Evaluation of the Benefits of a Cosmetic Anti-hair Loss Lotion Applied in Combination With Finasteride in Male Subjects With Hair Loss: Investigator-blinded, Randomized, Multi-center Study Performed Under Dermatological Control

Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. In men, hair loss typically involves the temporal and vertex region while sparing the occipital region: the characteristic "horseshoe" pattern. Incidence and prevalence of AGA depend on age and race.
Vichy has developed a new cosmetic anti hair loss lotion with the aim of acting on androgenic alopecia. The aim is to improve the efficacy on hair loss of the association of the lotion with finasteride versus finasteride alone.
The primary objective of this investigator-blinded, randomized multi-center study is to quantitatively evaluate, using the phototrichogram method, the efficacy of a lotion associated with finasteride versus finasteride alone on hair growth parameters in male subjects with androgenetic alopecia.

开始日期2024-11-02

申办/合作机构

Cosmetique Active International

[+2]

TCTR20240926001 / Not yet recruiting临床3期IIT

Efficacy and safety of different doses of topical finasteride in the treatment of male androgenetic alopecia

开始日期2024-09-30

申办/合作机构-

NCT06233227 / Not yet recruiting临床1期

A Bioequivalence Study of Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule in Healthy Thai Male Volunteers Under Fasting Condition

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses.

开始日期2024-09-24

申办/合作机构

Bio-innova Co., Ltd

100 项与 5α-reductase 相关的临床结果

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100 项与 5α-reductase 相关的转化医学

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0 项与 5α-reductase 相关的专利（医药）

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项与 5α-reductase 相关的文献（医药）

2025-01-01·Comparative Biochemistry and Physiology Part C: Toxicology & Pharmacology

Effects of 5α-reductase inhibition by dutasteride on reproductive gene expression and hormonal responses in zebrafish embryos

Article

作者: Kim, Young Jun ; Adnan, Karim Md ; Park, Chang Gyun ; Lee, Sang-Ah ; Ryu, Chang Seon ; Jun, Indong ; Cho, Hyunki ; Yoon, Juyong

Steroid 5α-reductase (SRD5A) is a crucial enzyme involved in steroid metabolism, primarily converting testosterone to dihydrotestosterone (DHT). Dutasteride, an inhibitor of SRD5A types 1 and 2, is widely used for treating benign prostatic hyperplasia. An adverse outcome pathway (AOP) has been documented wherein SRD5A inhibition decreases DHT synthesis, leading to reduced levels of 17β-estradiol (E2) and vitellogenin (VTG), subsequently impairing fecundity in fish (AOP 289). However, the molecular and cellular mechanisms underlying these effects remain poorly understood. In this study, we assessed the impact of SRD5A inhibition on zebrafish embryos (Danio rerio). Exposure to dutasteride resulted in decreased DHT, E2, and VTG levels, showing a positive correlation. Dutasteride also downregulated the expression of reproduction-related genes (srd5a2, cyp19a1, esr1, esr2a, esr2b, and vtg), with interrelated reductions observed across these levels. Docking studies suggested that dutasteride's effects may operate independently of androgen receptor (AR) and estrogen receptor (ER) interactions. Furthermore, co-exposure of dutasteride (0.5 or 2 μM) with 0.5 μM DHT revealed gene expression levels comparable to the control group. These findings underscore DHT's pivotal role in modulating estrogenic function and the interplay between estrogenic and androgenic responses in vertebrates. Our proposed AOP model offers insights into mechanistic gaps, thereby enhancing current understanding and bridging knowledge disparities.

2025-01-01·Journal of Ethnopharmacology

Terminalia bellirica (Gaertn.) Roxb. Extracts reshape the perifollicular microenvironment and regulate the MAPK pathway for androgenetic alopecia treatment

Article

作者: Jiang, Lining ; Xiang, Hong ; Ni, Rui ; Zhang, Yu ; Chen, Jianhong ; Li, Jiaming ; Liu, Yao ; Li, Ziwei ; Li, Li ; Peng, Dan

