Nd:YAG/Er:YAG dual laser compared with topical steroid to treat vulvar lichen sclerosus: A randomised controlled trial

• Published in: BJOG : an international journal of obstetrics and gynaecology 2024-05, Vol.131 (6), p.740-749
• Main Authors: Zivanovic, Irena, Gamper, Marianne, Fesslmeier, Debra, Walser, Claudia, Regauer, Sigrid, Viereck, Volker
• Format: Article
• Language: English
• Subjects: clobetasol propionate; Genital diseases; laser safety; Lasers; lichen sclerosus; non‐ablative Nd:YAG/Er:YAG laser therapy; Patient satisfaction; Patients; prospective randomised controlled trial; steroid therapy; Steroids
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/1471-0528.17737

Objective To evaluate the efficacy and safety of a novel non‐ablative Nd:YAG/Er:YAG dual laser treatment for vulvar lichen sclerosus (LS) in comparison with the recommended first‐line therapy with topical steroid. Design A randomised investigator‐initiated active‐controlled trial. Setting Single tertiary referral centre. Population Women with vulvar LS. Methods Randomisation (2:1) to Nd:YAG/Er:YAG laser therapy or topical clobetasol proprionate therapy. Four laser treatments at 0, 1, 2 and 4 months or decreasing doses of steroid for 6 months. Main Outcome Measures The primary outcome was the change in objective validated clinical LS score in the laser arm between baseline and 6 months. Secondary outcomes were laser tolerability/safety, symptom scores and patient satisfaction. Results Sixty‐six women were included, 44 in the laser group and 22 in the steroid group. The total LS score decreased by −2.34 ± 1.20 (95% CI −2.71 to −1.98) in women treated with laser compared with a decrease of −0.95 ± 0.90 (95% CI −1.35 to −0.56) in those receiving steroid applications (p