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Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
Sponsor: University of Sao Paulo
Summary
Evaluation of a therapeutic protocol based on the combination of photodynamic therapy and sonodynamic therapy, referred to as sonophotodynamic therapy. Since this new protocol is applied in a single day, it is called the single-visit Sono-PDT protocol. This protocol will be used for the treatment of nodular basal cell carcinoma lesions.
Official title: Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2025-11-24
Completion Date
2026-12
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Control Arm (Conventional Therapy)
PDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Following the illumination procedure, the second session begins with a new application of MAL cream and an additional 1.5 hours of incubation. After this period, illumination is performed using the same light parameters as in the first session. After each MAL application, an occlusive dressing composed of PVC film, aluminum foil, gauze, and adhesive tape is applied to the lesion area to prevent light exposure and degradation of the produced PpIX.
Experimental arm
SonoPDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Immediately after illumination, the lesion will be irradiated with ultrasound (frequency: 1MHz, mode: pulsed, ultrasound intensity: 1.5 W/cm2, duty cycle: 50%, pulse frequency: 100 Hz) for 5 minutes. Following the sonication procedure, the second session begins with a new application of MAL cream with an incubation period of 1.5 hours. After this time, illumination and sonication are performed using the same excitation source parameters as in the first session.
Locations (1)
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil