Topical Tacrolimus for Lichen Sclerosus: Systematic Review of Efficacy and Safety

Introduction: Lichen sclerosus (LS) is a chronic inflammatory dermatosis affecting both genital and extragenital sites, with a prevalence of approximately 3% among females in the United Kingdom, particularly in the post-menopausal population. Although its etiology remains incompletely understood, LS can significantly impair quality of life through pain, pruritus, and scarring 1. Current guidelines recommend potent topical corticosteroids, most commonly clobetasol, as first-line therapy 2; however, long-term use is limited by adverse effects such as skin atrophy 3. Objectives: This systematic review evaluates the efficacy and safety of topical tacrolimus in the management of lichen sclerosus. Methods: A comprehensive literature search was conducted in accordance with PRISMA guidelines 4. Fourteen randomized controlled trials comprising 335 patients with lichen sclerosus were included. Results: Of the included patients, 2% (N=6) presented with extragenital disease and 98% (N=331) with anogenital involvement. Most patients (81%, N=272) were treated with topical tacrolimus 0.1% twice daily, while 19% (N=63) received clobetasol as a comparator. Clinical improvement, ranging from partial symptom relief to complete remission, was observed in 90% (N=244) of tacrolimus-treated patients. Severe adverse events requiring discontinuation were rare (1%, N=3). Compared with corticosteroids, tacrolimus was associated with superior patient-reported outcomes, clinician-reported improvement, and histological response. Conclusion: Topical tacrolimus appears to be a safe and effective therapeutic option for lichen sclerosus, demonstrating favorable clinical and histological outcomes with minimal adverse effects. Further long-term prospective trials are needed to confirm its comparative efficacy, safety, and role in future treatment guidelines.