ETHNOPHARMACOLOGICAL RELEVANCETerminalia bellirica (Gaertn.) Roxb. (TBR), a popular herbal remedy in India and Southeast Asia, has been demonstrated to possess multiple pharmacological activities. However, systematic studies on the medicinal effects and mechanism of TBR for the androgenetic alopecia (AGA) treatment are deficient.MATERIALS AND METHODSHuman Umbilical Vein Endothelial Cells (HUVECs) and testosterone-induced AGA mice were used to evaluate the hair regrowth activity of TBR extracts. Chemical constituents and potential active components of TBR extracts were analyed by UPLC-Q-TOF-MS in vitro/vivo. The hair regrowth mechanisms of TBR were elucidated through network pharmacology and experimental validation.RESULTSTotally 28 chemical constituents in TBR were identified, of which 15 were predicted as potential active components for AGA therapy. TBR could significantly scavenge ROS, promote VEGF level/cell migration of HUVECs, and inhibiting type II 5α-reductase activity (the inhibit rate: 82.35 ± 1.02 %). Pharmacodynamic evaluation suggested that TBR effectively led to hair regrowth in C57BL6 mice compared to minoxidil. TBR promoted the hair follicle (HF) transition from the telogen phase to anagen phase by decreasing MDA levels, increasing VEFG expression and up-regulating phosphorylated P38/ERK protein levels in the MAPK signalling pathway.CONCLUSIONSTBR reversed AGA via inhibiting SRD5A2 activity and stimulating the MAPK pathway. Meantime, TBR could remodel the follicle microenvironment by reducing oxidative stress and increasing angiogenesis.

2025-01-01·Theriogenology

Paternal trans fatty acid and vitamin E diet affect the expression pattern of androgen signaling pathway genes in the testis of rat offspring

Article

作者: Shams, Amir Abbas ; Alizadeh, AliReza ; Karoii, Danial Hashemi ; Vesali, Samira ; Shahhoseini, Maryam ; Vesal, Soheil

Numerous studies have shown that an improper diet in parents has a negative impact on offspring's health. Furthermore, the negative effects of trans fatty acids (TFA) in maternal diets on fertility and health and their impact on future generations have been documented. However, there is limited research on the negative effects of TFA in paternal diets on male children. The current work used qRT-PCR to investigate the effects of trans fatty acids and vitamin E in the paternal diet on the expression pattern of androgen signaling pathway genes such as STAR, CYP11a1, HSD3B, SRD5a2, and SCARB1 in offspring testes. In this experiment, parental rats were randomly separated into four groups, each with ten father rats, and were fed for eight weeks (60 days) as follows. 1: Standard diet group plus liquid sunflower oil (control). 2: Standard diet group containing trans fatty acids (CTH). 3: The regular diet group received 2.5 times the recommended quantity of vitamin E supplement. 4: Standard diet group with vitamin E and trans fatty acid supplementation (ETH). The testis tissue samples from 35 offspring were then used. Following RNA extraction from tissues and cDNA synthesis, quantitative real-time PCR was used to evaluate the expression levels of androgen signaling pathway genes such as STAR, CYP11A1, HSD3B, SCARB1, and SRD5A2. Our findings showed that the expression of CYP11A1 was considerably reduced in the progeny of paternal rats given ETH compared to the CTH group. The expression levels of the STAR gene were significantly lower in the progeny of paternal rats administered TFA, ETH, and vitamin E compared to the controls. Although the CTH group had lower SCARB1 expression than the other groups, the difference was not statistically significant. Paternal vitamin E consumption substantially affected SRD5A2 expression when compared to offspring of paternal rats fed vitamin E + trans fatty acid or those fed a conventional diet containing trans fatty acid. Furthermore, the vitamin E group showed a statistically significant increase in HSD3B expression compared to the other groups. Bioinformatics analyses, such as protein-protein interaction networks and gene ontology term enrichment, revealed that these genes play roles in lipid biosynthesis, hormone metabolism, male sex differentiation, reproductive development, and steroid biosynthesis. Our data indicate that paternal trans fatty acid consumption influences the expression of particular androgen signaling pathway genes in offspring testis, with vitamin E potentially mitigating some of these effects.

