Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
About this study
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.
- Condition
- Nodular Basal Cell Carcinoma of Skin
- Tested
- Control Arm (Conventional Therapy), Experimental arm
- Sponsor
- University of Sao Paulo
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 18 years
- Study condition: Nodular Basal Cell Carcinoma of Skin
- 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 8
- 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
1 site, 1 recruiting
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Contact
-
Ana G Salvio, Doctor
+55 (14) 3602-1374 gasalvio@hotmail.com
Potential match only. Final eligibility is determined by the study team.