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ALRV5XR治疗雄激素性脱发和休止期脱发临床试验中的性别差异。

Sex differences in clinical trials of ALRV5XR treatment of androgenetic alopecia and telogen effluvium.

作者信息

Feldman Peter R, Feldman Oriel J, Guevara-Aguirre Jaime, Fiebig Klaus M

机构信息

Arbor Life Labs, Toronto, ON, Canada.

Faculty of Science, Wilfrid Laurier University, Waterloo, ON, Canada.

出版信息

Front Med (Lausanne). 2022 Aug 4;9:918058. doi: 10.3389/fmed.2022.918058. eCollection 2022.

DOI:10.3389/fmed.2022.918058
PMID:36045927
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9421616/
Abstract

INTRODUCTION

ALRV5XR treatment of androgenetic alopecia (AGA) and telogen effluvium (TE) has early evidence of regenerating a normal scalp hair phenotype in both sexes.

DESIGN

We performed two 24-week double-blinded placebo-controlled comparison trials, one in each sex, on the ALRV5XR treatment effect on hair regeneration, in AGA and TE, in 92 AGA subjects (24 also had TE). Forty-six women (age 24-64 years) and 46 men (age 22-63 years) were randomized 1:1 to either ALRV5XR or placebo regimens (one b.i.d. oral capsule and daily administration of shampoo, conditioner, and follicle serum).

EVALUATION

: Absolute and relative changes in terminal hair (TH) density. : Response rate, changes in vellus hair (VH) density, TH/VH ratio, hair diameter, growth, and shedding rate.

RESULTS

Forty-one women (20 ALRV5XR, 21 placebo) and 36 men (17 ALRV5XR, 19 placebo) completed the trials. TH outcome was evaluable for 18 and 21 women and 11 and 11 men (ALRV5XR, placebo, respectively). Efficacy in women: 30.1 THs/cm ( = 0.0002) and 19.7% ( = 0.0016). Efficacy in men: 21.0 THs/cm ( = 0.0014) and 16.4% ( = 0.0012). 66.7% of women and 100% of men responded to ALRV5XR. TH/VH ratio for men increased 33.0% ( = 0.0033). Growth rate in women increased by 30.7 μm/24 h ( < 0.0001) and 10.0% ( < 0.0001). There were no adverse events reported.

CONCLUSION AND RELEVANCE

ALRV5XR induced significant regrowth of TH. Accelerating regrowth by reactivation of dormant telogen follicles were the dominant effects in women. Thickening of miniaturized hair and regrowth of dormant telogen follicles contributed equally to the increased TH seen in men (see Graphical Abstract).

摘要

引言

ALRV5XR治疗雄激素性脱发(AGA)和休止期脱发(TE)的早期证据表明,该药物可使男女头皮毛发恢复正常表型。

设计

我们进行了两项为期24周的双盲安慰剂对照比较试验,男女各一项,以研究ALRV5XR对92例AGA患者(其中24例也患有TE)的AGA和TE毛发再生的治疗效果。46名女性(年龄24 - 64岁)和46名男性(年龄22 - 63岁)被1:1随机分配接受ALRV5XR或安慰剂治疗方案(每日两次口服胶囊以及每日使用洗发水、护发素和毛囊血清)。

评估

终毛(TH)密度的绝对和相对变化;反应率、毳毛(VH)密度变化、TH/VH比值、毛发直径、生长速度和脱落率。

结果

41名女性(20名接受ALRV5XR,2I名接受安慰剂)和36名男性(17名接受ALRV5XR,19名接受安慰剂)完成了试验。18名女性和21名女性、11名男性和11名男性(分别为接受ALRV5XR、安慰剂治疗)的TH结果可评估。女性的疗效:30.1根TH/cm(P = 0.0002),增长19.7%(P = 0.0016)。男性的疗效:21.0根TH/cm(P = 0.0014),增长16.4%(P = 0.0012)。66.7%的女性和100%的男性对ALRV5XR有反应。男性的TH/VH比值增加了33.0%(P = 0.0033)。女性的生长速度增加了3o.7μm/24小时(P < 0.0001),增长10.0%(P < 0.0001)。未报告不良事件。

结论及意义

ALRV5XR可显著促进TH再生。在女性中,激活休眠期毛囊加速再生是主要作用。男性中,微型化毛发变粗和休眠期毛囊再生对TH增加的作用相当(见图1)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/45b626ec8823/fmed-09-918058-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/42e38e92de17/fmed-09-918058-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/32f7ff7800af/fmed-09-918058-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/45b626ec8823/fmed-09-918058-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/42e38e92de17/fmed-09-918058-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/32f7ff7800af/fmed-09-918058-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c6/9421616/45b626ec8823/fmed-09-918058-g003.jpg

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