The Efficacy of an Optimized, Low-Intensity Photodynamic Therapy Protocol with 10% 5-ALA Nanoemulsion in Refractory Vulvar Lichen Sclerosus: Impact on Quality of Life and Sexual Function.

Background: Treatment options for vulvar lichen sclerosus (VLS) remain limited; therefore, therapies that improve quality of life and reduce neoplastic risk are needed. Photodynamic therapy (PDT) is a potential option. This study aimed to evaluate quality of life and sexual function in patients treated according to the protocol used at our institution. Methods: Forty patients with refractory VLS underwent PDT using a 10% 5-aminolevulinic acid nanoemulsion (Ameluz®) applied to lesions under an occlusive aluminum foil dressing. Patients received 1-6 sessions of 10 min illumination (LED: 37 J/cm2, ~77 mW/cm2) at 4-6-week intervals. The Dermatology Life Quality Index (DLQI) and Female Sexual Function Index (FSFI) were used for assessment. Results: Thirty-seven participants answered DLQI, while 20 declared themselves to be sexually active and were included in the analysis. Greater number of PDT sessions was associated with a lower DLQI score (τ = -0.583; adjusted p < 0.001). The number of PDT sessions and the total FSFI score (p = 0.014), as well as desire (p = 0.016), arousal (p = 0.020), orgasm (p = 0.020), and satisfaction (p = 0.016) domains were significantly correlated. Age correlated positively with DLQI scores (p = 0.016), indicating greater disease burden in older patients. Longer disease duration was also associated with poorer quality of life (p = 0.020). Conclusions: PDT can be considered an effective treatment for patients with VLS refractory to standard topical corticosteroid and calcineurin inhibitor therapies when delivered using a refined, patient-centered protocol. This optimized approach used in our institution is based on short irradiation time and precise light delivery, providing a favorable balance between therapeutic efficacy, patient comfort, and treatment feasibility. Our findings also suggest that the cumulative number of PDT sessions is a key factor for clinical response. Further studies should address long-term outcomes.