Article

Evaluation of efficacy and safety of finasteride 1 mg in 3177 Japanese men with androgenetic alopecia

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Abstract

Before now, there has been no study of finasteride use exceeding 1 year in Japanese men with androgenetic alopecia (AGA) except the study subsequently conducted from the development phase. Since the launch of finasteride, no study in a larger population had been reported. Ethnic variation of the onset age, progressive nature and degree of hair loss of androgenetic alopecia are known. The therapeutic effect of oral finasteride (Propecia) was examined on androgenetic alopecia of Japanese men. The efficacy and safety of finasteride (1 mg tablet) was evaluated in Japanese men with AGA in the long term. The study enrolled 3177 men given finasteride 1 mg/day from January 2006 to June 2009 at our clinic. Efficacy was evaluated in 2561 men by the modified global photographic assessment; the photographs were assessed using the standardized 7-point rating scale. Safety data were assessed by interviews and laboratory tests in all men enrolled in the study. The overall effect of hair growth was seen in 2230 of 2561 men (87.1%), in whom hair greatly (11.1%), moderately (36.5%) and slightly (39.5%) increased. The response rate improved with increasing duration of treatment. Adverse reactions occurred in 0.7% (23/3177) of men; seven men discontinued treatment based on risk-benefit considerations. No specific safety problems associated with long-term use were observed. This study represents data collected at a single institution. Many patients did not receive follow-up examination. In Japanese men with AGA, oral finasteride used in the long-term study maintained progressive hair regrowth without recognized side-effect.

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... Dihydro-testosterone (DHT) has a key role in mediating progressive scalp hair loss in men with AGA, and finasteride blocks the conversion of testosterone to DHT as a selective type II 5α-reductase inhibitor, which justifies its use in AGA treatment [1][2][3]. Although the efficacy of AGA treatment with finasteride has been demonstrated by several large-scale and long-term studies, [4][5][6][7] no long-term investigation for up to 10 years has yet been conducted in Japanese subjects [8][9][10]. Therefore, the objective of this study was to evaluate the efficacy and safety of large-scale and long-term AGA treatment with finasteride, which, to our knowledge, is the first of such studies in Japan. ...
... A high objective efficacy was demonstrated by the MGPA, which revealed improvement and prevention of disease progression in 99.1% of the 532 Japanese men with AGA treated with 1 mg/day finasteride for 10 years. Furthermore, the outcome was similar to or better than that reported by other studies in Japan [8][9][10]13,17]. Differences have been known to occur in the progression of AGA symptoms between Japanese and Caucasian men [8,18]. ...
... Furthermore, the outcome was similar to or better than that reported by other studies in Japan [8][9][10]13,17]. Differences have been known to occur in the progression of AGA symptoms between Japanese and Caucasian men [8,18]. This efficacy of the investigated treatment in Japanese men exceeded that reported in other studies in Caucasians. ...
... in temporal region, resulting in a gradual decrease in the hair diameter [1] . ...
... Exposure of skin to surfactants may induce irritation, but in our case this fact was also not observed. The type and degree surfactant irritancy can be related to the type and concentration and also some other factors such as skin type, color, and age [1,32,51] . ...
Article
Background/aims: Androgenetic alopecia is an extremely common dermatological disorder affecting both men and women. Oral finasteride (FNS), a synthetic 4-aza-3-oxosteroid compound with poor aqueous solubility, blocks the peripheral conversion of testosterone to dihydrotestosterone (DHT) in a significant reduction in DHT concentration, achieving satisfactory results in alopecia treatment. However, its oral intake generally causes severe side effects. Considering that there is currently no scientifically proven treatment, new drug delivery systems able to improve alopecia therapy are urgently required. Methods: In this study, polymeric nanoparticles have been proposed as a new carrier for topical delivery of FNS in hair follicles. Results and conclusions: Polymeric nanoparticles, prepared by using a modified method of the emulsification/solvent diffusion, showed a mean particle size around 300 nm, which may be sufficient for reaching the dermis and hair follicles and negative zeta potential values. Scanning electron microscope measurements showed that all the polymeric nanoparticles exhibited a spherical shape and a smooth surface regardless of their composition. A high encapsulation efficiency was achieved for FNS (79.49 ± 0.47%). In vitro release assays in physiological conditions demonstrated that nanoparticles yielded a prolonged release of FNS for 3 h. Skin assays through an in vitro permeation study demonstrated that nanoparticles had low levels of penetration of FNS, improving its time residence onto the skin. All excipients used in nanoparticle composition and in 3 different vehicles were safe. These results suggest that the proposed novel formulation presents several good characteristics indicating its suitability for dermal delivery of FNS for alopecia treatment.
... The efficacy of finasteride has been rated as level of evidence 1 [23][24][25][26][27]. Based on clinical trials, the dose stracyjnymi, ale w większości przypadków opiera się to na dobrze udokumentowanej wiedzy medycznej. ...
... Dowody na efektywność terapii finasterydem oceniono na poziom pierwszy [23][24][25][26][27]. Na podstawie badań klinicznych wyznaczono dawkę 1 mg jako skuteczną w leczeniu łysienia androgenowego mężczyzn i w takiej dawce zarejestrowano lek w tym wskazaniu. ...
Article
Full-text available
The main pathogenetic process in androgenetic alopecia is dihydrotestosterone-mediated follicular miniaturization in androgen-dependent scalp areas. Differential diagnosis is complex, especially in women, and covers a broad spectrum of non-cicatricial and cicatricial alopecias, particularly telogen effluvium and frontal fibrosing alopecia. The basic additional diagnostic procedure is trichoscopy. Currently there are two drugs approved for the treatment of androgenetic alopecia: minoxidil (in men and women) and finasteride (in men). However, medical literature indicates significantly more therapeutic options. The article presents algorithms recommended for the management of androgenetic alopecia in women and men.
... Moreover, treatment was discontinued due to sexual side effects only in 4% of patients [48]. Further, a study on 3177 Japanese patients treated with small doses of finasteride for 41 months failed to reveal any sexual side effects [49]. ...
Article
Full-text available
nhibitors of 5α-steroid reductase are drugs used to treat androgen-dependent conditions including prostate diseases and androgenic alopecia. Finasteride was the first on the market and is currently the most widely used inhibitor. Dutasteride was the second inhibitor to be approved and has a similar safety profile. Common adverse events of treatment consist of sexual disorders and a negative affect balance. It was described that the prolonged use of 5α-steroid reductase inhibitors in patients with alopecia can cause persistent side effects called a post-finasteride syndrome (PFS), that is not just a simple coexistence of events, but rather a definite syndrome with an iatrogenic background. PFS occurs in susceptible individuals even after small doses of the drug and can last for a long time after the discontinuation of treatment. A deterioration in the quality of life in affected individuals does not justify use of the drug. Wider recognition of PFS symptoms, its incidence, course, prevention, and treatment possibilities will allow the indications for drug use to be reconsidered and treatment to be more personalized. Knowledge about PFS will also help to provide the best treatment for affected individuals and to properly educate patients before obtaining an informed consent for therapy with 5α-steroid reductase inhibitors.