项与 5α-reductase 相关的新闻（医药）

2024-08-14

·药融圈

来自苏州，德亘生物首个口服双靶点PROTAC药物DG01获临床默示许可

▲8月15-16日2024生物医药创新者峰会扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。 2024年8月2日，苏州德亘生物医药有限公司自主研发的首个口服双靶点PROTAC药物DG01经过CDE专家科学严谨的审评，顺利获得国家药监局的临床默示许可批件。DG01拟用于用于晚期或转移性趋势抵抗性前列腺癌和肝癌等实体肿瘤的治疗。从德亘生物公开的专利CN117801051A来看，DG01应为低分子量双降解机制的药物，同时降解GSPT1和SRD5A3靶蛋白，双降解的作用机制诱导雄激素受体（AR）和AR-V7的下调，从而抑制前列腺癌细胞的增殖，达到治疗前列腺癌的效果。WB试验C59化合物有着皮摩尔（pM）的GSPT1和SRD5A3降解活性，体外细胞试验显示，部分细胞系抑制活性达到pM级别，体内动物药效试验显示，小鼠口服C63化合物能完全抑制前列腺癌细胞系22Rv1肿瘤增殖。目前，靶向降解GSPT1进入临床阶段到药物全球有三家公司的管线：1、美国Monte Rosa公司用于治疗实体瘤的分子胶药物MRT-2359正在进行Ⅰ期临床试验，今年四月AACR公开了其前列腺癌的早期研究数据，并新增了临床扩展MRT-2359和恩杂鲁胺联用治疗前列腺癌。2、中国成都分迪药业用于治疗血液瘤（急性髓系白血病AML、多发性骨髓瘤MM和非霍奇金淋巴瘤NHL）的分子胶药物FD-001正在华西医院血液内科进行Ⅰ期临床试验。3、美国BMS公司用于治疗急性髓系白血病的分子胶-抗体偶联药物BMS-986497/ORM-6151正在进行Ⅰ期临床试验。德亘生物的DG01是全球范围内首次获批临床的口服靶向GSPT1和SRD5A3降解的PROTAC药物，用于治疗实体瘤中的前列腺癌和肝癌。 ▎关于苏州德亘生物苏州德亘生物医药有限公司是2018年7月在苏州工业园区成立的一家专注于靶向蛋白降解的公司，目前公开专利较少，融资情况未见报道。经天眼查，公司股东为杭州企创化工、杭州普雷化工、上海拓莱化学实控人以及几位自然人。版权声明：本文转自药融圈info，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 8月15日 B馆B103 XDC领域的差异化创新和国际化策略大会主席：夏明德，英诺湖医药，CEO&董事长会议日程主持人：夏明德，英诺湖医药，CEO&董事长 08:55-09:00 大会主席致辞夏明德｜英诺湖医药，CEO&董事长 09:00-09:20 ADC FIC 药物因CMC的生产缺陷导致批准上市延缓的启示刘翠华｜百奥泰生物，高级副总裁 09:20-09:40 小型多肽类及双靶向偶联药物的研究、临床开发进展和成药展望邵军｜同宜医药，首席技术官 09:40-10:00 宜联生物TMALIN ADC技术平台：提高药效、在新空间寻找靶蔡家强｜宜联生物，联合创始人&CSO 10:00-10:20 MIDD视角下的ADC药物开发苏霞｜康龙化成，临床药理&定量药理高级总监 10:20-10:40 未来已来：端到端的创新ADC药物发现与商业化开发模式秦刚｜启德医药，CEO 10:40-11:00 核药临床试验设计的特殊性与实施的挑战刘艳｜米度生物，首席医学官 11:00-11:20 ADC的组合创新谢雨礼｜上海微境生物，创始人&总经理 11:20-12:00 圆桌：如何从早期设计降低XDC的临床失败？ 1.XDC从早期设计到临床开发成败案例 2.失败的原因分析 3.从失败的案例中可以得到哪些启发？如何避免主持人：夏明德｜英诺湖医药，CEO&董事长刘翠华｜百奥泰生物高级副总裁邵军｜同宜医药，COO 蔡家强｜宜联生物，CSO 秦刚｜启德医药，CEO 肖志华｜奥浦迈，董事长 1200-1330 午餐主持人：刘艳，米度生物，首席医学官 13:30-13:50 生命科学前沿应用之ADC药物研发徐雍羽｜瑞孚迪，类器官和生物制药项目经理 13:50-14:10 New Drug Modality在未被满足临床上的探索--放射性偶联药物单波｜博锐创合，CEO 14:10-14:30 创新核药研发与产业链之诺宇解决方案方鹏｜诺宇医药，董事长&创始人 14:30-14:50 靶向Nectin4核素偶联药物的开发习宁｜范恩柯尔，创始人&CEO 14:50-15:10 核药产业发展现状邓启民｜成都云克药业，总经理 15:10-15:30 靶向GPC3放射性药物的筛选与开发宋征｜艾博兹医药，临床前开发副总裁 15:30-15:50 核素药物全球化专利布局挑战与策略唐华东｜植德律所，合伙人扫码报名参会【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

