The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp. The main questions it aims to answer are:
Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy?
Does PDT with half-dose illumination protocol improve intervention tolerance?
Researchers will compare both treatment protocols using the patient as its own control.
Participants scalp will be divided in two halves, one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol, a skin biopsy will be obtained both pre and post-treatment of each of the areas. Variables will be assessed during the 3 visits of the study.
Patient with grade I and II actinic keratoses (AK) of Olsen on the scalp requiring field cancerization treatment.
≥ 18 years old.
More than 5 AK per field of cancerization to be treated.
More than 6 months since the last field treatment for AK performed.
Patients with photodermatoses.
Patients sensitive to methyl-aminolevulinate.
Patients with disabilities or unable to provide informed consent.
Patients who do not tolerate or do not wish to be treated with PDT.
Crossover
Half-dose illumination protocol
Other interventionArea will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J/cm2, with the illumination intensity being less than 200 mW/cm2.
Full-dose illumination protocol
Other interventionArea will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 37J/cm2, with the illumination intensity being less than 200 mW/cm2.
Response of 75% of the treated actinic keratosis at 3 months post-intervention.
Total count of actinic keratosis will be assessed
Tolerance during intervention
Pain assessed by Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst pain)
Histological grade of actinic keratosis in biopsies as well as relevant biomarkers
E-cadherin, MMPs, p53, UEA, HSP47 and CD117/c-kit presence on the tissue (from + to +++, depending on the intensity)
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This trial is not recruiting at the moment. You can still explore other options:
