Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Study Overview
=================
Brief 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: 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.

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

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Methyl Aminolevulinate


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Actinic Keratosis<br>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<br>* 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<br>* Other names: Metvix;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
actinic keratosis, field cancerization, photodynamic therapy, daylight photodynamic therapy