Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Actinic Keratosis

Treatments: Drug: Methyl Aminolevulinate

Study type: Interventional

Funder types: Other

Identifiers

NCT03013647

1.788.362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Actinic Keratosis

Other group

Description:

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.

Treatment:

Drug: Methyl Aminolevulinate