Researchers have found in a new study that Lichen sclerosus is linked to a significantly increased risk of vulvar dysplasia and cancer. Clobetasol therapy appears to offer protective benefits against neoplastic transformation, especially when used early in the disease course. Topical calcineurin inhibitors do not show an association with increased risk of dysplasia or malignancy. The study was published in the American Journal of Obstetrics & Gynecology by Paige E. and colleagues.
The main aim of this study is to assess the risk of vulvar dysplasia and malignancy in women with vulvar lichen sclerosus, as well as to determine the effect of vulvovaginal treatment with topical clobetasol or topical calcineurin inhibitors compared to controls.
This was a population-level retrospective cohort study conducted through the TriNetX research network, which encompasses the electronic health records and claims information of patients living in the United States and Europe. A total of 55,696 patients with lichen sclerosus, as well as those exposed to clobetasol and topical calcineurin inhibitors, and treated with clobetasol or topical calcineurin inhibitors, were selected, and matched controls based on their risk status at baseline were identified. A total of 14,430 patients exposed to clobetasol, as well as 6,227 exposed to topical calcineurin inhibitors, were selected, and matched corticosteroid-naïve patients served as controls. Furthermore, 7,239 patients treated with clobetasol were
The major endpoints were the occurrence of vulvar dysplasia and/or vulvar malignancy within 10 years. Risk ratios with 95% confidence limits were computed for the results, and Kaplan-Meier survival curves and log-rank testing were used for assessment of cumulative probabilities. Significance was set at a probability value less than 0.05.
Key Findings
- Lichen sclerosus was found to be significantly linked to neoplastic endpoints over 10 years. Individuals with lichen sclerosus had a concurrent 11-fold and 8-fold higher risk of vulvar malignancy (RR, 11.08; 95 CI, 8.92, 13.76) and vulvar dysplasia (RR, 8.04; 95 CI, 6.47, 9.98), respectively.
- In the cohort receiving treatment, the use of topical clobetasol was found to have a relative risk reduction for vulvar malignancy, with a significant protective effect in relation to vulvar malignancy at 2 years (RR, 0.62; 95% CI, 0.42-0.94).
- However, topical calcineurin inhibitors were not found to provide a higher relative risk for vulvar dysplasia and malignancy at any point in time evaluated in the study.
- Notably, there were no significant differences in cancer/dysplasia risk when clobetasol users were compared to those using topical calcineurin inhibitors.
In this large population-based study, lichen sclerosus was found to be significantly associated with the risk of vulvar dysplasia and malignancy, and topical clobetasol was found to be significantly protective for the risk of malignant transformation. Topical calcineurin inhibitors were not found to be significantly associated with the risk of neoplasia.
Reference:
Adams, P. E., Vikram, E. P., Curman, P., Kraus, C. N., & Amber, K. T. (2025). Topical therapy and vulvar malignancy risk in lichen sclerosus: A large propensity-matched study. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2025.12.043
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