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

University of Sao Paulo

Status and phase: Enrolling; Phase 3

Conditions: Nodular Basal Cell Carcinoma of Skin

Treatments: Combination Product: Experimental arm; Combination Product: Control Arm (Conventional Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07381972

U1111-1330-4954 (Other Identifier)

7.810.244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Photodynamic therapy (PDT) protocol

Active Comparator group

Description:

In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion.

Treatment:

Combination Product: Control Arm (Conventional Therapy)

Sono-Photodynamic Therapy (SonoPDT) protocol

Experimental group

Description:

In this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol.

Treatment:

Combination Product: Experimental arm