Aesthetic Surgery Journal, vol.45, no.11, pp.1166-1174, 2025 (SCI-Expanded, Scopus)
Background: Vulvar lichen sclerosus (VLS) is a chronic inflammatory dermatosis that impairs the quality of life through symptoms such as itching, pain, and atrophy, and has limited response to conventional corticosteroid therapy. Objectives: The authors of this study aim to evaluate the safety and efficacy of the Lichen-SVF protocol, a regenerative treatment combining nanofat and mechanically isolated stromal vascular fraction (SVF) for moderate-to-severe VLS. Methods: In this prospective, open-label study, the authors included 18 women with moderate-to-severe VLS and participants ranged from 24 to 81 years old, reflecting the broad clinical spectrum of this condition. Each received a single treatment involving intra- and subdermal injection of autologous nanofat (40 cc) and SVF (2-3 cc) into vulvar and perianal regions. Clinical follow-up occurred at 1, 3, 6, and 12 months. Symptom severity (clinical score system, CSS), itching (5D Itch Scale), quality of life (Skindex-29), and sexual function (Female Sexual Function Index, FSFI) were assessed using validated scales. Pre- and 12-month biopsies were analyzed histologically and immunohistochemically for markers such as stromal hyalinization, microvascular density, and T-cell infiltration. Results: Statistically significant reductions in CSS symptoms (from 20.12 to 4.71, P = .0025), CSS signs (from 5.79 to 2.00, P = .0014), and Itching 5D (from 6.82 to 2.35, P = .0136) were observed at 12 months. The quality of life improved (Skindex-29: from 42.88 to 24.82, P = .0313). FSFI scores showed nonsignificant improvement. Histologically, a marked reduction in stromal hyalinization (P = .0036) and CD3+ T-cell infiltration (P = .0068), along with increased microvascular density (P = .0121), confirmed regenerative effects. No serious adverse events occurred. Conclusions: The Lichen-SVF protocol offers a safe and effective regenerative option for women with VLS who do not respond to standard treatments. As low-dose corticosteroids were maintained throughout follow-up, the protocol should be viewed as a complementary approach that enhances, rather than replaces, conventional therapy.