塞替哌兰特治疗男性雄激素性脱发：一项随机、双盲、安慰剂对照2a期试验的结果

Setipiprant for Androgenetic Alopecia in Males: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial.

作者信息

DuBois Janet, Bruce Suzanne, Stewart Daniel, Kempers Steven, Harutunian Christy, Boodhoo Terry, Weitzenfeld Amy, Chang-Lin Joan-En

机构信息

DermResearch, Inc., Austin, TX, USA.

Suzanne Bruce and Associates, PA, Houston, TX, USA.

出版信息

Clin Cosmet Investig Dermatol. 2021 Oct 15;14:1507-1517. doi: 10.2147/CCID.S319676. eCollection 2021.

PURPOSE

To evaluate oral setipiprant versus placebo for scalp hair growth in men with androgenetic alopecia (AGA).

PATIENTS AND METHODS

Males aged 18 to 49 years with AGA were enrolled in a double-blind, multicenter, 32-week, phase 2a trial; randomized to twice-daily (BID) 1000-mg (2×500 mg for a total daily dose of 2000 mg) setipiprant tablets or placebo for 24 weeks; and assessed at weeks 4, 8, 16, and 24, with a week 32 follow-up. The study initially included a finasteride 1-mg once-daily group, removed by protocol amendment. Changes from baseline to week 24 in target area hair count (TAHC) and blinded Subject Self-Assessment (SSA) of target area photographs were coprimary efficacy endpoints. Hair growth was also evaluated using blinded Investigator Global Assessment (IGA). Safety assessments included adverse events (AEs) and clinical laboratory tests. Analysis of covariance models were used to test statistical significance for TAHC, SSA, and IGA. Data were summarized without statistical analysis for finasteride.

RESULTS

Randomized subjects (N=169) included 74 placebo, 83 setipiprant, and 12 finasteride subjects; 117 (69.2%) and 113 (66.9%) subjects completed week 24 and 32 visits, respectively. Treatment groups had similar baseline characteristics. Neither coprimary efficacy endpoint was met. At week 24, TAHC and SSA findings indicated no hair growth improvements with setipiprant versus placebo. Setipiprant also did not improve hair growth versus placebo per the IGA. Treatment-related AEs, all mild or moderate in severity, occurred in 12.3%, 25.9%, and 25.0% of the placebo, setipiprant, and finasteride groups, respectively. Two treatment-emergent serious AEs (TESAEs), cellulitis and multiple sclerosis, were reported in the placebo group, both unrelated to treatment. No TESAEs were reported with setipiprant or finasteride.

CONCLUSION

Setipiprant 1000 mg BID was safe and well tolerated but did not demonstrate efficacy versus placebo for scalp hair growth in men with AGA.

目的

评估口服司替哌兰特与安慰剂对雄激素性脱发（AGA）男性头皮毛发生长的影响。

患者和方法

年龄在18至49岁的AGA男性患者参加了一项双盲、多中心、为期32周的2a期试验；随机分为每日两次（BID）服用1000毫克（2×500毫克，每日总剂量2000毫克）司替哌兰特片或安慰剂，持续24周；并在第4、8、16和24周进行评估，随访至第32周。该研究最初包括一个每日一次服用1毫克非那雄胺的组，后根据方案修正将其剔除。从基线到第24周，目标区域毛发计数（TAHC）的变化以及对目标区域照片进行的盲法受试者自我评估（SSA）是共同主要疗效终点。还使用盲法研究者整体评估（IGA）来评估毛发生长情况。安全性评估包括不良事件（AE）和临床实验室检查。采用协方差分析模型来检验TAHC、SSA和IGA的统计学显著性。对非那雄胺的数据进行了总结，但未进行统计分析。

结果

随机分组的受试者（N = 169）包括74名安慰剂组受试者、83名司替哌兰特组受试者和12名非那雄胺组受试者；分别有117名（69.2%）和113名（66.9%）受试者完成了第24周和第32周的访视。各治疗组的基线特征相似。两个共同主要疗效终点均未达到。在第24周时，TAHC和SSA的结果表明，与安慰剂相比，司替哌兰特未改善毛发生长情况。根据IGA评估，司替哌兰特与安慰剂相比也未改善毛发生长。与治疗相关的AE，严重程度均为轻度或中度，分别在安慰剂组、司替哌兰特组和非那雄胺组中的发生率为12.3%、25.9%和25.0%。安慰剂组报告了两例治疗中出现的严重不良事件（TESAEs），即蜂窝织炎和多发性硬化症，均与治疗无关。司替哌兰特组和非那雄胺组均未报告TESAEs。