... As expected, several studies have demonstrated that 1mg oral finasteride daily is effective in prevention and treatment of MPB. In the most recent study published in 2012, Sato and Takeda reported on efficacy and safety of 1mg oral finasteride for treatment of MPB in the so far largest population study of enrolled 3'177 Japanese men treated with oral finasteride at the Tokyo Memorial Clinic Hirayama Department of Plastic and Aesthetic Surgery, School of Medicine, Kitasato University, Tokyo, Japan [2]: Efficacy was evaluated by global photographic assessment, and safety data were assessed by interviews and laboratory tests. The overall effect on hair growth was seen 87.1%, in whom hair increased greatly in 11.1%, moderately in 36.5%, and slightly in 39.5%. ...
Article
Based on observations of Julianne Imperato-McGinley of Cornell Medical College, New York presented at a conference on birth defects in 1974 on a peculiar genetic disorder due to type 2 5α-reductase deficiency (5-ARD), oral finasteride was approved in 1992 by the U.S. Food and Drug Administration for treatment of benign prostatic hyperplasia (BPH), and in 1997 for treatment of male pattern baldness (MPB). This article is protected by copyright. All rights reserved.
... Oral finasteride (1mg/day) has been approved by the United States of America Food and Drug Administration since December 1997 for the treatment of AGA in males. Finasteride is a type II 5-alpha reductase (5AR) inhibitor (5ARI), which significantly improves hair growth, [1] slows hair loss when compared with placebo, [2][3][4] and is a very commonly used treatment for AGA. In a study by Jung et al, [5] vertex hair in men with AGA presented improvement in only 48% of patients after 1 year and in only 66% at the end of 2 years when treated with finasteride 1 mg/day. ...
Article
Full-text available
Background: Finasteride and dutasteride are inhibitors of the enzyme 5-alpha-reductase which inhibits the conversion of testosterone to dihydrotestosterone. Dutasteride inhibits both type I and type II 5-alpha-reductase while finasteride inhibits only the type II enzyme. As both isoenzymes are present in hair follicles, it is likely that dutasteride is more effective than finasteride. Aims: To compare the efficacy, safety and tolerability of dutasteride and finasteride in men with androgenetic alopecia. Methods: Men with androgenetic alopecia between 18 and 40 years of age were randomized to receive 0.5 mg dutasteride or 1 mg finasteride daily for 24 weeks. The primary efficacy variables were hair counts (thick and thin) in the target area from modified phototrichograms and global photography evaluation by blinded and non-blinded investigators. The secondary efficacy variable was subjective assessment using a preset questionnaire. Patients were assessed monthly for side effects. Results: Ninety men with androgenetic alopecia were recruited. The increase in total hair count per cm 2 representing new growth was significantly higher in dutasteride group (baseline- 223 hair; at 24 weeks- 246 hair) compared to finasteride group (baseline- 227 hair; at 24 weeks- 231 hair). The decrease in thin hair count per cm 2 suggestive of reversal of miniaturization was significantly higher in dutasteride group (baseline- 65 hair; at 24 weeks- 57 hair) compared to finasteride group (baseline- 67 hair; at 24 weeks- 66 hair). Both the groups showed a similar side effect profile with sexual dysfunction being the most common and reversible side effect. Limitations: Limitations include the short duration of the study (6 months), the small sample size and the fact that it was an open-label study. Conclusions: Dutasteride was shown to be more efficacious than finasteride and the side-effect profiles were comparable.
... Oral finasteride (1mg/day) has been approved by the United States of America Food and Drug Administration since December 1997 for the treatment of AGA in males. Finasteride is a type II 5-alpha reductase (5AR) inhibitor (5ARI), which significantly improves hair growth, [1] slows hair loss when compared with placebo, [2][3][4] and is a very commonly used treatment for AGA. In a study by Jung et al, [5] vertex hair in men with AGA presented improvement in only 48% of patients after 1 year and in only 66% at the end of 2 years when treated with finasteride 1 mg/day. ...
... Efficacymales Finasteride Twenty-five studies investigating the efficacy of finasteride in male patients with AGA met the inclusion criteria of the guideline. 34,35,38,41,44,[67][68][69][70][71][72][73][74][75][76][77][78][79][80][81][82][83][84][85][86] Thirteen studies obtained grade A2 evidence, nine grade B and three grade C. Fourteen studies were placebo-controlled. An EVIDENCE LEVEL 1 can be attributed. ...
Article
Androgenetic alopecia is the most common hair loss disorder, affecting both men and women. Initial signs of androgenetic alopecia usually develop during teenage years leading to progressive hair loss with a pattern distribution. Moreover, its frequency increases with age and affects up to 80% Caucasian men and 42% of women. Patients afflicted with androgenetic alopecia may undergo significant impairment of quality of life. The European Dermatology Forum (EDF) initiated a project to develop evidence-based guidelines for the treatment of androgenetic alopecia. Based on a systematic literature research the efficacy of the currently available therapeutic options was assessed and therapeutic recommendations were passed in a consensus conference. The purpose of the guideline is to provide dermatologists with an evidence-based tool for choosing an efficacious and safe therapy for patients with androgenetic alopecia.
... Finasteride converts miniaturized hair follicles into terminal hairs and elongates the anagen phase of the hair follicle. It is most effective for treating vertex thinning, but also it works on the frontal area [1][2][3][4][5]. ...
Chapter
The key change of androgenetic alopecia (AGA) is the thinning of hairs caused by miniaturization of hair follicles, not the shedding of hairs. As terminology implies, androgens (male sex hormones), especially dihydrotestosterone (DHT), play important roles in the pathogenesis of AGA, but no exact pathogenesis has been proven so far. However, several medications are successfully used for AGA through various mechanisms.
... Clinical studies have demonstrated both a high efficacy of treatment and a favorable safety profile [3][4][5][6][7][8][9][10], establishing the drug as the first-line treatment of MPHL. In 2012, Sato and Takeda [11] reported on efficacy and safety of 1 mg oral finasteride for treatment of MPHL in the so far largest population study of enrolled 3,177 Japanese men. The overall effect on hair growth was seen in 87.1%, in whom hair increased greatly in 11.1%, moderately in 36.5%, and slightly in 39.5%. ...
Article
Oral finasteride represented a breakthrough for treatment of male pattern hair loss (MPHL), with clinical studies having demonstrated high efficacy of treatment and a favorable safety profile. And yet, fertility issues, malignancy, and postfinasteride syndrome have been concerns of users and prescribers of the drug. Pre-existing mental health disorder may put patients at an increased risk of nocebo, while the prevalence of personality disorders in subjects with MPHL is known to be higher than in the general population, specifically histrionic personality disorder. We devised a system for patient selection and risk assessment, including fertility issues, regular PSA determinations, and specific mental health assessment. For those who choose regular prostate cancer screening, the use of finasteride meaningfully reduces the risk of prostate cancer. While gynecomastia is a known, rare adverse effect of finasteride, so far, studies support the view that exposure to finasteride is not associated with male breast cancer risk. Patient understanding and involvement are central to optimal treatment selection and active patient role in treatment.
