Dermoscopy for Monitoring Therapeutic Response to Hybrid Cooperative Complexes of Hyaluronic Acid in Women with Vulvar Lichen Sclerosus and Atrophy

Giulio Rizzetto ¹ Edoardo De Simoni ¹ Alessandro Borghi ^2* Elisa Molinelli ¹ Marinella Tedesco ³ Emilia Migliano ³ Corrado Tagliati ¹ Monica Corazza ² Franco Grimolizzi ⁴ Gilberto Bellia ⁴ Camilla Barduagni ¹ Annamaria Offidani ¹ Oriana Simonetti ¹

• ¹ Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University,, Ancona, Italy
• ² Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Emilia-Romagna, Italy
• ³ Department of Plastic and Regenerative Surgery, San Gallicano Dermatological Institute IRCCS, Rome, Italy
• ⁴ IBSA Farmaceutici Itlay Srl, Lodi, Italy

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. 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. 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). These preliminary results add to the growing body of evidence highlighting the promising efficacy of HCC of HA for the treatment of VLS.