Efficacy and Safety of Laser Treatment in Vulvar Lichen Sclerosus: A Systematic Review.

Objectives: This study systematically reviews randomized controlled trials (RCTs) evaluating laser therapy for vulvar lichen sclerosus (VLS) to assess its efficacy and safety, aiming to inform clinical management and guideline development.

Methods: RCTs on laser treatment for VLS were retrieved from PubMed, Embase, Web of Science, and Cochrane databases up to January 2025, limited to English literature. References from included studies were also screened. Data on study characteristics, laser parameters, outcome measures, measurement tools, and assessment time points were extracted and analyzed.

Results: Seven RCTs (332 patients) reported 19 outcomes and 19 measurement tools, each used a total of 28 times. Symptoms and signs were most frequently reported and commonly measured using the Visual Analog Scale (VAS). Most trials indicated improvements in symptoms, signs, quality of life (QoL), and histology after laser therapy. Three studies reported greater symptom/sign improvement than topical corticosteroids (p < 0.05), and three found higher patient satisfaction (p < 0.05). Two studies showed good tolerability via VAS. Adverse events occurred in five studies (147 patients), including five mild cases (local irritation, blisters, urinary tract infection, itching, and pain). Due to heterogeneity and low study quality, a meta-analysis was not performed.

Conclusions: Laser therapy improves symptoms/signs, QoL, and histological outcomes in VLS, with good safety and tolerability. However, the evidence supporting its use as a monotherapy is limited, and benefits for anti-inflammatory, anti-fibrotic, scar-preventive, or anticarcinogenic effects remain unproven. Large-scale, long-term, and high-quality trials are needed, and future research should establish standardized Core Outcome and Measurement Sets to optimize VLS management.