... This medication is the only drug approved by the Food and Drug Administration to specifically stop hair loss, and has been shown to be 90% effective in preventing ongoing male pattern hair loss in the crown. [8][9][10] In clinical practice it is not uncommon to see this same salutary effect in the frontal scalp as well as in the NPA. Dr Umar also cites several other limitations to the study design. ...
... of the targeted hair. 6,7 Observing related literature on the effectiveness of finasteride in AGA, as many as 30%-45% of participants did not show relief of clinical symptoms which were eventually hard to control. 8 Although hair above the head is no longer shed after the treatment of finasteride, patient's target for treatment is not only to delay the progression of AGA, but also to increase the amount of the targeted hair and improve patients' quality of life. ...
Article
Full-text available
Aim We performed a meta-analysis to evaluate the efficacy and safety of dutasteride and finasteride in treating men with androgenetic alopecia (AGA) during a 24-week treatment cycle. Methods Randomized controlled trials of dutasteride and finasteride for treating AGA were searched using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The data were calculated using Rev Man v5.3.0. The reference lists of retrieved studies were also investigated. Results Three articles including 576 participants which compared dutasteride with finasteride were selected for our analysis. The mean change in total hair count (mean difference [MD], 28.57; 95% CI, 18.75–38.39; P<0.00001), investigator’s assessment of global photographs for the vertex (MD, 0.68; 95% CI, 0.13–1.23; P=0.02) and frontal (MD, 0.63; 95% CI, 0.13–1.13; P=0.01) views, panel global photographic assessment for the vertex (MD, 0.17; 95% CI, 0.09–0.24; P<0.00001) and frontal (MD, 0.25; 95% CI, 0.18–0.31; P<0.00001) views, and subjects’ assessment (MD, 0.56; 95% CI, 0.18–0.94; P=0.003) suggested that dutasteride provided a better efficacy in treating men with AGA compared with finasteride. With regard to the assessment of safety, altered libido (P=0.54), erectile dysfunction (P=0.07), and ejaculation disorders (P=0.58), dutasteride did not show a significant difference compared with finasteride. Conclusion Dutasteride seems to provide a better efficacy compared with finasteride in treating AGA. The two drugs appear to show similar rates of adverse reactions, especially in sexual dysfunction.
... Moreover, dermatologists frequently use 1 mg finasteride daily in the chronic therapy of prematurely balding young men (AGA; androgenetic alopecia) [12]. It has been postulated that long-term finasteride therapy, often lasting for many years, has no negative influence on androgen-dependent processes such as fertility or libido [13,14]. However, many studies have documented contrary findings [15,16]. ...
Article
Full-text available
Introduction: The hormone-dependent events that occur throughout the first wave of spermatogenesis, such as the establishment of the number of Sertoli cells (SCs) and spermatogonial stem cells (SSCs) within the seminiferous cords and the setting up of the blood-testis barrier, are important for adult male fertility. Any changes in the T/DHT ratio can result in male subfertility or even infertility. In this study we aimed to evaluate effects of paternal exposure to 5-alpha reductase type 2 inhibitor, finasteride on litter size, androgen levels and germ cell apoptosis in male offspring during postnatal development. Material and methods: The subjects of the study were 7, 14, 21/22, 28, and 90-day-old Wistar male rats (F1:Fin) born from females fertilized by finasteride-treated rats. Offspring born from untreated parental animals were used as a control group (F1:Control). Animals and the collected testes were weighed, blood and intratesticular levels of T and DHT were measured by ELISA, and the apoptotic index of testicular cells was evaluated by TUNEL technique. Results: We observed difficulties in obtaining male newborns from female rats fertilized by finasteride-treated male rats. In the F1:Fin rats, changes in the body and testes weights occurred, and a lower number of apoptotic cells was found during postnatal maturation of the seminiferous epithelium. Changes in androgen concentrations during the first spermatogenesis wave and adult life were also evident. Conclusion: Finasteride treatment of male adult rats may not only cause a decrease in the fertility of parental rats, but also could lead to incorrect, androgen-sensitive course of spermatogenesis in their offspring.
... The response rate increased with longer treatment. 5 However, no large-scale study on the long-term (≥5 years) effects of oral finasteride had been performed in Japan. We therefore evaluated finasteride long-term efficacy following our previous method to evaluate the difference from Caucasians. ...
Article
Finasteride is standard medical treatment for androgenetic alopecia; however, no large studies with 5 years or more of follow up have been performed in Japan. The authors followed Japanese men with androgenetic alopecia treated with finasteride for 5 years to evaluate long-term treatment efficacy. Of 903 men treated with finasteride (1 mg/day), 801 patients were evaluated over 5 years by modified global photographic assessment. Although the proportion of improvement was high (99.4%), modified global photographic assessment scores after 5 years of treatment were lower in patients with more advanced disease as measured by the modified Norwood-Hamilton scale. After separating patients into "sufficient" and "insufficient" efficacy groups according to the modified global photographic assessment score after 5 years (scores ≥6 and <6, respectively), multivariate analysis showed that independent risk factors of insufficient efficacy were age at start of treatment of 40 years or more (P = 0.021) and classification on the modified Norwood-Hamilton scale (P < 0.001), whereas presence of stress at start of treatment was a negative predictor (P = 0.025). In conclusion, continuous finasteride treatment for 5 years improved androgenetic alopecia with sustained effect among Japanese. Younger age and less advanced disease at start of treatment were the key predictors of higher finasteride efficacy. © 2015 Japanese Dermatological Association.
... Finasteride is widely used in AGA, which significantly improves hair growth and slows hair loss compared with placebo (11,29). However, finasteride is not recommended for use in women due to the risk of birth defects in women of childbearing age and its high transdermal absorption. ...
