Salvio Ana Gabriela, Requena Michelle Barreto, Stringasci Mirian Denise, Silva Ana Paula, Buzza Hilde Barb, Veneziano Donaldo Botelho, Oliveira Elisangela Ramos, Medero Maira Monique, Inada Natalia Mayumi, Kurachi Cristina, Moriyama Lilian Tan, Nogueira Marcelo Saito, Angarita Dora Patricia Ramirez, Volet-Filho Dirceu, Bagnato Vanderlei Salvador
Skin Department of Amaral Carvalho Hospital, Jahu, SP, Brazil.
Sao Carlos Institute of Physics, University of Sao Paulo (USP), São Carlos, SP, Brazil.
Photodiagnosis Photodyn Ther. 2025 Aug;54:104702. doi: 10.1016/j.pdpdt.2025.104702. Epub 2025 Jul 3.
Topical Photodynamic Therapy (PDT) is a well-studied and effective treatment for basal cell carcinoma (BCC) and pre-malignant lesions. Developing a cheaper approach to this treatment involves local production of aminolevulinic acid (ALA) and methyl aminolevulinate (MAL). Furthermore, a prospective study to verify its clinical effectiveness and advantages was required.
This randomized, controlled trial evaluated the efficacy of MAL-PDT and ALA-PDT treatments for BCC using photosensitizers produced in Brazil, and compared with surgical treatment as a third arm, all with long-term follow-up.
567 patients with small nodular BCCs were randomized for ALA-PDT, MALPDT, or surgical treatment. Both PDT groups had a 30-day post-treatment biopsy for cure rate assessment, and a clinical 10 years-follow-up was performed.
The 30-day post-treatment biopsy showed a complete response of 90.4 % for ALA-PDT (171/189 patients) and 86.1 % for MAL-PDT (161/187), while surgery showed free margins in 97.2 % (177/182). Considering 5 and 10 years of follow-up, 93.7 % and 92.8 % of recurrence-free survival rate for surgery, respectively, while 78.6 % and 74.5 % for ALA-PDT, and 73.1 % and 69 % for MAL-PDT were observed.
Surgery remains the gold standard treatment for nodular BCC; however, if non-surgical treatment is chosen, both ALA-PDT and MAL-PDT achieve similar effectiveness and recurrence-free survival rates. While surgery has already yielded optimal results, PDT still has room for great improvement as discussed here.
