Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
Recruiting
Phase 3Interventional Study
Nodular Basal Cell Carcinoma of Skin
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
142 (estimated)
Sponsor
University of Sao Paulo · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 ba…
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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