Article
Full-text available
The use of finasteride for alleviating hair loss has been investigated, and it has been applied as an oral dose medication. However, due to the inconvenience of daily drug administration over long period of time, novel controllable finasteride delivery has been actively investigated. As a novel method of finasteride delivery, the development of finasteride‑loaded microspheres for subcutaneous administration is becoming increasingly pharmaceutically important. Therefore, the present study aimed to use finasteride‑loaded microspheres in a controlled manner in an attempt to overcome the limitations of the oral administration of finasteride and to cause fewer adverse effects. Finasteride‑loaded microspheres containing poly(lactic‑co‑glycolic acid) and finasteride at a ratio of 4:1 were prepared, and a testosterone‑induced androgenic alopecia mouse model was used. Following observation for 10 weeks, the percentage hair growth was 86.7% (total hair growth 60%, partial hair growth 26.7%) in the orally‑applied finasteride‑treated group as a positive control, and 93.3% (total hair growth 60%, partial hair growth 33.3%) in the finasteride‑loaded microspheres‑treated group. Serum dihydrotestosterone levels began to decrease at week 6 in the orally‑applied finasteride‑ and finasteride‑loaded microsphere‑treated groups. In addition, the finasteride‑loaded microspheres‑treated group exhibited similar follicular number, follicular length, anagen/telogen ratio and hair bulb diameter values to those of the orally‑applied finasteride‑treated group. Furthermore, the finasteride‑loaded microspheres increased the activities of phosphoinositide 3‑kinase/protein kinase B and Wnt/β‑catenin in relation to hair follicle cell growth signaling in mouse skin, and suppressed the apoptosis of hair follicle cells by reducing the expression of transforming growth factor‑β2 and caspase‑3, which are indicators of apoptosis. In conclusion, the administration of a single injection of finasteride‑loaded microspheres was effective in treating testosterone‑induced alopecia. Furthermore, it led to equivalent hair growth effects when compared with orally‑applied finasteride, thus revealing the possibility of effective treatment via different routes of administration.
... As far as the persistence of sexual adverse events is concerned, an important finding was reported by the Medicine Health Care Products Regulatory Agency (MHRA), which, in its 2009 report states, that "... in postmarketing experience, in certain patients the ED that appeared with the introduction of Propecia is thought to persist even after discontinuation of the medicinal product". However, again on the subject of alopecia, Sato and Takeda (2012) conducted a study on the efficacy and safety of finasteride 1 mg administered for 41 months in 3177 patients with androgenetic alopecia, concluding that the treatment allowed progressive hair growth without any side effects being observed (18). In this contradictory series of data, it can be said that the nature of the persistence of these disorders is still an active field of research. ...
Article
Full-text available
Treatment-induced sexual dysfunctions (SD) are a recurrent and controversial topic in recent literature on the adverse events related to the use of 5-alpha-reductase inhibitors (5ARIs) (1, 2). In order to deal adequately with the various aspects of this topic, it is necessary to first cover some of the steps that allow a better definition and understanding of the subject.
... Moreover, treatment was discontinued due to sexual side effects only in 4% of patients [48]. Further, a study on 3177 Japanese patients treated with small doses of finasteride for 41 months failed to reveal any sexual side effects [49]. ...
Article
Inhibitors of 5α-steroid reductase are drugs used to treat androgen-dependent conditions including prostate diseases and androgenic alopecia. Finasteride was the first on the market and is currently the most widely used inhibitor. Dutasteride was the second inhibitor to be approved and has a similar safety profile. Common adverse events of treatment consist of sexual disorders and a negative affect balance. It was described that the prolonged use of 5α-steroid reductase inhibitors in patients with alopecia can cause persistent side effects called a post-finasteride syndrome (PFS), that is not just a simple coexistence of events, but rather a definite syndrome with an iatrogenic background. PFS occurs in susceptible individuals even after small doses of the drug and can last for a long time after the discontinuation of treatment. A deterioration in the quality of life in affected individuals does not justify use of the drug. Wider recognition of PFS symptoms, its incidence, course, prevention, and treatment possibilities will allow the indications for drug use to be reconsidered and treatment to be more personalized. Knowledge about PFS will also help to provide the best treatment for affected individuals and to properly educate patients before obtaining an informed consent for therapy with 5α-steroid reductase inhibitors.
... Besides, a 3.5 years study was conducted among 3177 Japanese men with AGA and was administered with oral finasteride 1 mg. 40 The efficacy of oral finasteride is ranging from 81.0% to 91.3% among grade II to V hair loss, with 91.3% patients at stage IV responded highest to the treatment. In addition, two 5 years follow-up studies were conducted among the Asian populations. ...
... Inhibition of this enzyme by finasteride [4] has found application in clinical practice-in the therapy of prostate cancer, benign prostatic hyperplasia (BPH), and androgenetic alopecia (AGA; prematurely balding young men) [5,6]. In the 1990s, finasteride was introduced to medical care and was considered a safe drug, without any "side effects" on male fertility, and this view is still maintained among dermatologists [7,8]. However, there are many studies documenting contrary findings [9,10], a decrease in semen parameters [5,11,12], difficulties in fertilization [5], psychological problems such as reduced libido, orgasms, and erectile disorders [13], melancholy, and even suicidal thoughts [14]. ...
Article
Full-text available
(1) Background: Hormone-dependent events that occur throughout spermatogenesis during postnatal testis maturation are significant for adult male fertility. Any disturbances in the T/DHT ratio in male progeny born from females fertilized by finasteride-treated male rats (F0:Fin) can result in the impairment of testicular physiology. The goal of this work was to profile the testicular transcriptome in the male filial generation (F1:Fin) from paternal F0:Fin rats. (2) Methods: The subject material for the study were testis from immature and mature male rats born from females fertilized by finasteride-treated rats. Testicular tissues from the offspring were used in microarray analyses. (3) Results: The top 10 genes having the highest and lowest fold change values were mainly those that encoded odoriferous (Olfr: 31, 331, 365, 633, 774, 814, 890, 935, 1109, 1112, 1173, 1251, 1259, 1253, 1383) and vomeronasal (Vmn1r: 50, 103, 210, 211; Vmn2r: 3, 23, 99) receptors and RIKEN cDNA 5430402E10, also known as odorant-binding protein. (4) Conclusions: Finasteride treatment of male adult rats may cause changes in the testicular transcriptome of their male offspring, leading to a defective function of spermatozoa in response to odorant-like signals, which are recently more and more often noticed as significant players in male fertility.
... Finasteride 1 mg selectively inhibits type II 5α-reductase that converts testosterone into more androgenic DHT. Although Finasteride is regarded as the first line treatment for male androgenic alopecia, patients tend to reach a plateau after several years' treatment [24]. The trend in hair lotion development is to focus on criteria suggested by the clinical practice guidelines for AGA. ...
Article
Full-text available
Background: The efficacy of Finasteride 1mg, the first-line treatment for male Androgenetic Alopecia (AGA), tends to reach a plateau after several years’ treatment. Up to date, effective and safe options are limited because current modalities managing AGA have so far not taken into account the two key issues particularly relevant to excessive hair loss: the early onset of catagen (due to premature hair follicular cell apoptosis) and the frequently observed sustained micro-inflammation in the scalp. Objective: We investigated the potential synergic effect of combining the oral finasteride 1mg, acting on conversion of testosterone to 5α-dihydrotestosterone, with CG210, a novel topical anti-hair loss product, acting on premature apoptosis and micro-inflammation in the scalp. Methods: We designed a 12-month, randomized, double-blind, placebo-controlled trial using CG210 in twenty AGA volunteers already using Finasteride 1mg for at least three years. Hair diameters were assessed and compared for hair pattern improvement. Results: The increase of hair diameter in the “Finasteride 1 mg + topical CG210” group was 37.7% more than that in “Finasteride 1 mg + topical placebo” group (p=0.002). No side effect was observed. Conclusion: In addition to 5α-reductase inhibitors, our study puts forward the approach to simultaneously address both premature cell apoptosis in the hair follicles and micro-inflammation in the scalp. The results suggest an efficient mode in the management of AGA with improved efficacy over the currently referenced modality. Furthermore, the studied topical CG210 may represent a new option for alopecia subjects, including those under finasteride 1mg, to improve their hair pattern.
