Actinic Keratosis Clinical Trial
Official title:
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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