Trial | NCT03013647  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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:

mild curettage of the AK lesions
application of a chemical sunscreen with sun protection factor (SPF) 30
application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
exposition to daylight, for 120 minutes
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 Started
Sep 30
2016
Primary Completion
Apr 30
2017
Anticipated
Study Completion
Jul 31
2017
Anticipated
Last Update
Jan 06
2017
Estimate

Drug Methyl Aminolevulinate

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

  • Other names: Metvix

Actinic Keratosis Other

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.

Criteria 

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
No Results Posted