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

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. Objective: 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 a 3-month treatment with topical corticosteroid. Methods: 27 patients affected with VLS were enrolled into a 12-week active treatment phase (AP) with topical 0.1% mometasone furoate 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 or a cold cream once daily or topical vitamin E once daily. The primary efficacy parameters were the relapse rate and the mean time of relapse. Results: 25 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: 5 in the vitamin E group (55.6%) and 5 in the cold cream group (62.5%), 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 0.1% mometasone furoate 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.