<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/NCT03279744</url>
  </required_header>
  <id_info>
    <org_study_id>IRC241001</org_study_id>
    <nct_id>NCT03279744</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion</brief_title>
  <official_title>A Prospective, Single-Arm, Open-Label, Phase II. Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-Pdt in Patients With Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharma Power Biotec Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pharma Power Biotec Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of&#xD;
      Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral&#xD;
      Verrucous Hyperplasia or Oral Erythroleukoplakia).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of&#xD;
      topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral&#xD;
      erythroleukoplakia (OEL).&#xD;
&#xD;
      Total duration of the study will be up to 40 weeks (from screening throughout study until&#xD;
      completion) as follows:&#xD;
&#xD;
        -  Screening (within 2 weeks before dosing)&#xD;
&#xD;
        -  Treatment period (up to 14 weeks)&#xD;
&#xD;
        -  Safety follow-up period (within 2 weeks after final treatment)&#xD;
&#xD;
        -  Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks&#xD;
           respectively) All enrolled patients will receive up to 8 treatments (once every two&#xD;
           weeks) during a maximum of 14-week study treatment period. The treated lesion will be&#xD;
           clinically evaluated and documented (clinical photograph) at each treatment visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 4, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total</measure>
    <time_frame>2-week safety follow-up period after last treatment</time_frame>
    <description>The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total.&#xD;
Complete response (CR): lack of detectable lesion confirmed by visual evaluation.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Erythroleukoplakia of Mouth</condition>
  <condition>Verrucous Hyperplasia of Oral Mucosa</condition>
  <arm_group>
    <arm_group_label>Single-Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radion™-pdt</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Radion™-pdt</intervention_name>
    <description>The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm^2 and properly cover the entire lesion.</description>
    <arm_group_label>Single-Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged ≥20 years old;&#xD;
&#xD;
          2. Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions&#xD;
             with histological evidence of oral precancerous lesions. Besides, patients should have&#xD;
             at least one lesion whose size should not exceed 4 cm in the greatest diameter and the&#xD;
             distance between two lesions should not less than 1 cm.&#xD;
&#xD;
          3. Patient who is willing and able to comply with study procedures and sign informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with history of hypersensitivity to any photosensitizer (including&#xD;
             5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;&#xD;
&#xD;
          2. Record of previous unsuccessful treatment with photodynamic therapy;&#xD;
&#xD;
          3. Patients who have been diagnosed as having oral cancer or carcinoma in situ;&#xD;
&#xD;
          4. Patients who have a history or evidence of a medical condition that would expose them&#xD;
             to an undue risk of a significant adverse event during the course of the trial,&#xD;
             including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine,&#xD;
             immune, neurological, hematological, gastrointestinal or psychiatric disease as&#xD;
             determined by the clinical judgment of the investigator;&#xD;
&#xD;
          5. Patients with impaired hepatic function (defined as AST and/or ALT &gt; 2× the upper&#xD;
             limit of normal values), and/or impaired renal function (defined as serum creatinine &gt;&#xD;
             1.5 mg/dL);&#xD;
&#xD;
          6. Female patient of childbearing potential who:&#xD;
&#xD;
               -  is lactating; or&#xD;
&#xD;
               -  has positive urine pregnancy test at visit -1; or&#xD;
&#xD;
               -  refuses to adopt reliable method of contraception during the study;&#xD;
&#xD;
          7. Patient has received any other investigational agent within 28 days or 5 half-lives,&#xD;
             whichever is longer, prior to the first photodynamic therapy;&#xD;
&#xD;
          8. Patient has a history of illegal substance abuse, drug addiction or alcoholism within&#xD;
             24 weeks prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Ming Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Zhongzheng Dist</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>December 30, 2019</last_update_submitted>
  <last_update_submitted_qc>December 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Verrucous Hyperplasia</keyword>
  <keyword>Oral Erythroleukoplakia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperplasia</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/NCT03279744
org study id: IRC241001
nct id: NCT03279744
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of
      Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral
      Verrucous Hyperplasia or Oral Erythroleukoplakia).
This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of
      topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral
      erythroleukoplakia (OEL).

      Total duration of the study will be up to 40 weeks (from screening throughout study until
      completion) as follows:

        -  Screening (within 2 weeks before dosing)

        -  Treatment period (up to 14 weeks)

        -  Safety follow-up period (within 2 weeks after final treatment)

        -  Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks
           respectively) All enrolled patients will receive up to 8 treatments (once every two
           weeks) during a maximum of 14-week study treatment period. The treated lesion will be
           clinically evaluated and documented (clinical photograph) at each treatment visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total
time frame: 2-week safety follow-up period after last treatment
description: The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total.
Complete response (CR): lack of detectable lesion confirmed by visual evaluation.
arm group label: Single-Arm
arm group type: Experimental
description: Radion™-pdt
intervention type: Drug
intervention name: Radion™-pdt
description: The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm^2 and properly cover the entire lesion.
arm group label: Single-Arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hsin-Ming Chen
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hyperplasia