... Although treatment with oral finasteride offers temporary relief for hair loss in treating male AGA, the long-term use of finasteride, usually taking several months to a year or more, seems to be challenging for most patients due to its potential side effects. Hair regrowth can be lost again within 12 months after discontinued treatment [4]. Topical minoxidil has also been approved by the Food and Drug Administration (FDA) for the treatment of AGA, although the molecular mechanism(s) involved in the hair growth-promoting effect of minoxidil is still not fully understood [5]. ...
Article
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Introduction: Although it has been reported that the anti-diabetic drug metformin has multiple extra-hypoglycemic activities, such as anti-oxidation, anti-aging and even anti-tumor, topical metformin also can induce hair regeneration, but the precise mechanism involved in that process is still unclear. Objectives: To assess the effect of metformin on hair growth in a mouse hair follicle reconstitution model generated by in vitro self-assembled three-dimensional aggregates of epidermal and dermal cells (3D aggregates). Methods: Epidermal cells and dermal cells were isolated and cultured from the mouse skin of fifty C57BL/6 mouse pups (1-day-old). For tracing the distribution of dermal cells during the self-assembly process of 3D aggregates, the dermal cells were labeled with Vybrant Dil cell-labelling solution and mixed with epidermal cells at 1:1 ratio. Formed 3D aggregates were treated with 10 mM metformin and then were grafted into recipient BALB/c nude mice. The biomarkers (HGF, CD133, ALP, β-catenin and SOX2) associated with the hair-inductive activity of dermal cells were detected in the grafted skin tissues and in cultured 3D aggregates treated with metformin using immunofluorescent staining, quantitative real-time RT-PCR (qRT-PCR), and western blotting. Furthermore, the expression levels of CD133 were also examined in dermal cells with different passage numbers using qRT-PCR and western blotting. Results: Metformin directly stimulates the activity of alkaline phosphatase (ALP) of cultured 3D aggregates, upregulates both the protein and mRNA expression levels of molecular markers (HGF, CD133, ALP, β-catenin and SOX2) and improves the survival rate of reconstituted hair follicles. Moreover, we also found that metformin increases the expression of CD133 in dermal cells thus maintaining their trichogenic capacity that would normally be lost by serial subculture. Conclusions: These results suggest that metformin can promote hair follicle regeneration in vitro through up-regulation of the hair inductive capability of dermal cells, warranting further evaluation in the clinical treatment of male or female pattern hair loss.
... 48 A well-known large Japanese study of over 3000 males with AGA demonstrated that 11.1% of subjects exhibited significant hair regrowth with finasteride use, 36.5% exhibited moderate growth, and 39.5% had only a slight increase in hair growth over a period of 3 years. 49 ...
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Background Androgenetic alopecia (AGA) is the most common form of hair loss consisting of a characteristic receding frontal hairline in men and diffuse hair thinning in women, with frontal hairline retention, and can impact an individual's quality of life. The condition is primarily mediated by 5-alpha-reductase and dihydrotestosterone (DHT) which causes hair follicles to undergo miniaturization and shortening of successive anagen cycles. Although a variety of medical, surgical, light-based and nutraceutical treatment options are available to slow or reverse the progression of AGA, it can be challenging to select appropriate therapies for this chronic condition. Aims To highlight treatment options for androgenetic alopecia taking into consideration the efficacy, side effect profiles, practicality of treatment (compliance), and costs to help clinicians offer ethically appropriate treatment regimens to their patients. Materials and Methods A literature search was conducted using electronic databases (Medline, PubMed, Embase, CINAHL, EBSCO) and textbooks, in addition to the authors' and other practitioners' clinical experiences in treating androgenetic alopecia, and the findings are presented here. Results Although topical minoxidil, oral finasteride, and low-level light therapy are the only FDA-approved therapies to treat AGA, they are just a fraction of the treatment options available, including other oral and topical modalities, hormonal therapies, nutraceuticals, PRP and exosome treatments, and hair transplantation. Discussion Androgenetic alopecia therapy remains challenging as treatment selection involves ethical, evidence-based decision-making and consideration of each individual patient's needs, compliance, budget, extent of hair loss, and aesthetic goals, independent of potential financial benefits to the practitioners.
... Notably, combination therapy has been proposed to achieve the best efficacy expediently. However, oral medication requires long-term use and exhibit certain associated side effects, topical medication has limited and inaccurate efficacy, and invasive treatment carries surgical risks [19][20][21]. And hair loss is associated with considerable psychological and emotional distress and decreased quality of life. ...
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Background: Androgenetic alopecia (AGA) represents the most frequent clinical complaint encountered by dermatologists and is characterized by a progressive miniaturization of the hair follicle. However, the efficacy and safety of current medical treatment remain limited, and more personalized therapeutic approaches for AGA are needed. Therefore, the present study is aimed at investigating the efficacy and safety of botulinum toxin type A (BTA) in patients with AGA. Methods: 63 patients with AGA meeting the inclusion criteria were included in this study and treated with BTA injection or BTA injection combined with oral finasteride (FNS). In the scalp, 30 sites were injected with 100 U of BTA in each site and patients received BTA after every 3 months for a total of 4 times. Hair counts, head photographs, evaluation scores, and self-assessment were assessed in patients with AGA. Results: Hair counts in both groups at all time points were significantly higher as compared with those before treatment. After 4 times of treatment, hair counts in the BTA+FNS group were higher than those in the BTA group. Hair growth and density were significantly augmented, and the area of hair loss was attenuated after each treatment as revealed by head photographs. The effective rates of BTA and BTA+FNS groups were 73.3% and 84.8%, respectively, following 4 times treatment. Conclusion: BTA is a safe and effective therapeutic strategy for the treatment of AGA without adverse effects, and BTA combined with FNS exhibited a superior therapeutic effect than BTA alone.
... It is all around acknowledged that dihydrotestosterone (DHT) is answerable for androgenetic alopecia in people. DHT prompts scaling down of hair follicles by a few components including quickening the mitotic pace of the lattice, shortening of hair cycle, expanding telogen shedding, just as expanding the span of the slack stage or catagen [12]. ...
... In our experience, sexual side effects, such as decreased libido and erectile dysfunction, as well as testicular tenderness and (rarely) gynecomastia have been reversible upon cessation of oral finasteride treatment, and without any sequelae. This is consistent with the respective data on safety and efficacy of 1 mg oral finasteride in the so far largest study of 3,117 Japanese men treated for AGA published in 2012 [7]. ...
