A prospective pilot study to assess for histologic changes on vulvar biopsies in postmenopausal women with lichen sclerosus treated with fractionated CO2 laser therapy

• Published in: Lasers in surgery and medicine 2023-08, Vol.55 (6), p.521-527
• Main Authors: Dieter, Alexis A., Iglesia, Cheryl B., Lee, Jennifer H., Etcheverry, Maria J., Gonzales, Melissa K., Sokol, Andrew I., Tefera, Eshetu, Cardis, Michael A.
• Format: Article
• Language: English
• Subjects: Atrophy; Biopsy; Carbon dioxide; carbon dioxide laser; Carbon dioxide lasers; Colleges & universities; Health care facilities; histology; Histopathology; Inflammation; laser therapy; Lasers; lichen sclerosus; Malignancy; Post-menopause; Questionnaires; Radiation; Sclerosis; Statistical analysis; Therapy; vulvar biopsy; vulvar diseases; vulvar lichen sclerosus
• ISSN: 0196-8092; 1096-9101
• DOI: 10.1002/lsm.23669

Objectives To investigate the histologic characteristics of vulvar tissues before and after completion of fractionated carbon dioxide (CO2) laser therapy (FxCO2) for vulvar lichen sclerosus (LS). The secondary objective was to assess subjective improvement in symptoms via the Skindex‐16 questionnaire. Methods This prospective single‐arm study was conducted from April 2021 to August 2022 at one academic medical center. Ten postmenopausal women with biopsy‐proven LS planning FxCO2 laser treatment were enrolled. Exclusion criteria included prior transvaginal mesh for prolapse, topical corticosteroid use within 8 weeks, prior pelvic radiation, malignancy, active genital infection, or pregnancy. The vulvovaginal SmartXide2‐V2‐LR laser system fractionated CO2 laser (DEKA) was utilized to treat visually affected areas of vulvar and perianal LS with a single pass. Subjects underwent three treatments 4–6 weeks apart. Subjects completed the Skindex‐16 questionnaire and had vulvar biopsy at baseline and at 4 weeks after completion of fractionated CO2 laser therapy. Blinded histologic slides were scored by one dermatopathologist (Michael A. Cardis) rating from 1 to 5 the degree of dermal sclerosis, inflammation, and epidermal atrophy. Change scores were calculated as the difference between pre‐ and post‐treatment scores for each subject. Results The 10 subjects enrolled had a mean age of 61 and most were white, privately insured, and had a college/graduate‐level education. Post‐fractionated CO2 laser treatment vulvar biopsies showed significant improvement in sclerosis and epidermal atrophy compared with pretreatment baseline biopsy specimens (p  0.05 for both). A statistically significant correlation was found between change in sclerosis and Skindex‐16 symptoms scores with an average change of 21.4 units in Skindex‐16 symptoms score for every one‐point change in histologic sclerosis score (p = 0.03). Conclusions In postmenopausal women with vulvar LS undergoing fractionated CO2 laser, symptomatic improvements correlated with histologic change in degree of sclerosis on vulvar biopsy. These results demonstrate FxCO2 laser therapy as a promising option for the treatment of LS and suggest that further studies should assess degree of sclerosis on histopathology.