Vulvar lichen sclerosus in postmenopausal women: a comparative study for treating advanced disease with clobetasol propionate 0.05%.

BACKGROUND AND OBJECTIVE: Clobetasol propionate 0.05% has been the mainstay in treating vulvar lichen sclerosus (VLS) for the past ten years. The usual length of therapy is two to 12 weeks. We conducted this study to evaluate the efficacy and safety of treating severe lesions of VLS in postmenopausal women for a longer time on a regular basis using clobetasol propionate.

MATERIALS AND METHODS: From 1997-2000, 137 women with VLS were examined in the Colposcopy and Laser Surgery Unit of "Alexandra" Hospital. Patients who were premenopausal, had previous therapy, exhibited mild or moderate disease or showed VIN or invasive cancer on vulvar biopsies were excluded from the study. The remaining women were divided into two groups. The first group applied clobetasol propionate 0.05% for three months and afterwards on an "as required" basis, whereas the second group used the ointment for six months on a regular basis. All patients were examined at two, three, six and 12 months following treatment. Signs and symptoms before and after therapy as well as side-effects caused by the ointment were recorded.

RESULTS: The mean age of the women was 60.2 years. Fifty-four patients were divided into two categories. In the 6-month follow-up, 59% of the 1st group and 85% of the second had complete response regarding their symptoms whereas on the 12-month follow-up, the respective numbers were 48% and 74%. Concerning the signs, 30% of the first group and 55.5% of the second showed to have complete response after six months and 26% and 41% respectively after 12 months. All differences between the two groups, except the signs after 12 months, were statistically significant. There were no side-effects from the long-term use of clobetasol propionate 0.05%.

CONCLUSIONS: Conservative management of severe lesions of VLS in postmenopausal women using clobetasol propionate 0.05% for a long time (6 months) on a regular basis, seems to be a safe and effective therapy. Improvement is observed primarily on the symptoms and less on the signs.