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含 L.f(柚木)叶提取物的生发配方的有效性和安全性:一项针对男性雄激素性脱发的随机、双盲、安慰剂对照研究。

Effectiveness and Safety of Hair Growth Formulation Containing L.f (Teak) Leaf Extract: A Randomized, Double-Blind, Placebo-Controlled Study on Males with Androgenic Alopecia.

机构信息

Center of Excellence for Natural Health Product Innovation, Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.

Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Center of Excellence for Innovation in Chemistry, Naresuan University, Phitsanulok, Thailand.

出版信息

J Evid Based Integr Med. 2024 Jan-Dec;29:2515690X241291141. doi: 10.1177/2515690X241291141.

Abstract

BACKGROUND

Androgenic alopecia (AGA) is commonly known as male patterned baldness. A high level of dihydrotestosterone (DHT) plays a significant role in AGA development. Inhibition of the enzyme steroid 5-alpha reductase (S5AR), responsible for converting testosterone into DHT, has been shown to delay the progression of AGA. Teak ( L.f) leaf extract exhibited a potent S5AR inhibitory activity. To prove the effectiveness and safety of teak leaf extract as a hair growth promotor, a double-blind, randomized placebo-controlled trial was conducted.

METHODS

Eighty-one AGA subjects were randomly assigned to receive either a hair tonic containing 1% teak leaf extract (HT-teak), 5%minoxidil (positive control), or a placebo administered twice daily, for 24 weeks. Efficacy was assessed through target area hair count (TAHC), anagen-to-telogen ratio (A/T), hair shedding every 4 weeks, and patients' subjective assessments of hair regrowth were assessed at the end of the experiment. Data was analyzed using repeated measure ANOVA.

RESULTS

Both the HT-teak and minoxidil groups exhibited a significant increase in TAHC and A/T, along with a decrease in hair shedding compared to baseline values. Conversely, the placebo group showed no observable signs of hair regrowth. Furthermore, the HT-teak group reported the highest satisfaction scores, and there were no indications of skin irritation or systemic effects on sexual dysfunction and palpitation after 24 weeks of HT-teak application.

CONCLUSION

Teak leaf extract, as incorporated in HT-teak, demonstrates potential as an alternative mild hair growth promoter for individuals with AGA, offering both efficacy and safety.

TRIAL REGISTRATION

This study was retrospectively registered on International Standard Randomised Controlled Trial Number (ISRCTN.com); ISRCTN24541842 (registered on January 8, 2024).

摘要

背景

雄激素性脱发(AGA)通常被称为男性型秃发。高水平的二氢睾酮(DHT)在 AGA 发展中起着重要作用。抑制负责将睾酮转化为 DHT 的酶 5α-还原酶(S5AR)已被证明可延缓 AGA 的进展。柚木( L.f)叶提取物表现出很强的 S5AR 抑制活性。为了证明柚木叶提取物作为毛发生长促进剂的有效性和安全性,进行了一项双盲、随机、安慰剂对照试验。

方法

81 例 AGA 受试者随机分为接受含有 1%柚木叶提取物的生发香波(HT-teak)、5%米诺地尔(阳性对照)或安慰剂,每日两次,共 24 周。通过靶区毛发计数(TAHC)、生长期-休止期比(A/T)、每 4 周的脱发情况以及实验结束时患者对头发再生的主观评估来评估疗效。数据采用重复测量方差分析进行分析。

结果

HT-teak 和米诺地尔组的 TAHC 和 A/T 均显著增加,与基线值相比脱发减少。相反,安慰剂组没有观察到头发再生的迹象。此外,HT-teak 组报告的满意度评分最高,并且在 HT-teak 应用 24 周后没有皮肤刺激或全身性影响性功能和心悸的迹象。

结论

柚木叶提取物作为 HT-teak 的一部分,具有作为 AGA 个体替代温和毛发生长促进剂的潜力,具有疗效和安全性。

试验注册

本研究在国际标准随机对照试验编号(ISRCTN.com)上进行了回顾性登记;ISRCTN24541842(2024 年 1 月 8 日登记)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef1a/11612263/1bfbd7510598/10.1177_2515690X241291141-fig1.jpg

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