NCT03013647

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-04-01
• Completion: 2017-07-01
• First posted: 2017-01-06
• Last updated: 2017-01-06

Locations

1 site across 1 country: Brazil