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5%外用米诺地尔治疗休止期脱发:一项开放标签单臂临床试验

Use of 5% Topical Minoxidil Application for Telogen Effluvium: An Open-Label Single-Arm Clinical Trial.

作者信息

Ohyama Manabu, Irisawa Ryokichi, Uchiyama Masaki, Mori Miho, Aoki Kazuhiro, Ueda Yuto, Fujita Toru

机构信息

Department of Dermatology, Kyorin University School of Medicine, Tokyo, Japan.

Department of Dermatology, Tokyo Medical University, Tokyo, Japan.

出版信息

J Dermatol. 2025 Sep;52(9):1351-1359. doi: 10.1111/1346-8138.17844. Epub 2025 Jul 2.

Abstract

Telogen effluvium (TE) is an acute and diffuse hair loss due to an abnormal increase in telogen hair follicles in response to external or internal factors. Recently, TE attracts global interest as a major cause of hair loss as a sequela of COVID-19. Typically, hair shedding in TE is expected to cease around 3-6 months from the onset with spontaneous hair regrowth, once the triggering factor is eliminated. However, the substantial shedding causes heavy psychological stress on patients, and there is no evidence-based treatment. To assess the usefulness of topical minoxidil, which has been reported to improve the hair cycle, for TE, an open-label, single-arm clinical trial was conducted enrolling 12 Japanese subjects (3 men and 9 women) who were diagnosed as TE by experts. For each subject, 1 mL of 5% topical minoxidil lotion was applied to the entire scalp twice daily for 24 weeks. Phototrichogram detected that the terminal hair (≥ 60 μm in diameter) count markedly increased respectively by 12.55 ± 4.99 hairs/cm at week 4 and 11.20 ± 4.79 hairs/cm at week 12 from baseline. In the hair wash test assessment, nearly 70% of the subjects were evaluated as improved at least by 2 grades in the evaluation scale (more than 100 shed hair decrease in the count) from baseline. Of note, all investigators and subjects reported notable improvement at week 24 respectively in their reported outcomes. Adverse event was minimal and within the known safety profile of topical minoxidil. Self-healing nature of TE and small sample size represented major factors affecting the validity of the study. Considering its safety profile and wide-availability, topical minoxidil lotion may be helpful in the management of TE making the patients reassured at earlier stage of clinical course. Still, it should be noted that this application is an off-label use.

摘要

休止期脱发(TE)是一种急性弥漫性脱发,由于休止期毛囊对外部或内部因素的反应异常增加所致。最近,TE作为新冠后遗症导致脱发的主要原因,引起了全球关注。通常情况下,一旦触发因素消除,TE的脱发预计在发病后3至6个月左右停止,头发会自然再生。然而,大量脱发给患者带来了沉重的心理压力,且尚无循证治疗方法。为评估已报道可改善毛发周期的外用米诺地尔对TE的有效性,开展了一项开放标签、单臂临床试验,纳入12名经专家诊断为TE的日本受试者(3名男性和9名女性)。对每位受试者,每天两次将1毫升5%外用米诺地尔洗剂涂抹于整个头皮,持续24周。毛发显微镜检查发现,终毛(直径≥60μm)数量从基线分别在第4周显著增加12.55±4.99根/平方厘米,在第12周增加11.20±4.79根/平方厘米。在洗头试验评估中,近70%的受试者在评估量表中至少改善了2个等级(脱发计数减少超过100根)。值得注意的是,所有研究者和受试者在第24周分别报告其结果有显著改善。不良事件极少,且在外用米诺地尔已知的安全范围内。TE的自愈特性和小样本量是影响该研究有效性的主要因素。考虑到其安全性和广泛可用性,外用米诺地尔洗剂可能有助于TE的治疗,使患者在临床病程早期感到安心。不过,应注意这种应用属于超说明书用药。

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