Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment

NANot yet recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

November 30, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

May 30, 2026

Conditions
Actinic Keratoses
Interventions
PROCEDURE

light curettage

Before the treatment, the treated area will be degreased with 0.2% aqueous chlorhexidine. Next, a light curettage will be performed on the face with a sterile curette.

OTHER

Pre irradiation of 1 hour

A thin layer of the photosensitizing medication, approximately 1 mm thick, will be applied to the participant's facial lesion sites. Then an occlusive dressing will be used to enhance MAL penetration, which will be covered with aluminum foil to prevent ambient light from influencing the protoporphyrin production process. For the PDT technique, the dressing will remain on the face for 1 hour.

OTHER

Pre irradiation of 3 hour

A thin layer of the photosensitizing medication, approximately 1 mm thick, will be applied to the participant's facial lesion sites. Then an occlusive dressing will be used to enhance MAL penetration, which will be covered with aluminum foil to prevent ambient light from influencing the protoporphyrin production process. For the PDT technique, the dressing will remain on the face for 3 hour.

OTHER

topical application of 8% methyl aminolevulinate photosensitizer MAL

Participants will be treated with 8% topical MAL photosensitizer

OTHER

topical application of 16% methyl aminolevulinate photosensitizer (MAL)

Participants will be treated with 16% topical MAL photosensitizer

DEVICE

Visible light source

Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm

All Listed Sponsors
lead

University of Nove de Julho

OTHER

NCT06507644 - Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment | Biotech Hunter | Biotech Hunter