Testosterone Versus Clobetasol for Maintenance of Vulvar Lichen Sclerosus Associated With Variable Degrees of Squamous Cell Hyperplasia

Abstract

What used to be called vulvar dystrophy now is termed nonneoplastic epithelial disorders of the vulva. Within this category, the association of lichen sclerosus with varying degrees of squamous cell hyperplasia is referred to as mixed disease. This retrospective study compared responses to treatment with testosterone and clobetasol in 83 women having biopsy-proved vulvar mixed disease. All patients were initially treated with topical fluorinated corticosteroids for 6 weeks. They were then treated with either 2% testosterone propionate in petrolatum (n = 44) or 0.05% clobetasol 17-propionate cream (n = 39), each applied once a day. After symptoms were optimally controlled, twice weekly applications were advised for 3 months and treatment then was continued on an as-needed basis. The major complaints were vulvar itching and burning or discomfort. Remission rates after 6 months were 82% in women treated with testosterone and 93% in those treated with clobetasol. Disease recurred in 8% of patients: 13% of women treated with testosterone and 5% of clobetasol-treated patients. The median time to recurrence was 9 months. Persistent disease was documented histologically in 60% of patients whose symptoms did not respond to treatment. Skinning vulvectomy ultimately was performed in 2 patients with recurrent disease and 2 with vulvar intraepithelial neoplasia I–II or atypical squamous hyperplasia. Treatment was not associated with steroid vulvar atrophy or other serious complications. Both topical treatments evaluated in this retrospective study yielded excellent remission rates. Clobetasol led to a higher remission rate and lower recurrence rate than did testosterone therapy, but the differences were not statistically significant. Patients with mixed disease who fail to respond symptomatically should have a vulvar biopsy to rule out atypical components.