<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/NCT03013647</url>
  </required_header>
  <id_info>
    <org_study_id>1.788.362</org_study_id>
    <nct_id>NCT03013647</nct_id>
  </id_info>
  <brief_title>Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization</brief_title>
  <official_title>Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and&#xD;
      will be treated with Daylight Photodynamic therapy.&#xD;
&#xD;
      Before and after skin biopsies will be performed, for histological and immunohistochemical&#xD;
      analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the&#xD;
      study. They will be informed of the procedure in detail and sign a consent form.&#xD;
&#xD;
      Digital photographs will be done in a standardized way. Prior to treatment, all patients will&#xD;
      undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will&#xD;
      be done over an AK lesion and the other in an area with no apparent AK (field cancerization).&#xD;
&#xD;
      The patients will be treated with Daylight Photodynamic Therapy, following these steps:&#xD;
&#xD;
        1. mild curettage of the AK lesions&#xD;
&#xD;
        2. application of a chemical sunscreen with sun protection factor (SPF) 30&#xD;
&#xD;
        3. application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)&#xD;
&#xD;
        4. exposition to daylight, for 120 minutes&#xD;
&#xD;
        5. cleaning of the face&#xD;
&#xD;
      Three months after treatment, two new skin biopsies will be collected, 1cm away from the&#xD;
      initial biopsies. On the same date, new photographs will be made following the same standards&#xD;
      as pre-treatment photographs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>N/A</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>Clinical improvement</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Counting of Actinic keratosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological changes</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Histopathologic analysis in skin biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>immunochemistry changes</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>immunochemistry analysis in skin biopsies</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Actinic Keratosis</condition>
  <arm_group>
    <arm_group_label>Actinic Keratosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methyl Aminolevulinate</intervention_name>
    <description>Patients will be treated with Daylight Photodynamic therapy, following these steps:&#xD;
mild curettage of the AK lesions&#xD;
application of a chemical sunscreen SPF 30&#xD;
application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)&#xD;
exposition to daylight, for 120 minutes&#xD;
cleaning of the face</description>
    <arm_group_label>Actinic Keratosis</arm_group_label>
    <other_name>Metvix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -multiple (at least five) actinic keratosis on the face, grades I and II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  phototypes IV, V and VI&#xD;
&#xD;
          -  patients treated for actinic keratosis up to 6 months before&#xD;
&#xD;
          -  history of allergy to methyl aminolevulinate&#xD;
&#xD;
          -  history of photoallergy&#xD;
&#xD;
          -  pregnancy&#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>Cyro Festa, md</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital das Clinicas da USP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Beni Grinblat, md</last_name>
    <phone>551138827070</phone>
    <email>bgrinblat@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luis Torezan, md</last_name>
    <email>torezanluis@uol.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clinicas</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beni Grinblat, md</last_name>
      <phone>551138827070</phone>
      <email>bgrinblat@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Luis torezan, md</last_name>
      <email>torezanluis@uol.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Beni Grinblat, md</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luis Torezan, md</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Fargnoli MC, Piccioni A, Neri L, Tambone S, Pellegrini C, Peris K. Long-term efficacy and safety of daylight photodynamic therapy with methyl amninolevulinate for actinic keratosis of the face and scalp. Eur J Dermatol. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available.</citation>
    <PMID>27748261</PMID>
  </reference>
  <reference>
    <citation>Grinblat B, Galimberti G, Pantoja G, Sanclemente G, Lopez M, Alcala D, Torezan L, Kerob D, Pascual T, Chouela E. Feasibility of daylight-mediated photodynamic therapy for actinic keratosis throughout the year in Central and South America: a meteorological study. Int J Dermatol. 2016 Sep;55(9):e488-93. doi: 10.1111/ijd.13256. Epub 2016 Apr 7.</citation>
    <PMID>27061814</PMID>
  </reference>
  <reference>
    <citation>Philipp-Dormston WG, Sanclemente G, Torezan L, Tretti Clementoni M, Le Pillouer-Prost A, Cartier H, Szeimies RM, Bjerring P. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15. doi: 10.1111/jdv.13327. Epub 2015 Nov 9.</citation>
    <PMID>26552049</PMID>
  </reference>
  <reference>
    <citation>Grinblat B, Galimberti G, Chouela E, Sanclemente G, Lopez M, Alcala D, Torezan L, Pantoja G. Daylight-mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Photodermatol Photoimmunol Photomed. 2016 Mar;32(2):81-7. doi: 10.1111/phpp.12221. Epub 2015 Dec 9.</citation>
    <PMID>26541910</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>BENI MOREINAS GRINBLAT</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>actinic keratosis</keyword>
  <keyword>field cancerization</keyword>
  <keyword>photodynamic therapy</keyword>
  <keyword>daylight 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>
    <mesh_term>Methyl 5-aminolevulinate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03013647
org study id: 1.788.362
nct id: NCT03013647
lead sponsor: 
has dmc: Yes
Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and
      will be treated with Daylight Photodynamic therapy.

