The efficacy of injecting hybrid cooperative complexes of hyaluronic acid for the treatment of vulvar lichen sclerosus: A preliminary study.

Lichen Sclerosus is a chronic-relapsing inflammatory skin disease usually involving the anogenital region lacking a resolutive therapy. Potent to high-potent topical corticosteroids are considered to be the standard first-line treatment. The objective of this preliminary study is to evaluate the efficacy of injecting Hybrid Cooperative Complexes of Hyaluronic Acid (HCC) in the treatment of Vulvar Lichen Sclerosus (VLS). Twenty-female patients (range 21-78 years) with histopathologic diagnosis of lichen sclerosus and good general conditions were enrolled. Patients underwent HCC infiltration every month, for three times. Patients had been assessed at baseline (T0) and after 1 and 6 months from treatment (T1 and T2, respectively). Clinical evaluation was executed in every visit. Itching, burning sensation, pain and dyspareunia were reported by a patient at T0, T1, and at T2. The effectiveness of the treatment on patients' quality life and sexual life was assessed using the Dermatology Life Quality Index (DLQI) at T0 and at T2. During or after the treatment no complications or side-effects were observed. All patients had a significant reduction in most symptoms after 1 and 6 months of HCC treatment. The reduction of patients with itching (p ≤ 0.001), pain (p = 0.031), burning sensation (p = 0.004) at 6 months is significant. The analysis of DLQI scores revealed a significant improvement in patients' quality of life. The DLQI mean score (±SD) at baseline and at follow-up was 5.89 ± 3.68 and 3.42 ± 2.36 (p = 0.002), respectively. Our preliminary study has demonstrated the safety and tolerability of HCC infiltrations in patients with VLS, and the effectiveness of HCC in reducing symptoms and, thus, to improve patient Quality of Life.