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Objective: To investigate the relationships between pharmacologically induced deprivation of dihydrotestosterone, sexual arousal, libido and hand preference, by comparing the self-reported sexual response prior to and during reception of the anti-androgen finasteride in men undergoing treatment for male pattern baldness. Patients and method: In total, 33 sexually healthy Romanian men participated in this study. Patients prospectively provided information regarding their sexual functioning (over 4 weeks), as measured by the International Index of Erectile Function (IIEF) prior to and after commencing treatment with 1 mg finasteride for male pattern baldness. Results: Overall IIEF scores as well as the erectile function, orgasmic function, sexual desire and overall satisfaction subscales showed group, treatment and group by treatment effects. The intercourse satisfaction subscale showed group and group by treatment effects. On most subscales, right-handed men showed no effect or lower sexual function whereas left-handed men reported no effect or improved sexual function, primarily. Conclusions: These results suggest that the sexual effects of dihydrotestosterone deprivation may depend on handedness--a proxy variable that may represent cognitive style--which lends further support to the idea of two distinct neuroendocrine psychosexual axes. They further suggest that detection of such sexual effects may be enhanced by using research methodologies and communication strategies that increase patients' sensitization to such effects.
Article
Two meta-analyses conclude that finasteride treatment of androgenic alopecia (AGA) is safe but do not assess quality of safety reporting. To assess safety reporting for clinical trial reports of finasteride for AGA. MEDLINE, ClinicalTrials.gov, and a clinical data repository for an academic medical center. Published clinical trial reports for finasteride treatment of AGA. For each trial, we assessed quality of adverse event reporting, extracted the number and type of adverse events in treatment and placebo groups, and assessed duration of safety evaluation and adequacy of blinding. Two observers independently extracted the data; differences were resolved by consensus. We assessed generalizability in a large cohort of men prescribed finasteride, 1.25 mg/d or less, by assessing for eligibility in the finasteride-AGA pivotal trials. Quality was assessed as adequate, partially adequate, inadequate, or no events reported. We used funnel plots of the hazard ratio to assess bias. Of 34 clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events. Funnel plots were asymmetric with a bias toward lower odds ratio for sexual adverse effects, suggesting systematic underdetection. No reports assessed adequacy of blinding, 18 (53%) disclosed conflicts of interest, and 19 (56%) received funding from the manufacturer. Duration of drug safety evaluation was 1 year or less for 26 of 34 trials (76%). Of 5704 men in the clinical data repository who were treated for AGA with finasteride, 1.25 mg/d or less, for AGA, only 31% met inclusion criteria for the pivotal trials referenced in the manufacturer's full prescribing information and 33% took finasteride for more than 1 year. Available toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of AGA, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for AGA. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of AGA.
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Background Androgenetic alopecia (AGA), or pattern hair loss, is a common disorder in both Asian men and women. There are several guidelines for the treatment of AGA which are suitable for Caucasian patients; however, each of these has some limitations. Furthermore, in comparison with Caucasian patients, Asian patients with AGA have different types of hair loss and family histories which may alter the treatment response. There is currently no published AGA guideline for Asian patients. Objectives The Asian Consensus Committee for Androgenetic Alopecia aimed to develop an algorithmic guideline, based on the basic and specific (BASP) classification, for the treatment of AGA especially in Asian patients. Methods The committee collaborated extensively on reviewing available literature on AGA treatment in order to formulate an algorithmic guideline on AGA management. Results Previously published guidelines based on pre-existing classifications of AGA cannot easily classify the patterns of AGA that are more frequently seen in Asians. The BASP classification not only facilitates the development of a unified and simplified algorithm, but also overcomes the disadvantages of previously reported classification systems. Conclusions The proposed treatment guideline for AGA based on the BASP classification may be useful for dermatologists in their approach to treating Asian patients with AGA in clinical practice. Ideally, clinicians should try to utilize this guideline consistently in their practice to monitor treatment response with the goal of enhancing successful outcomes. This will help boost patients' confidence and self-esteem, thus improving patients’ compliance with the prescribed treatments.
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Dihydrotestosterone is the main androgen causative of androgenetic alopecia, a psychologically and physically harmful condition warranting medical treatment. We sought to compare the efficacy and safety of dutasteride (type 1 and 2 5-alpha reductase inhibitor) with finasteride (type 2 5-alpha reductase inhibitor) and placebo in men with androgenetic alopecia. Men aged 20 to 50 years with androgenetic alopecia were randomized to receive dutasteride (0.02, 0.1, or 0.5 mg/d), finasteride (1 mg/d), or placebo for 24 weeks. The primary end point was hair count (2.54-cm diameter) at week 24. Other assessments included hair count (1.13-cm diameter) and width, photographic assessments (investigators and panel), change in stage, and health outcomes. In total, 917 men were randomized. Hair count and width increased dose dependently with dutasteride. Dutasteride 0.5 mg significantly increased hair count and width in a 2.54-cm diameter and improved hair growth (frontal view; panel photographic assessment) at week 24 compared with finasteride (P = .003, P = .004, and P = .002, respectively) and placebo (all P < .001). The number and severity of adverse events were similar among treatment groups. The study was limited to 24 weeks. Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated.
Article
Objective: To evaluate the efficacy and safety of finasteride 1 mg/d on male androgenetic alopecia (AGA) patients in Hangzhou Region. Methods: Clinical data and photographs of male AGA treated with finasteride 1 mg/day were collected from January 2010 to December 2011 at our clinic. The efficacy was evaluated by patients' self-assessments and doctors' photographic assessments with the standardized 7-point rating scale. The relationship between clinical efficacy and clinic characteristics was also analyzed. Results: The total effective rate was 75% in male AGA treated with finasteride 1 mg/day. The rates of slight, moderate, and significant improvement were 38.04%, 23.37% and 13.59%, respectively. The response rates were associated with involved sites, disease severity and duration of treatment, and were independent of age and course. Mild adverse reactions occurred in 4 cases. Conclusion: Oral finasteride 1 mg/d is effective for male AGA without considerable side effects.
