A Prospective Study to Assess for Histologic Changes on Vulvar Biopsies in Postmenopausal Women With Lichen Sclerosus Treated With Fractionated CO2 Laser Therapy [ID: 1339895]

INTRODUCTION: Lichen sclerosus (LS) is a chronic skin condition affecting men and women of all ages. Fractionated carbon dioxide (FxCO2) laser therapy has been proposed as a novel treatment modality. Our objective was to investigate histologic changes after FxCO2 laser therapy for vulvar LS and assess symptomatic improvement using the Skindex-16 questionnaire. METHODS: This prospective single-arm study was conducted from April 2021 to August 2022 at one academic medical center. Ten English-speaking postmenopausal women with biopsy-proven LS undergoing FxCO2 laser treatment were enrolled. Exclusion criteria included prior transvaginal mesh for prolapse, recent topical corticosteroid use, prior pelvic radiation, malignancy, active genital infection, or pregnancy. Institutional review board approval and written consent from participants were obtained. The vulvovaginal SmartXide2-V2-LR laser system FxCO2 laser (DEKA, Calenzano, Italy) was used to treat visually affected areas of vulvar and perianal LS with a single pass over three treatments spaced 4–6 weeks apart. Participants completed the Skindex-16 questionnaire and underwent vulvar biopsy at baseline and 4 weeks after the third FxCO2 laser therapy. Histologic slides were blinded and then scored by a dermatopathologist (MC) on a 5-point scale to assess sclerosus, inflammation, and epidermal atrophy. RESULTS: Participants had a mean age of 61 and were mostly White, privately insured with college/graduate-level education. Posttreatment vulvar biopsies showed significant improvement in sclerosus and epidermal atrophy (P<.05) with no statistically significant change in inflammation or Skindex-16 scores after FxCO2 laser treatment. A statistically significant correlation was found between sclerosus and Skindex-16 symptoms score (mean change of 21.4 units in Skindex-16 symptoms score for 1 unit change in histologic sclerosus score, P=.03). CONCLUSION: In postmenopausal women with vulvar LS undergoing FxCO2 laser therapy, symptomatic improvements are correlated with histologic changes in sclerosus on vulvar biopsy. FxCO2 laser therapy is a promising option for treatment of LS, and further studies are needed to assess safety and efficacy.