Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

January 5, 2017 updated by: BENI MOREINAS GRINBLAT, University of Sao Paulo General Hospital

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Recruiting
        • Hospital das Clínicas
        • Contact:
        • Contact:
        • Principal Investigator:
          • Beni Grinblat, md
        • Sub-Investigator:
          • Luis Torezan, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-multiple (at least five) actinic keratosis on the face, grades I and II

Exclusion Criteria:

  • phototypes IV, V and VI
  • patients treated for actinic keratosis up to 6 months before
  • history of allergy to methyl aminolevulinate
  • history of photoallergy
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Actinic Keratosis
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.
Drug: Methyl Aminolevulinate

Patients will be treated with Daylight Photodynamic therapy, following these steps:

  1. mild curettage of the AK lesions
  2. application of a chemical sunscreen SPF 30
  3. application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
  4. exposition to daylight, for 120 minutes
  5. cleaning of the face
Other Names:
  • Metvix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 3 months after treatment
Counting of Actinic keratosis
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological changes
Time Frame: 3 months after treatment
Histopathologic analysis in skin biopsies
3 months after treatment
immunochemistry changes
Time Frame: 3 months after treatment
immunochemistry analysis in skin biopsies
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Chair: Cyro Festa, md, Hospital das Clinicas da USP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 6, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.788.362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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