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

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Sao Paulo
NCT07381972 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Control Arm (Conventional Therapy)
  • Experimental arm
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Where

1 site
Hospital Amaral Carvalho
Jaú, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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