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Updated: Jun 24, 2025

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在用克拉斯科特治疗的患者中,下丘脑-垂体-上腺轴响应
Journal of drugs in dermatology : JDD
|June 4, 2024
概括
克拉斯科特 1% 奶油可以在患者中引起轻度的,暂时的下丘脑-垂体-上腺 (HPA) 轴抑制. HPA轴抑制的实验室迹象在四周内消失,没有观察到临床影响.
科学领域:
- 皮肤病学 皮肤病学
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 克拉斯科特 1% 乳液是12岁及以上患者的局部雄激素受体抑制剂,用于治疗.
- 这项研究详细介绍了在clascoterone开发过程中出现下丘脑-垂体-上腺 (HPA) 轴抑制的实验室迹象的患者.
研究的目的:
- 为了评估在接受 1% 克拉斯科特龙奶油治疗的患者中对下丘脑-垂体-上腺 (HPA) 轴的抑制.
- 评估HPA轴抑制的可逆性及其临床意义.
主要方法:
- 两项2期,开放标签,多中心试验 (NCT01831960,NCT02720627) 招募了9岁至成年患者,患有中度至严重的.
- 患者在14天内每天两次使用1%的克拉斯科特龙奶油. 上腺抑制在基线和第14天使用共热激素刺激试验 (CST) 进行评估.
- 大约4周后,对有异常结果的患者进行了后续的CST. 安全评估包括不良事件和体检.
主要成果:
- 在69名用克拉斯科特治疗的患者中,有5名在第14天显示出异常的CST结果,这表明实验室的HPA轴抑制.
- 在成人和青少年 (9至<18岁) 中观察到异常.
- 在4周的随访期间,所有患者的皮质醇水平都恢复正常. 在CST结果和clascoterone血度或药物剂量之间没有发现相关性. 没有报告有临床意义的不良事件.
结论:
- 克拉斯科特 1% 奶油可以在最大使用条件下诱导轻度,可逆的HPA轴抑制实验室证据.
- 观察到的HPA轴抑制是暂时的,并没有导致临床相关的不良事件或上腺抑制的迹象.
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