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

PURPOSE: 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.

METHOD: 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.

RESULTS

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.

CONCLUSION

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.