Article
Ethnopharmacological relevance alopecia is a hair disorder that can add a significant medical and psychological burden to patients. Currently, the FDA-approved drugs for the treatment of androgenetic alopecia (AGA) are minoxidil and finasteride and immunosuppressives are therapeutic options for alopecia areata (AA), but the objective adverse effects and high cost of these treatments reduce patient compliance and thus the effectiveness of the drugs. Traditional Chinese medicine (TCM) has good efficacy, a high safety profile and low treatment costs, but its mechanism of action is still not fully understood. The use of signaling pathways to modulate hair loss is a major direction in the study of the pathogenesis and pharmacology of alopecia. Aim of the study This review aims to collect the results of experimental studies related to alopecia, to screen previously documented combinations of herbs claimed to be effective based on the herbs and their constituent compounds used in the identified studies, and to uncover other useful information that we hope will better guide the clinical application and scientific research of drug combinations or individual herbs for the treatment of alopecia. Materials and methods We have reviewed experimental studies to determine the methods used and the mechanisms of action of the herbs and constituent compounds. The following keywords were searched in databases, including PubMed, EMBASE, CNKI and CSTJ.” Medicinal plants” “Chinese herbal medicine”, “hair loss”, " alopecia”, “androgenetic alopecia” and " alopecia areata ". We also collected combinations of drugs from books approved by various schools for screening. Results Using known combinations of compounds within herbal medicine to match the documented combinations, 34 topical combinations and 74 oral combinations were identified, and among the 108 herbal combinations screened Angelica, Rehmannia glutinosaLigusticum chuanxiong hort, Radix Rehmanniae, etc. The number of occurrences was very high, and the association with vascular drugs was also found to be very close. Conclusions This review further elucidates the therapeutic mechanisms of the compounds within the herbal components associated with alopecia and screens for other combinations that may be dominated by this component for the treatment of alopecia, uncovering compounds from other drugs that may be key factors in the treatment of alopecia. This improvement will provide a better quality of evidence for the effectiveness of herbs and compounds used to treat alopecia.
Chapter
Few dermatologic problems carry as much emotional overtones as the complaint of hair loss. Adding to some patient’s worry may be prior frustrating experiences with physicians, who tend to trivialize complaints of hair loss or dismiss them completely. This attitude on the part of physicians is related either to lack of comprehension of the impact of hair loss on quality of life or to lack of confidence in the treatment of alopecia. Treatment options are available, though limited, both in terms of indications and of efficacy. Success depends not only on comprehension of the underlying pathology but also on unpatronizing sympathy from the part of the physician.
Chapter
A side effect is an effect that is secondary to the one intended. The term is primarily used to describe unwanted or adverse effects. In the broader sense, the term can also apply to unintended, but beneficial effects from the use of the drug. An example is the hair growth-promoting effect of minoxidil that was originally a drug intended to lower the blood pressure but proved to be a powerful trichotrophic agent.
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The post-Finasteride syndrome (PFS) has been claimed to occur in men who have taken oral finasteride to treat hair loss or benign prostatic hyperplasia. While the incidence of persistent sexual, mental, and physical side effects despite quitting finasteride is unknown, and the condition is not recognized by the scientific community, individuals who suffer from PFS do present with very distinctive and homogenous symptoms. The concept has emerged from reports of nondermatologists, neuroendocrinological research, case reports, and uncontrolled studies. These have been scrutinized by hair experts who found that persistent sexual side effects were only documented in low-quality studies with a strong bias selection and a significant nocebo effect. Others totally dispute the credibility of the PFS. In any case, the PFS is a problem that has to be dealt with. Low-quality studies neither confirm nor refute the condition as a valid nosologic entity. Therefore, it is as inappropriate to dismiss the condition, as it would be to demonize finasteride for the treatment of male pattern hair loss. Whether the PFS represents a nocebo reaction or a real drug adverse event is irrelevant, while the best way to alleviate the emotional distress related to hair loss is to effectively treat the condition causing the problem. It is not sufficient to only discuss the plausibility of the PFS. There is a need for practical recommendations to include such important issues as patient selection and risk assessment, appropriate patient information, how to react in case of drug-related adverse events, issues of fertility and malignancy, management of the PFS, and alternatives, specifically the use of topical finasteride. It is the aim of this commentary to provide the respective information. © 2019 International Journal of Trichology | Published by Wolters Kluwer - Medknow.
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Background and Objectives: The most common type of hair loss is androgenetic alopecia. Mesotherapy is considered a controversial treatment for this condition. The aim of this study was to examine the safety and efficacy of mesotherapy in the treatment of androgenetic alopecia. Methods: A systematic review was conducted to identify and evaluate relevant studies on mesotherapy for the treatment of androgenetic alopecia. The Cochrane Library, PubMed, Embase, Scopus, and Web of Science were searched until November 2017. The grey literature and references of key studies were also scanned for additional citations. In addition, quality assessment of studies was conducted using the Jadad scale. Results: Five studies including 344 patients were considered eligible for the review. Of five studies included in this review, three were randomized controlled trials (RCTs) and two were non-RCTs. In previous studies, mesotherapy was performed using dutasteride, minoxidil, and finasteride. As the analysis revealed, quality of retrieved studies was poor. The results showed that mesotherapy leads to the improvement of efficacy outcomes. However, in one study, mesotherapy was not shown to be effective regarding some outcomes. No significant adverse effects were reported for mesotherapy. Conclusions: Although the findings of previous studies suggest that mesotherapy is a safe and effective treatment for androgenetic alopecia, further research is needed to confirm this finding.
Article
Androgenic alopecia (AGA) is an aesthetic condition with varying psycho-social implications, easily accepted by some patients and tolerated only with difficulty by others. Modern therapeutic options such as 5α-reductase inhibitors have significant outcomes, but also exert significant side effects in a subset of patients. The literature describes three distinct situations regarding finasteride administration, a compound largely used for AGA. Some studies show finasteride to be very safe with minimal or no side effects. Other studies take a more cautious approach, recognizing such side effects but, at the same time, considering the putative relationship between finasteride and adverse effects to be disputable, given that placebo administration in AGA is associated with relatively similar or even more severe side effects. Finally, some authors/studies are concerned that, when compared to placebo, finasteride administration may result in side effects with greater frequency and severity, and sometimes that persist even after treatment cessation in the form of post-finasteride syndrome. Several factors presented in this paper appear to explain finasteride inconsistency regarding its therapeutic and side effects. Such factors should be further investigated and used to categorize subjects into distinct subgroups, either predisposed to adverse reactions or more tolerant to the finasteride administration.
Article
Post-finasteride syndrome (PFS) has been claimed to occur in men who have taken oral finasteride to treat either hair loss or benign prostatic hyperplasia, independent of age, dosage, or indication. By definition, the condition is characterized by sexual dysfunction, somatic symptoms, and psychological disorders that persist after cessation of finasteride treatment. As yet, the condition is not recognized by the medical community, although individuals who suffer from PFS present with relatively homogenous symptoms. The concept of PFS has emerged from reports of non-dermatologists, neuroendocrinological research and reflections, and uncontrolled studies of low quality and with a strong bias selection, while a significant nocebo effect among patients informed about possible side effects of finasteride is recognized. There are no predictive factors for the risk of development of PFS. Nevertheless, it has been suggested that a patient history of preexisting mental health disorder, particularly depression, may put patients at an increased risk. We report the first case of PFS in a long-standing (over 20 years) dermatotrichological practice with frequent finasteride prescription observed in a 25-year-old male following dutasteride treatment for male androgenetic alopecia. There was circumstantial evidence that PFS may represent a delusional disorder of the somatic type, possibly on a background of a histrionic personality disorder, which would explain the refractoriness of the condition and a high degree of suggestibility.