抗体药物偶联物蛋白降解靶向嵌合体临床1期临床结果AACR会议

2024-06-20

·BioSpace

Prostate Drugs May Find New Use in Reducing Risk of Dementia: Study

Pictured: Concept art showing an elderly woman overlaid with an illustration of a brain/iStock, boonstudio Drugs commonly used for the treatment of enlarged prostate may also help lower the risk of dementia with Lewy bodies, according to a new observational study from the University of Iowa Health Care. Drawing from Merative MarketScan, one of the largest proprietary U.S. healthcare claims databases, University of Iowa researchers identified more than 643,000 men who were starting treatment for benign prostatic hyperplasia with one of six common therapies. Three of these drugs fell under the class of α-1 adrenergic receptor antagonists, better known as α-blockers, which work by inhibiting the contraction of smooth muscles. The researchers focused on terazosin, which is sold by Abbott under the brand name Hytrin, doxazosin, which is marketed by Pfizer as Cardura, and alfuzosin, which is branded as Uroxatral by Sanofi. Alpha-blocker drugs are known to have a unique side effect: they activate a key enzyme involved in the production of ATP, which is the molecular form of cellular energy. In the brain, these drugs can help boost the production of energy and fight neurodegeneration, the University of Iowa scientists hypothesized. As active comparators, the researchers also followed men in Merative MarketScan who were being treated with tamsulosin or with the 5α-reductase inhibitors (5ARI) finasteride and dutasteride, all of which are not known to affect energy production in the brain. The men included in the study had no history of dementia with Lewy bodies (DLB). Participants were then followed until they exited the database or until they developed DLB. After an average follow-up of around three years, the study found that men who were initiated on the three alpha-blocker drugs were 40% less likely to develop DLB than comparators who were on tamsulosin. Compared with men whose enlarged prostates were being treated with 5ARI agents, the risk of DLBA was 27% lower in those taking alpha-blocker drugs. Both effects were statistically significant. By contrast, DLB had a statistically similar likelihood of developing in men being managed with tamsulosin and 5ARIs. These results were robust to several sensitivity analyses, according to researchers. The University of Iowa scientists published their findings Wednesday in Neurology, the medical journal of the American Academy of Neurology. “If terazosin and these similar medications can help slow this progression—if not outright preventing the disease—this would be important to preserving cognitive function and quality of life in people with DLB,” Jacob Simmering, assistant professor of internal medicine at the University of Iowa and lead study author, said in a statement. However, the researchers caution that the study is simply observational in design and only shows that there is a statistical correlation between the use of alpha-blocker drugs and the reduced risk of DLB. It does not establish causation nor does it show any directionality of association, they said. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

临床结果

2024-06-19

·drugs

Dementia With Lewy Bodies Risk Down With α-1 Adrenergic Receptor Antagonists

WEDNESDAY, June 19, 2024 -- Men taking α-1 adrenergic receptor antagonists terazosin, doxazosin, and alfuzosin (Tz/Dz/Az) seem to have a lower risk for dementia with Lewy bodies (DLB), according to a study published online June 19 in Neurology . Alexander Hart, M.D., M.P.H., from the University of Michigan in Ann Arbor, and colleagues used a new-user active comparator design in the Merative Marketscan database to identify men with no history of DLB who were newly initiated on Tz/Dz/Az or two comparator medications (α-1 adrenergic receptor antagonist tamsulosin or 5α-reductase inhibitor [5ARI]) to examine the potential neuroprotective effects of Tz/Dz/Az. The researchers found that the risk for developing DLB was lower for men who were newly started on Tz/Dz/Az than those taking tamsulosin or 5ARI (hazard ratios, 0.60 and 0.73, respectively), while the risk was similar for men taking tamsulosin versus 5ARI. The results were robust to sensitivity analyses. "More research is needed to follow people over time and determine whether there is a cause-and-effect relationship here, but it is promising to think that these drugs could have a protective effect on this disease that will likely affect a larger number of people as the population ages," coauthor Jacob E. Simmering, Ph.D., of the University of Iowa in Iowa City, said in a statement.

临床结果