Combination topical therapy for initial treatment of vulvar lichen sclerosus in adult women
Murray, Danielle Claire
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INTRODUCTION: Vulvar lichen sclerosus (LS) is characterized by thinning of the epithelium, and whitening of the vulvar skin which can lead to the characteristic symptoms of burning and itching. There is no cure for vulvar LS and topical corticosteroids are first-line treatment. The aims of this thesis are to propose a study to determine whether topical combination therapy with an ultra-potent corticosteroid and calcineurin inhibitor leads to greater improvement in symptoms and clinical appearance of disease than traditional first-line treatment with an ultra-potent corticosteroid alone, and to evaluate relapse rates between the combination therapy group compared to the topical corticosteroid only group. REVIEW OF LITERATURE: The ultra-potent corticosteroid clobetasol propionate is currently the first-line treatment for women with LS however not all patients achieve remission, and many patients have relapses. Topical calcineurin inhibitors such as tacrolimus are considered to be second-line treatments for vulvar LS and may eliminate the side effects of thinning that can occur with long-term therapy with corticosteroids. METHODS: A single-center randomized control trial will be conducted with post-menopausal women recruited from the dermatology and gynecology at Boston Medical Center. The patients will be randomized to either three months treatment with daily clobetasol propionate in the morning and tacrolimus ointment in the evening, or clobestasol propionate in the morning with a vehicle ointment in the evening. The patients will be evaluated for improvement in symptoms of burning and itching, and for clinical appearance of erythema, whitening of the skin, and hyperkeratosis, purpuric lesions and excoriations. The patients will also be followed for a year post-treatment for signs of relapse. CONCLUSION: The incidence of vulvar LS is increasing and may be under-reported. Though corticosteroids are an effective treatment for most patients, combination therapy with topical tacrolimus may increase the proportion of patients who achieve remission for vulvar LS and will improve their quality of life.