RECRUITINGPhase 3INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults of both sexes, aged 18 years and older. - diagnosed by tissue sample (biopsy-confirmed) nodular basal cell carcinoma with lesion diameter ≤1.0 cm. - Participants with multiple lesions may be included, provided that each lesion meets all inclusion criteria. Who Should NOT Join This Trial: - Nodular basal cell carcinoma lesions \>1.0 cm in diameter. - Known hypersensitivity or allergy to methyl aminolevulinate (MAL) or any excipients of the study medication. - Histological subtypes of infiltrative basal cell carcinoma, including micronodular, infiltrative, sclerodermiform (morpheaform), plano-cicatricial, or terebrant subtypes. - Porphyria or other disorders of porphyrin metabolism. - Pregnant or breastfeeding women. - Women of childbearing potential not using an acceptable method of contraception. - Presence of photosensitive diseases, including lupus erythematosus. - Any condition that, in the investigator's opinion, would interfere with study participation or safety. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Adults of both sexes, aged 18 years and older. * Histologically confirmed nodular basal cell carcinoma with lesion diameter ≤1.0 cm. * Participants with multiple lesions may be included, provided that each lesion meets all inclusion criteria. Exclusion Criteria: * Nodular basal cell carcinoma lesions \>1.0 cm in diameter. * Known hypersensitivity or allergy to methyl aminolevulinate (MAL) or any excipients of the study medication. * Histological subtypes of infiltrative basal cell carcinoma, including micronodular, infiltrative, sclerodermiform (morpheaform), plano-cicatricial, or terebrant subtypes. * Porphyria or other disorders of porphyrin metabolism. * Pregnant or breastfeeding women. * Women of childbearing potential not using an acceptable method of contraception. * Presence of photosensitive diseases, including lupus erythematosus. * Any condition that, in the investigator's opinion, would interfere with study participation or safety.

Treatments Being Tested

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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