Background: Lichen Planopilaris (LPP) is a primary scarring alopecia with unknown etiology and its management is a challenge for dermatologists. We aimed to compare the safety and efficacy of methotrexate and cyclosporine in LPP patients. Methods: In a randomized clinical trials, 33 patients were randomly allocated to receive either 15-mg oral methotrexate per week or 3–5-mg/kg/day cyclosporine for six months. During the treatment course, side effects, signs/symptoms and laboratory test were assessed periodically. Lichen planopilaris activity index (LPPAI) was measured at baseline and 2, 4, and 6 months after the intervention. Score of both photography and patient’s opinion were also obtained. The collected data were analyzed in SPSS software (Ver.25.0. Armonk, NY: IBM Corp). Results: Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05). Conclusions: Regarding the results of the present study, both cyclosporine and methotrexate are effective in treating refractory lichen planopilaris and we propose methotrexate as a possible earlier choice over cyclosporine.

This study was registered in Iranian Registry of Clinical Trials (IRCT20190717044256N1).

背景：扁平苔藓（LPP）是一种病因不明的主要瘢痕性脱发，其管理对皮肤科医生来说是一个挑战。我们旨在比较甲氨蝶呤和环孢素在LPP患者中的安全性和有效性。方法：在一项随机临床试验中，将33例患者随机分配为每周接受15 mg甲氨蝶呤或3–5 mg / kg /天环孢素口服治疗，共6个月。在治疗过程中，定期评估副作用，体征/症状和实验室检查。在基线，干预后第2、4和6个月测量扁平苔藓活动指数（LPPAI）。还获得了摄影得分和患者意见。收集的数据在SPSS软件（版本25.0，纽约州阿蒙克，IBM公司）中进行了分析。结果：两种药物均对LPP的体征和症状产生积极影响，各变量之间存在显着差异（p <0.05），结果显示在使用环孢素和甲氨蝶呤治疗的第6个月末疗效相似（p> 0.05） 。结论：关于本研究的结果，环孢霉素和甲氨蝶呤均能有效治疗难治性扁平苔藓，我们建议甲氨蝶呤作为较环孢霉素更早的选择。

该研究已在伊朗临床试验注册中心（IRCT20190717044256N1）中进行了注册。