Department of Dermatology, Royal North Shore Hospital, Reserve Rd, St Leonards, New South Wales, Australia.
The University of Sydney, Northern Clinical School, St Leonards, New South Wales, Australia.
Trials. 2024 Mar 12;25(1):181. doi: 10.1186/s13063-024-08022-y.
Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to direct therapy for VLP. This randomised controlled trial will be the first double-blinded study comparing systemic treatments in VLP and aims to investigate the safety and efficacy of deucravacitinib compared to methotrexate, in patients with VLP who have failed treatment with potent topical corticosteroids.
A total of 116 women aged ≥ 18 years with moderate to severe VLP (Genital Erosive Lichen Planus (GELP) score ≥ 5) will be recruited. All participants will initially be treated with Diprosone® OV daily, and their outcome will be assessed using the GELP score. At 8 weeks' follow-up, responders (GELP < 5) will be continued on Diprosone® OV. Non-responders (GELP ≥ 5) will be randomised 1:1 in a blinded fashion to receive (i) methotrexate 10 mg weekly + placebo tablet twice daily + folic acid 5 mg weekly or (ii) deucravacitinib 6 mg twice daily + placebo tablet weekly + folic acid 5 mg weekly. The primary endpoint is the difference in the mean change of GELP scores from baseline to week 32 between deucravacitinib and methotrexate groups.
High-quality evidence guiding the management of women with VLP is lacking. Once completed, this will be the first double-blinded RCT to compare systemic treatments in VLP. The results of this study will provide valuable, high-quality data to guide second-line therapy options for VLP that is recalcitrant to potent topical corticosteroids.
Australian New Zealand Clinical Trials Registry ACTRN12623000682640. Registered on 26 June 2023.
外阴硬化性苔藓（VLP）是一种难以治疗的慢性外阴皮肤病，如果没有足够的治疗，会严重影响生活质量。目前缺乏高质量的证据来指导 VLP 的治疗。这项随机对照试验将是第一项比较 VLP 系统治疗的双盲研究，旨在研究与甲氨蝶呤相比，在接受强效外用皮质类固醇治疗失败的 VLP 患者中，德夸鲁瓦替尼的安全性和有效性。
共招募 116 名年龄≥18 岁、患有中重度 VLP（外阴侵蚀性苔藓评分[GELP]≥5）的女性。所有参与者最初将每天接受 Diprosone® OV 治疗，并使用 GELP 评分评估他们的疗效。在 8 周的随访中，GELP<5 的患者将继续接受 Diprosone® OV 治疗。GELP≥5 的非应答者将以 1:1 的比例进行盲法随机分组，分别接受（i）甲氨蝶呤 10mg 每周+安慰剂片剂每日两次+叶酸 5mg 每周或（ii）德夸鲁瓦替尼 6mg 每日两次+安慰剂片剂每周+叶酸 5mg 每周。主要终点是德夸鲁瓦替尼组和甲氨蝶呤组从基线到第 32 周时 GELP 评分的平均变化差异。
缺乏指导 VLP 女性管理的高质量证据。一旦完成，这将是第一项比较 VLP 系统治疗的双盲 RCT。该研究的结果将为指导对强效外用皮质类固醇耐药的 VLP 的二线治疗选择提供有价值的高质量数据。
澳大利亚和新西兰临床试验注册中心 ACTRN12623000682640。于 2023 年 6 月 26 日注册。
