xml: <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/NCT06027619</url>
    </required_header>
    <id_info>
      <org_study_id>CASE4623</org_study_id>
      <nct_id>NCT06027619</nct_id>
    </id_info>
    <brief_title>Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses</brief_title>
    <official_title>Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Biofrontera, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Case Comprehensive Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment&#xD;
        times will still be effective at treating actinic keratoses (AK) while reducing or&#xD;
        eliminating the pain that patients sometimes experience during conventional PDT treatment.&#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion,&#xD;
             still achieve significant inflammation and lesion clearance?&#xD;
  &#xD;
          -  Will shortened incubation times of Ameluz still achieve significant inflammation and&#xD;
             lesion clearance?&#xD;
  &#xD;
          -  Will the new test regimens achieve reduced pain during illumination?&#xD;
  &#xD;
          -  Will the new test regimens be safe?&#xD;
  &#xD;
        Participants will be randomly assigned to one of three treatment regimens, which will&#xD;
        determine the length of time that the topical medication will incubate on the face before red&#xD;
        light exposure in PDT treatments. The incubation period will be either 10 minutes, 20&#xD;
        minutes, or 60 minutes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment Efficacy based on Participant AK Lesion Clearance</measure>
      <time_frame>Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)</time_frame>
      <description>To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in Pain Level Reported Throughout Exposure to Red Light</measure>
      <time_frame>Pain measured during illumination with red light (during a 10 min period) at Visit 1 and at Visit 3</time_frame>
      <description>To demonstrate that a short-contact PDT protocol with Ameluz and red light generates less pain during illumination than the standard FDA-approved protocol currently used. Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS) at 1 min, 5 min, and 10 min.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Differences in Scores Reported on Patient Satisfaction Survey</measure>
      <time_frame>At month 6</time_frame>
      <description>To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will be better tolerated and provide higher patient satisfaction than the currently practiced protocol. Participant satisfaction will be measured by completing a Subject Satisfaction Questionnaire survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participant Reported Adverse Events and side effects</measure>
      <time_frame>At day 2-4 post-treatment</time_frame>
      <description>Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Actinic Keratosis</condition>
    <arm_group>
      <arm_group_label>Regimen A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Regimen B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Regimen C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topical aminolevulinate (10% ALA gel)</intervention_name>
      <description>10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period</description>
      <arm_group_label>Regimen A</arm_group_label>
      <arm_group_label>Regimen B</arm_group_label>
      <arm_group_label>Regimen C</arm_group_label>
      <other_name>Ameluz gel, 10% aminolevulinic acid</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Red light illumination</intervention_name>
      <description>Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2</description>
      <arm_group_label>Regimen A</arm_group_label>
      <arm_group_label>Regimen B</arm_group_label>
      <arm_group_label>Regimen C</arm_group_label>
      <other_name>BF-RhodoLED® Light Source</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Minimum of 10 actinic keratoses lesions on the face.&#xD;
  &#xD;
            -  Female subjects must not become pregnant during the study&#xD;
  &#xD;
            -  Subjects must be able to understand and willing to sign a written informed consent&#xD;
               document.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or nursing.&#xD;
  &#xD;
            -  Using any topical treatment on their AKs; must stop at least one month prior.&#xD;
  &#xD;
            -  Currently undergoing treatment for other cancers with medical or radiation therapy.&#xD;
  &#xD;
            -  Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of&#xD;
               the study material.&#xD;
  &#xD;
            -  Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Edward V Maytin, M.D. Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Edward V Maytin, M.D. Ph.D.</last_name>
      <phone>(216) 445-6676</phone>
      <email>maytine@ccf.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Actinic Keratoses</keyword>
    <keyword>Actinic Keratosis</keyword>
    <keyword>Photodynamic Therapy</keyword>
    <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>Aminolevulinic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data will be available 12/2024</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027619
  org study id: CASE4623
  nct id: NCT06027619
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: Yes
  The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment
        times will still be effective at treating actinic keratoses (AK) while reducing or
        eliminating the pain that patients sometimes experience during conventional PDT treatment.
        The main questions it aims to answer are:
  
          -  Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion,
             still achieve significant inflammation and lesion clearance?
  
          -  Will shortened incubation times of Ameluz still achieve significant inflammation and
             lesion clearance?
  
          -  Will the new test regimens achieve reduced pain during illumination?
  
          -  Will the new test regimens be safe?
  
        Participants will be randomly assigned to one of three treatment regimens, which will
        determine the length of time that the topical medication will incubate on the face before red
        light exposure in PDT treatments. The incubation period will be either 10 minutes, 20
        minutes, or 60 minutes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment Efficacy based on Participant AK Lesion Clearance
  time frame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
  description: To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
  measure: Differences in Pain Level Reported Throughout Exposure to Red Light
  time frame: Pain measured during illumination with red light (during a 10 min period) at Visit 1 and at Visit 3
  description: To demonstrate that a short-contact PDT protocol with Ameluz and red light generates less pain during illumination than the standard FDA-approved protocol currently used. Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS) at 1 min, 5 min, and 10 min.
  measure: Differences in Scores Reported on Patient Satisfaction Survey
  time frame: At month 6
  description: To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will be better tolerated and provide higher patient satisfaction than the currently practiced protocol. Participant satisfaction will be measured by completing a Subject Satisfaction Questionnaire survey.
  measure: Number of Participant Reported Adverse Events and side effects
  time frame: At day 2-4 post-treatment
  description: Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.
  arm group label: Regimen A
  arm group type: Experimental
  description: Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source
  arm group label: Regimen B
  arm group type: Experimental
  description: Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source
  arm group label: Regimen C
  arm group type: Experimental
  description: Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source
  intervention type: Drug
  intervention name: Topical aminolevulinate (10% ALA gel)
  description: 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period
  arm group label: Regimen A
  arm group label: Regimen B
  arm group label: Regimen C
  other name: Ameluz gel, 10% aminolevulinic acid
  intervention type: Device
  intervention name: Red light illumination
  description: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
  arm group label: Regimen A
  arm group label: Regimen B
  arm group label: Regimen C
  other name: BF-RhodoLED® Light Source
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Edward V Maytin, M.D. Ph.D.
  role: Principal Investigator
  affiliation: Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
  last name: Edward V Maytin, M.D. Ph.D.
  phone: (216) 445-6676
  email: maytine@ccf.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Keratosis
  mesh term: Aminolevulinic Acid
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data will be available 12/2024