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一项评估 2.4%甘珀酸氯铵布治疗手掌多汗症的疗效和安全性的开放性队列研究。

Open-Label Cohort Study to Evaluate Efficacy and Safety of Application of Glycopyrronium Cloth, 2.4% for Palmar Hyperhidrosis.

出版信息

J Drugs Dermatol. 2022 May 1;21(5):488-495. doi: 10.36849/JDD.6688.

DOI:10.36849/JDD.6688
PMID:35533035
Abstract

BACKGROUND

Hyperhidrosis of the palms has a significant negative impact on quality of life. There is no FDA-approved treatment; however, clinicians often use glycopyrronium cloth off-label for this indication despite the lack of published guidance on optimal method of application for treatment of palms.

OBJECTIVE

To compare the safety and efficacy of 4 different methods of application of glycopyrronium cloth to give clinicians guidance when treating palmar hyperhidrosis.

STUDY DESIGN

This study, conducted completely virtually using live interactive telemedicine, compared application times of 15 minutes, 30 minutes, and overnight without occlusion and 30 minutes under occlusion. The primary endpoint was a decrease in the mean of the Hand Severity Score (HHS) after 4 weeks of once-daily application. Safety data, including local skin reactions and other adverse events, were tabulated by cohort.

RESULTS

Of the application times and methods tested, 30 minutes without occlusion produced the greatest decrease in the HHS with an acceptable safety profile. The most common adverse event was unilateral mydriasis, which presumably occurred from inadvertent introduction of study drug into the eye despite multiple warnings to the subjects to avoid eye contact. A few subjects had adverse events presumably due to systemic absorption of the drug similar to those seen in the pivotal trials for treatment of axillary hyperhidrosis.

CONCLUSION

Glycopyrronium cloth can be used successfully to treat palmar hyperhidrosis. Occlusion for 30 minutes had the poorest response presumably due to the increased sweating causing dilution of the study drug.

CLINICALTRIALS

gov: NCT04906655 J Drugs Dermatol. 2022;21(5):488-494. doi:10.36849/JDD.6688.

摘要

背景

手掌多汗症对生活质量有重大负面影响。目前尚无获得 FDA 批准的治疗方法;然而,尽管缺乏关于治疗手掌多汗症的最佳应用方法的发表指南,临床医生仍经常将格隆溴铵布开处方用于该适应证。

目的

比较格隆溴铵布 4 种不同应用方法的安全性和疗效,为临床医生治疗手掌多汗症提供指导。

研究设计

本研究完全通过实时互动远程医疗进行,比较了 15 分钟、30 分钟和过夜(不包扎)以及 30 分钟包扎的应用时间。主要终点是在每日一次应用 4 周后,手严重程度评分(HHS)的平均值下降。按队列列出了安全性数据,包括局部皮肤反应和其他不良事件。

结果

在所测试的应用时间和方法中,不包扎 30 分钟的 HHS 下降最大,且具有可接受的安全性。最常见的不良事件是单侧瞳孔散大,推测是由于尽管多次警告患者避免眼部接触,但研究药物仍意外进入眼睛。少数患者发生了不良事件,推测是由于药物全身吸收所致,类似于治疗腋窝多汗症的关键性试验中所见。

结论

格隆溴铵布可成功用于治疗手掌多汗症。包扎 30 分钟的反应最差,推测是由于出汗增加导致研究药物稀释。

临床试验

gov:NCT04906655 J 皮肤病药物杂志。2022;21(5):488-494. doi:10.36849/JDD.6688.

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