Department of Clinical and Experimental Medicine, Section of Dermatology, University of Ferrara, Via Savonarola 9, 44121, Ferrara, Italy.
Br J Dermatol. 2013 Jun;168(6):1316-24. doi: 10.1111/bjd.12273.
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.
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.
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.
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.
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.
外阴硬化性苔藓（VLS）具有慢性和复发性，在外用皮质类固醇治疗有效后，长期管理存在挑战。
评估在接受外用皮质类固醇治疗 3 个月后，与每日外用维生素 E 或冷霜相比，积极、每周两次应用莫米松糠酸酯 0.1%软膏，对外阴硬化性苔藓维持缓解和降低复发风险的效果。
共有 27 例 VLS 患者入组 12 周的活性治疗期（AP），每日接受莫米松糠酸酯 0.1%软膏治疗。达到疾病缓解的患者进入 52 周的维持期（MP），其中患者随机分为每周两次应用莫米松糠酸酯 0.1%软膏、每日一次应用冷霜或每日一次应用维生素 E。主要疗效参数为复发率和复发的平均时间。
AP 结束后，25 例患者被认为完全或几乎完全愈合，进入 MP。在 52 周 MP 结束时，10 例患者（40%）出现复发：维生素 E 组 5 例（56%），冷霜组 5 例（62%），而莫米松糠酸酯 0.1%软膏组无患者复发。维生素 E 和冷霜治疗组患者 VLS 复发的发生率明显高于积极外用皮质类固醇治疗组。维生素 E 组和赋形剂组的复发中位时间相同（21.6 周）。
在外用皮质类固醇稳定 VLS 后，发现在 56 周内每周两次积极应用莫米松糠酸酯 0.1%软膏，是维持 VLS 缓解和预防复发的有效和安全治疗选择。
