Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: Preliminary results of a randomized study

摘要

Background The chronic and relapsing nature of vulvar lichen sclerosus (VLS) represents a challenge for its long-term management after an effective treatment with topical corticosteroids. Objectives To assess the effectiveness of proactive, twice-weekly application of mometasone furoate 0·1% ointment, compared with daily topical vitamin E or cold cream, in keeping VLS in remission and reducing the risk of relapse after 3 months of treatment with topical corticosteroid. Methods In total, 27 patients affected with VLS were enrolled into a 12-week active treatment phase (AP) with topical mometasone furoate 0·1% ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase (MP) in which patients were randomized to apply either mometasone furoate 0·1% ointment twice weekly, a cold cream once daily or topical vitamin E once daily. The primary efficacy parameters were the relapse rate and the mean time to relapse. Results Twenty-five patients considered to have been completely or almost completely healed after the AP entered the MP. By the end of the 52-week MP, 10 patients (40%) experienced a relapse: five in the vitamin E group (56%) and five in the cold cream group (62%), while no patient in the mometasone furoate 0·1% ointment group had a relapse. The occurrence of VLS relapse for patients in therapy with both vitamin E and cold cream was significantly higher than for those in proactive therapy with topical corticosteroid. The median time to relapse was the same (21·6 weeks) for the vitamin E and the emollient groups. Conclusions Once VLS has been stabilized with topical corticosteroids, twice-weekly proactive application of mometasone furoate 0·1% ointment over 56 weeks was found to be an effective and safe therapy option in maintaining VLS remission and in preventing the occurrence of relapse. What's already known about this topic? Despite the chronic relapsing nature of vulvar lichen sclerosus (VLS), to date no guidelines are available for the long-term maintenance of this disease after an effective treatment with corticosteroids. What does this study add? Our results appear to indicate that proactive treatment with a topical corticosteroid twice weekly may be an effective, safe and reliable therapy for the long-term prevention of relapse in VLS previously treated with topical corticosteroid, and for maintaining VLS remission.