Efficiency of Liposomal Gelcoat with Dihydroquercetin Flamena in Therapy of Vulvar Lichen Sclerosus

Abstract

Study Objective: To assess the therapeutic efficiency of liposomal gelcoat with dihydroquercetin Flamena in combination therapy of vulvar lichen sclerosus (VLS). Study Design: open comparative perspective study. Materials and Methods. The study included 52 patients with VLS aged 22 to 65 years. Patients were randomised into two therapeutic groups: 27 patients in group 1 had a standard course of therapy with ultrapotent topic glucocorticosteroids (tGCS) for 3 months; 25 patients in group 2 had a standard intermittent 3-month therapy with Flamena gel for 1.5 month. Therapy efficiency was evaluated using the Dermatological Symptom Scale, visual analogue scale, and Dermatological Quality of Life Index (DQoLI). Therapeutic manipulations were assessed during 6 visits. Study Results. Flamena gel facilitated clinical remission maintenance and prolongation. Starting from visit 4, there were differences between group 1 and group 2 values. By visit 5, group 2 patients demonstrated stable regression or reduction in white spots and papules/plaques (not more than 0.8 ± 0.35 and 0.5 ± 0.26 points, respectively). At the same time, group 1 had clinical symptoms intensity rising to 1.6 ± 0.87 points (white spots) and 1.2 ± 0.9 points (papules/plaques), correlating with subjective symptoms aggravation. Effects of therapy on DQoLI were demonstrated with reduction in mean values to 4.2 ± 2.6 points (group 1) and 3.2 ± 1.4 points (group 2) by visit 2. In group 2, the values remained at 3.3 ± 0.6 points by day 60 (visit 6) of follow-up, whereas in group 1 the VLS impact over quality of life increased from mild (4.2 ± 2.6 points — visit 2) to moderate (7.1 ± 2.3 points — visit 6) in a majority of study subjects. Conclusion. A comparative study demonstrated a marked therapeutic effect and high safety profile of Flamena gel in a combination therapy of VLS patients. It improves disease prognosis due to antiinflammatory, antiseptic and regenerative action, thus allowing reducing the frequency and amount of tGCS use. Keywords: vulvar lichen sclerosus, Flamena gel, vulvar itching