<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/NCT03279328</url>
  </required_header>
  <id_info>
    <org_study_id>1708724736</org_study_id>
    <nct_id>NCT03279328</nct_id>
  </id_info>
  <brief_title>Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents</brief_title>
  <official_title>Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposed project will be an open-label, split face, randomized controlled pilot study.&#xD;
      Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The&#xD;
      purpose of this study is to understand the change in skin appearance throughout 5-FU&#xD;
      treatment course and to examine whether a topical corticosteroid and moisturizer can decrease&#xD;
      severity and duration of skin inflammation after 5-FU treatment course.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study to understand the change in skin appearance during and after the&#xD;
      course of 5-FU cream in patients with AK, and compare how the appearance of skin inflammation&#xD;
      changes with the use of topical corticosteroids and moisturizers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin barrier biophysical properties</measure>
    <time_frame>2 hours</time_frame>
    <description>Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Actinic Keratoses</condition>
  <arm_group>
    <arm_group_label>Topical Steroid Ointment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One side of the face will receive a Topical Steroid ointment twice daily for seven days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaseline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One side of the face will receive Vaseline twice daily for seven days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skin Barrier Moisturizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Steroid Ointment</intervention_name>
    <description>Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.</description>
    <arm_group_label>Topical Steroid Ointment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vaseline</intervention_name>
    <description>Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.</description>
    <arm_group_label>Vaseline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Skin Barrier Moisturier</intervention_name>
    <description>Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.</description>
    <arm_group_label>Skin Barrier Moisturizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female, at least 18 years of age&#xD;
&#xD;
          -  Subject must have a diagnosis of actinic keratosis (at least 5 lesions on each side of&#xD;
             the face)&#xD;
&#xD;
          -  Able to comprehend and read the English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not fit the inclusion criteria&#xD;
&#xD;
          -  Concurrently have other inflammatory skin conditions.&#xD;
&#xD;
          -  Prior known allergy to any components to of 5FU cream, topical steroid ointment or&#xD;
             vaseline.&#xD;
&#xD;
             • Subject who, in the opinion of the investigator, will be uncooperative or unable to&#xD;
             comply with study procedures (i.e.: compliant with using 5-FU cream, topical&#xD;
             corticosteroid or moisturizers&#xD;
&#xD;
          -  Those that are prisoners or cognitively impaired.&#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>University of Arizona - Banner University Medicine Dermatology</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 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>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Petrolatum</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 1, 2021</submitted>
    <returned>June 23, 2021</returned>
  </pending_results>
  <!-- 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/NCT03279328
org study id: 1708724736
nct id: NCT03279328
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This proposed project will be an open-label, split face, randomized controlled pilot study.
      Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The
      purpose of this study is to understand the change in skin appearance throughout 5-FU
      treatment course and to examine whether a topical corticosteroid and moisturizer can decrease
      severity and duration of skin inflammation after 5-FU treatment course.
The purpose of this study to understand the change in skin appearance during and after the
      course of 5-FU cream in patients with AK, and compare how the appearance of skin inflammation
      changes with the use of topical corticosteroids and moisturizers.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Skin barrier biophysical properties
time frame: 2 hours
description: Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)
arm group label: Topical Steroid Ointment
arm group type: Active Comparator
description: One side of the face will receive a Topical Steroid ointment twice daily for seven days.
arm group label: Vaseline
arm group type: Active Comparator
description: One side of the face will receive Vaseline twice daily for seven days.
arm group label: Skin Barrier Moisturizer
arm group type: Active Comparator
description: One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
intervention type: Drug
intervention name: Topical Steroid Ointment
description: Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
arm group label: Topical Steroid Ointment
intervention type: Other
intervention name: Vaseline
description: Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
arm group label: Vaseline
intervention type: Drug
intervention name: Skin Barrier Moisturier
description: Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
arm group label: Skin Barrier Moisturizer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Petrolatum
sharing ipd: No
submitted: June 1, 2021
returned: June 23, 2021