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

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

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.

Conditions2

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