Background: Vulvar lichen sclerosus (LS), a poorly recognized chronic inflammatory skin disease, may represent a therapeutic challenge. Pimecrolimus cream 1% is a nonsteroidal, selective inflammatory cytokine inhibitor that has recently been indicated for some inflammatory cutaneous diseases.
Objective: To investigate the efficacy, tolerability, and safety of 1% pimecrolimus cream therapy in postmenopausal women with LS.
Methods: A total of 16 patients applied pimecrolimus cream 1% twice a day over the first 3 months and then as required. All the patients completed this study and were then followed up over the next 12 months. The symptoms and clinical appearance of the lesions in every subject were recorded before and after treatment using a severity scale.
Results: Using pimecrolimus, most of the patients exhibited a significant improvement with respect to symptoms and the clinical appearance of the disease. After 3 months of treatment, complete remission was seen in 11 patients, partial remission in four, whereas one patient experienced no response at all. Over the subsequent 12 months of follow-up, 10 patients exhibited complete remission while five had partial remission. Four cases with complete remission experienced a few relapses during the follow-up period. Older patients and those with an advanced stage of the disease responded poorly. No significant side effects were observed.
Conclusions: Pimecrolimus cream 1% appears to be an effective and well-tolerated therapeutic alternative option in the treatment of early stage of vulvar LS. Pimecrolimus may reduce the incidence of flare ups, improve long-term disease control, and enhance the patients' quality of life, especially in postmenopausal women.