Evaluation of vulvar leukoplakia photodynamic therapy efficiency by fluorescent diagnostics method with local «Alasens®» photosensitizer application

•Application of combined continuous-pulse irradiation mode for vulvar leukoplakia PDT was investigated for the first time in this study.•Clinical research results indicate strong potential in utilizing such technology towards treatment of pathological vulvar diseases.•The developed treatment protocol is profitable in terms of price and healing effect and allows carrying out theranostics daily in 20 patients.•Selectivity of PDT’ impact, absence of adverse reactions, and excellent cosmetic effect are the strengths of the applied approach. Using continuous-pulse irradiation mode application for performing photodynamic therapy sessions to introduce a new method, and conclude results of clinical research focused on vulvar leukoplakia photodynamic therapy efficiency in combination with topical aqueous «Alasens®» solution administration. Seventy patients (average age of 61 years) diagnosed with vulvar leukoplakia disease (2018 ICD-10-CM Diagnosis Code N90.4) were examined. The following values represent doses of combined mode photodynamic therapy session: 12 J/cm2 pulse radiation dose; 3.5 J/cm2 continuous radiation dose. Non-invasive spectroscopic and visual control of drug accumulation in real time was carried out by fluorescence diagnostic method before and after each therapy session. Single-therapy session efficiency was estimated by a fluorescent signal reduction in the pathological region after irradiation, and the direct correlation between photosensitizer photobleaching and disease regression was registered. Photodynamic therapy course included three procedures, with each session applied in 24 -h intervals, and when necessary, an additional course of therapy was applied 60 days afterward. Significant post-treatment results took effect after 2–3 courses with symptom presence reduced or fully regressed depending on the initial severity of the disease. Additionally, side effects and sequelae remained absent in all cases. The result of methods applied during the clinical research period indicate strong potential in utilizing such promising technology to contribute to the possible prevention of malignant transformation and the treatment of vulvar leukoplakia.