Abstract
INTRODUCTION: Vulvar Lichen Sclerosus (VLS) is a chronic relapsing inflammatory disease involving the anogenital region, resulting in vulvar atrophy and distressing symptoms. A preliminary prospective observational study was conducted to investigate the efficacy of hybrid cooperative complexes (HCC) of low- and high-molecular weight hyaluronic acid (HA) for the treatment of female patients with vulvar atrophy and lichen sclerosus. METHODS: Female patients with coexisting vulvar atrophy and lichen sclerosus (N=15) received two HCC injections at 32 mg/ml (one month apart). At baseline, 1-month, 3-months, and 6-months post-treatment, patients were assessed for reference dermatoscopic parameters using videodermatoscopy, symptoms, quality of life (Dermatology Life Quality Index [DLQI]) and sexual function (Female Sexual Function Index [FSFI]). The hypoechoic band was evaluated using ultrasound. RESULTS: Both DLQI and FSFI scores improved with HCC treatment, with significant improvements at 1-month, 3-months and 6-months post-treatment vs baseline (p<0.05 for all). The thickness, homogeneity and smoothness of the hypoechoic band increased post-treatment. No side effects or complications were reported. The reference dermatoscopic features of vascularisation, blue grey dots, purpuric lesions, horny pearls, scales, ice silvers structures or whitish background were reduced at 6-months post-treatment vs baseline; significant reductions were observed for scales (baseline vs 1-month and 6-months post-treatment; p<0.05 for both). Scores for pain, itching, and burning were reduced at 1-month, 3-months and 6-months post-treatment vs baseline (p<0.05 for all). DISCUSSION: These preliminary results add to the growing body of evidence highlighting the promising efficacy of HCC of HA for the treatment of VLS.