      Before and after skin biopsies will be performed, for histological and immunohistochemical
      analysis.
Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the
      study. They will be informed of the procedure in detail and sign a consent form.

      Digital photographs will be done in a standardized way. Prior to treatment, all patients will
      undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will
      be done over an AK lesion and the other in an area with no apparent AK (field cancerization).

      The patients will be treated with Daylight Photodynamic Therapy, following these steps:

        1. mild curettage of the AK lesions

        2. application of a chemical sunscreen with sun protection factor (SPF) 30

        3. application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)

        4. exposition to daylight, for 120 minutes

        5. cleaning of the face

      Three months after treatment, two new skin biopsies will be collected, 1cm away from the
      initial biopsies. On the same date, new photographs will be made following the same standards
      as pre-treatment photographs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical improvement
time frame: 3 months after treatment
description: Counting of Actinic keratosis
measure: Histological changes
time frame: 3 months after treatment
description: Histopathologic analysis in skin biopsies
measure: immunochemistry changes
time frame: 3 months after treatment
description: immunochemistry analysis in skin biopsies
arm group label: Actinic Keratosis
arm group type: Other
description: Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area.
intervention type: Drug
intervention name: Methyl Aminolevulinate
description: Patients will be treated with Daylight Photodynamic therapy, following these steps:
mild curettage of the AK lesions
application of a chemical sunscreen SPF 30
application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
exposition to daylight, for 120 minutes
cleaning of the face
arm group label: Actinic Keratosis
other name: Metvix
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Cyro Festa, md
role: Study Chair
affiliation: Hospital das Clinicas da USP
last name: Beni Grinblat, md
phone: 551138827070
email: bgrinblat@gmail.com
last name: Luis Torezan, md
email: torezanluis@uol.com.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
citation: Fargnoli MC, Piccioni A, Neri L, Tambone S, Pellegrini C, Peris K. Long-term efficacy and safety of daylight photodynamic therapy with methyl amninolevulinate for actinic keratosis of the face and scalp. Eur J Dermatol. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available.
PMID: 27748261
citation: Grinblat B, Galimberti G, Pantoja G, Sanclemente G, Lopez M, Alcala D, Torezan L, Kerob D, Pascual T, Chouela E. Feasibility of daylight-mediated photodynamic therapy for actinic keratosis throughout the year in Central and South America: a meteorological study. Int J Dermatol. 2016 Sep;55(9):e488-93. doi: 10.1111/ijd.13256. Epub 2016 Apr 7.
PMID: 27061814
citation: Philipp-Dormston WG, Sanclemente G, Torezan L, Tretti Clementoni M, Le Pillouer-Prost A, Cartier H, Szeimies RM, Bjerring P. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15. doi: 10.1111/jdv.13327. Epub 2015 Nov 9.
PMID: 26552049
citation: Grinblat B, Galimberti G, Chouela E, Sanclemente G, Lopez M, Alcala D, Torezan L, Pantoja G. Daylight-mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Photodermatol Photoimmunol Photomed. 2016 Mar;32(2):81-7. doi: 10.1111/phpp.12221. Epub 2015 Dec 9.
PMID: 26541910
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: BENI MOREINAS GRINBLAT
investigator title: Principal Investigator
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Aminolevulinic Acid
mesh term: Methyl 5-aminolevulinate
sharing ipd: Yes