RecruitingPhase 3NCT07381972

Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

Sponsor

University of Sao Paulo

Enrollment

142 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

Nodular Basal Cell Carcinoma of Skin

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two light-based skin treatments — photodynamic therapy (light-activated cream) and sonodynamic therapy (sound waves) — for a common type of skin cancer called nodular basal cell carcinoma. The goal is to see if using both treatments together works better than either one alone. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with nodular basal cell carcinoma confirmed by biopsy - Your skin lesion is 1.0 cm or smaller in diameter - You have multiple lesions, as long as each one meets the study criteria **You may NOT be eligible if...** - Your lesion is larger than 1.0 cm - You have an aggressive subtype of basal cell carcinoma (infiltrative, sclerodermiform/morpheaform, or similar) - You are allergic to the study cream (methyl aminolevulinate) - You have a condition called porphyria or another disorder affecting how your body processes certain compounds - You are pregnant, breastfeeding, or not using contraception - You have a photosensitive disease such as lupus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTControl 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.

COMBINATION_PRODUCTExperimental 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

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NCT07381972