Efficacy of 5-aminolevulinic acid and LED laser photodynamic therapy in cervical intraepithelial neoplasia: a clinical trial

The incidence of HPV-related cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN) has not yet declined in Japan due to the suspension of HPV vaccines. While cervical conization is the standard treatment, photodynamic therapy is also an option. We present the first prospective clinical trial on topical 5-Aminolevulinic acid (5ALA) as a precursor photosensitizer and LED-based photodynamic therapy (PDT) for CIN, exploring an alternative outpatient treatment following the discontinuation of dye laser devices. Patients underwent two PDT sessions at one-week intervals during outpatient treatment, achieving favorable outcomes without photosensitivity or severe adverse events. Long-term follow-up showed positive effects in 96.1% of patients, with 70% achieving a complete response and a 79.4% HPV clearance rate in these patients. Five patients successfully gave birth after 5ALA-PDT. This study suggested that 5ALA-PDT using LED may provide a safe outpatient treatment for CIN.