NCT07381972 Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
| NCT ID | NCT07381972 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Sao Paulo |
| Condition | Nodular Basal Cell Carcinoma of Skin |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 142 participants in total. It began in 2025-11-24 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nodular Basal Cell Carcinoma of Skin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07381972 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 142 participants.
Is NCT07381972 currently recruiting?
Yes, NCT07381972 is actively recruiting participants. Contact the research team at gasalvio@hotmail.com for enrollment information.
Where is the NCT07381972 trial being conducted?
This trial is being conducted at Jaú, Brazil.
Who is sponsoring the NCT07381972 clinical trial?
NCT07381972 is sponsored by University of Sao Paulo. The trial plans to enroll 142 participants.