<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/NCT04429308</url>
  </required_header>
  <id_info>
    <org_study_id>STU00211723</org_study_id>
    <nct_id>NCT04429308</nct_id>
  </id_info>
  <brief_title>PDT vs Peels for AKs</brief_title>
  <official_title>PDT Versus the Combination of Jessner's Solution and 35% TCA for Treatment of Actinic Keratoses on Upper Extremities: A Randomized Controlled Split-arm Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination&#xD;
      of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of&#xD;
      actinic keratoses on upper extremities.&#xD;
&#xD;
      This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on&#xD;
      both upper arms will be randomized to have one arm receive photodynamic therapy, while the&#xD;
      contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be&#xD;
      counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed&#xD;
      to determine the feasibility of this procedure.&#xD;
&#xD;
      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion&#xD;
      criteria will be considered for enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of total AKs cleared</measure>
    <time_frame>2-8 weeks after treatments</time_frame>
    <description>Percentage of total AKs cleared will be calculated by counting the number of AKs before treatment and 2-8 weeks after treatments.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Actinic Keratoses</condition>
  <arm_group>
    <arm_group_label>Photodynamic Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One upper arm will be exposed to blue light therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemical Peels</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Photodynamic Therapy</intervention_name>
    <description>Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)</description>
    <arm_group_label>Photodynamic Therapy</arm_group_label>
    <other_name>PDT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemical Peels</intervention_name>
    <description>Chemical peels consists of a combination of Jessner's Solution: Composed of Salicylic Acid (14%), Medical Grade Lactic Acid (14%), Medical Grade Resorcinol (14%), Denatured Ethyl Alcohol AND 35% Trichloroacetic acid peels</description>
    <arm_group_label>Chemical Peels</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years of age&#xD;
&#xD;
          2. Interested in receiving treatment for actinic keratoses on the bilateral upper arms&#xD;
&#xD;
          3. In good general health as assessed by the investigator&#xD;
&#xD;
          4. Participants must have the ability to understand and the willingness to sign a written&#xD;
             informed consent prior to registration on study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient pregnant or nursing&#xD;
&#xD;
          2. Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on&#xD;
             upper extremities that would interfere with treatment as determined by the treating&#xD;
             physician&#xD;
&#xD;
          3. Subject unwilling to sign an IRB approved consent form&#xD;
&#xD;
          4. Participants who are unable to communicate or cooperate with the investigator due to&#xD;
             language problems, poor mental development, or impaired cerebral function are not&#xD;
             eligible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alejandra Onate, M.S.</last_name>
    <email>onate@northwestern.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Northwestern University Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Murad Alam, MD</last_name>
      <phone>312-695-6785</phone>
      <email>m-alam@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Murad Alam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor of Dermatology</investigator_title>
  </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>
  <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/NCT04429308
org study id: STU00211723
nct id: NCT04429308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination
      of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of
      actinic keratoses on upper extremities.

      This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on
      both upper arms will be randomized to have one arm receive photodynamic therapy, while the
      contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be
      counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed
      to determine the feasibility of this procedure.

      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion
      criteria will be considered for enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of total AKs cleared
time frame: 2-8 weeks after treatments
description: Percentage of total AKs cleared will be calculated by counting the number of AKs before treatment and 2-8 weeks after treatments.
arm group label: Photodynamic Therapy
arm group type: Active Comparator
description: One upper arm will be exposed to blue light therapy
arm group label: Chemical Peels
arm group type: Active Comparator
description: One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel
intervention type: Procedure
intervention name: Photodynamic Therapy
description: Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)
arm group label: Photodynamic Therapy
other name: PDT
intervention type: Drug
intervention name: Chemical Peels
description: Chemical peels consists of a combination of Jessner's Solution: Composed of Salicylic Acid (14%), Medical Grade Lactic Acid (14%), Medical Grade Resorcinol (14%), Denatured Ethyl Alcohol AND 35% Trichloroacetic acid peels
arm group label: Chemical Peels
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
last name: Alejandra Onate, M.S.
email: onate@northwestern.edu
facility: 
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor of Dermatology
mesh term: Keratosis, Actinic
mesh term: Keratosis
sharing ipd: No