One-year outcome after laser treatment of vulvar lichen sclerosus: a prospective observational trial

Abstract

Purpose

To assess the 12-month efficacy of a novel non-ablative dual Nd:YAG/Er:YAG laser therapy for vulvar lichen sclerosus (LS) and to evaluate the impact of crossover laser treatment following initial topical corticosteroid therapy.

Methods

This study presents the 1-year data of a prospective observational trial. Between baseline and 6 months, women with vulvar LS were randomized to receive either dual Nd:YAG/Er:YAG laser therapy or topical clobetasol propionate. Between 6 and 12 months, optional steroid or laser therapies were offered.

Results

In the laser group, 34 of 44 patients (77%) required no additional treatment between 6 and 12 months, indicating sustained treatment effects. The total LS score improved significantly during this period (mean change -0.35 ± 0.60; 95% CI -0.56 to -0.14; p = 0.004), while other parameters showed non-significant improvements. In the corticosteroid group, 20 of 22 patients (91%) opted for a crossover to laser therapy. Following three laser sessions, the total LS score improved markedly (mean change -1.50 ± 0.83; 95% CI -1.89 to -1.11; p < 0.001), primarily driven by a reduction in atrophy (p < 0.001). Patient-reported improvement (PGI-I) increased from 45 to 77% (p = 0.008). At the 12-month follow-up, outcomes were comparable between the two study groups.

Conclusion

Non-ablative dual Nd:YAG/Er:YAG laser therapy resulted in significant and sustained clinical improvement in vulvar LS over 12 months. Crossover to laser therapy after initial corticosteroid treatment further enhanced both objective and subjective outcomes.

Clinical trial identification number

NCT03926299; date of registration: 24 April 2019.