness
time frame: 2-8 weeks
description: Transepidermal water loss ('TEWL) (g/m2/h)
arm group label: Only moisturizer, no carbamide
arm group type: No Intervention
description: 20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
arm group label: Moisturizer + 7,5 % carbamide
arm group type: Active Comparator
description: 20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half
intervention type: Device
intervention name: 7.5 %
description: Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 0 % on one half of the body twice a day while applying the same moisturizer with 7.5 % urea on the other half of the body in the same quantity at the same frequence
arm group label: Moisturizer + 7,5 % carbamide
other name: Carbamide = Urea
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Uffe Koppelhus, MD, PhD
role: Principal Investigator
affiliation: Associate professsor
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Ichthyosis
mesh term: Ichthyosis, Lamellar
mesh term: Ichthyosis Vulgaris