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

Recruiting now · Phase 3

Conditions studied: Nodular Basal Cell Carcinoma of Skin

In brief

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.

Key facts

Study ID: NCT07381972
Run by: University of Sao Paulo
People needed: 142
Starts: 2025-11-24
Expected to finish: 2026-12-01
Last updated by the study team: 2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Hospital Amaral Carvalho — Jaú, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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