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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03013647

Enrollment

Registered

2017-01-06

Start date

2016-09-30

Completion date

2017-07-31

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

actinic keratosis, field cancerization, photodynamic therapy, daylight photodynamic therapy

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: 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.

Interventions

DRUGMethyl 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical improvement	3 months after treatment	Counting of Actinic keratosis

Secondary

Measure	Time frame	Description
Histological changes	3 months after treatment	Histopathologic analysis in skin biopsies
immunochemistry changes	3 months after treatment	immunochemistry analysis in skin biopsies

Countries

Brazil

Contacts

Primary ContactBeni Grinblat, md

bgrinblat@gmail.com551138827070

Backup ContactLuis Torezan, md

torezanluis@uol.com.br

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026