Overview
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.
Description
In the proposed treatment protocol, all the procedures of traditional PDT protocol will be maintained, with the addition of a dose of low-intensity therapeutic ultrasound immediately after the application of red light. Ultrasound, due to its greater ability to penetrate the skin, can help reach deeper tumor cells and thus improve treatment outcomes.
Eligibility
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.