Article
Post-finasteride syndrome (PFS) is a constellation of serious adverse side effects manifested in clinical symptoms that develop and persist in patients during and/or after discontinuing finasteride treatment in men with pattern hair loss (androgenetic alopecia) or benign prostatic hyperplasia. These serious adverse side effects include persistent or irreversible sexual, neurological, physical and mental side effects. To date, there are no evidence-based effective treatments for PFS. Although increasing number of men report persistent side effects, the medical community has yet to recognize this syndrome nor are there any specific measures to address this serious and debilitating symptoms. Here we evaluate the scientific and clinical evidence in the contemporary medical literature to address the very fundamental question: Is PFS a real clinical condition caused by finasteride use or are the reported symptoms only incidentally associated with but not caused by finasteride use? One key indisputable clinical evidence noted in all reported studies with finasteride and dutasteride was that use of these drugs is associated with development of sexual dysfunction, which may persist in a subset of men, irrespective of age, drug dose or duration of study. Also, increased depression, anxiety and suicidal ideation in a subset of men treated with these drugs were commonly reported in a number of studies. It is important to note that many clinical studies suffer from incomplete or inadequate assessment of adverse events and often limited or inaccurate data reporting regarding harm. Based on the existing body of evidence in the contemporary clinical literature, the author believes that finasteride and dutasteride induce a constellation of persistent sexual, neurological and physical adverse side effects, in a subset of men. These constellations of symptoms constitute the basis for PFS in individuals predisposed to epigenetic susceptibility. Indeed, delineating the pathophysiological mechanisms underlying PFS will be of paramount importance to the understanding of this syndrome and to development of potential novel therapeutic modalities.
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Zusammenfassung Ein Patient wurde im Jahre 2013 mit Propecia 1 mg aufgrund einer androgenetischen Alopezie behandelt. Es traten bei ihm eine sexuelle Dysfunktion mit Erektionsschwäche und vermindertem sexuellen Verlangen auf, die auch nach Abbrechen der Therapie anhielt. Daraufhin machte der Patient gegenüber dem Facharzt einen Behandlungsfehler geltend aufgrund mangelhafter Aufklärung mit der Konsequenz einer fehlerhaften Behandlung. Der urologische Fachgutachter bejahte den Behandlungsfehler. Er war der Meinung, dass, auch wenn nur Einzelfälle mit geringer wissenschaftlicher Basis über das Post-Finasterid-Syndrom bekannt wären, der Facharzt über diese schwerwiegende Nebenwirkung den Patienten hätte aufklären müssen, dies insbesondere bei einer rein kosmetischen Indikation männlicher Glatzenbildung. Der dermatologische Gutachter schloss sich nicht dieser Meinung an. Im Verordnungsjahr 2013 existierten lediglich 2 Publikationen über Einzelfälle des Post-Finasterid-Syndroms. Diese Publikationen in peripheren Zeitschriften fanden noch kein allgemeines wissenschaftliches Echo und führten auch nicht zur Änderung der Fachinformation. Erst im Verlauf der Folgejahre wurde in der Postmarketing-Phase das Syndrom öfters beschrieben und fand auch Eingang in die Fachinformation. Da für die Beurteilung das im Jahre der Verordnung geltende wissenschaftliche Wissen entscheidend ist, kann dem Facharzt kein Behandlungsfehler vorgeworfen werden.
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If during development anything goes wrong at the time of development be it in fusion, or mullerian ducts getting resorbed as well as urogenital sinus might end up in a variety of congenital malformations although similar, those of the body of the uterus, cervix, vagina as well as fallopian tubes. Although a variety of classifications as well as definitions have been developed no uniformity exists in globally assessing and evaluating usefulness of surgical procedures for mullerian anomalies, of these the most important one is septate uterus that has undergone varied classifications right from American Fertility Society (ASE) to European Society of Human Reproduction and Embryology (ESHRE)/ European Society of Gynecological Endoscopy (ESGE) and American Society of Reproductive Medicine (ASRM) classifications. Lot of discrepancy exists in the ESHRE/ESGE and ASRM classifications thus need for a modified ASRM classification is urgently needed to bring in uniformity regarding management and evaluate criteria as well as results of surgery uniformly as per Ludwin A the group having done maximum work on the subject. Further details of complicated malformations like Robert’s uterus, blind hemivagina, cervical atresia has been discussed in detail.
Article
Background: Androgenetic alopecia (AGA) is the most frequent form of alopecia. Telogen effluvium (TE) is a common form of diffuse hair loss mainly observed in women. The aim of our study was to evaluate the efficacy of a topical trichological treatment containing a new combination of molecules for the treatment of AGA and TE. Methods: In-vitro tests were performed analyzing different combinations and concentrations of arginine, zinc and a third enzymatically neutral substance called AA on human follicles dermal papillae cells. These tests evaluated the capability of inhibiting the 5α-reductase (5-AR) enzyme and the 5-AR gene expression. We also performed an in-vivo study. Forty individuals affected by AGA and TE were divided into two groups. One group was administered a combination of zinc and arginine (lotion A), whilst the other placebo (lotion B). Therapy duration was 23 consecutive weeks. Follow-up examinations and pull tests occurred at baseline, after 6 weeks and at the end of the therapy. On 20 randomly selected patients we also performed noninvasive phototrichograms. Results: In-vitro tests showed that the combination had a strong statistically significant inhibitory activity on 5-AR of dermal papillae cells. Number of hairs removed by pull-test significantly decreased at T0, T1 and T2 in patient treated with lotion A. We also observed an increase in the percentage of anagen hair and a decrease in telogen hairs. Concerning phototrichograms, all objective parameters evaluated showed better results in the lotion A group when compared with the placebo group. Conclusions: Based on our results, the combination of arginine and zinc tested in our study could represent a good therapeutic option for the treatment of AGA and TE and it might represent a valid alternative to finasteride.
Article
Abstract Finasteride is a 5 alpha reductase inhibitor(5-α RI) that has been used for the treatment of benign prostatic hyperplasia (BPH) as well as androgenic alopecia for relatively young men for long. That a group of side effects not only develop following its use but persist following cessation of the drug with the syndrome coined as ‘’Post Finasteride Syndrome ‘’(PFS) has been realized for long. What is the reason that we as physicians refuse to appreciate this despite serious adverse effects like persistent sexual dysfunctions, suicidal ideation, and other metabolic effects like risk of developing type 2 diabetes mellitus (DM), lacrimal dysfunction, renal abnormalities we refuse to appreciate these drug induced syndrome. Infact when rimonabant (a CB1 receptor agonist)was being studied as an antiobesity syndrome and was shown to cause suicidal ideation immediately it was with drawn from trials. What pushes us not to use the same criteria for these 5-α RI including Finasteride and dutasteride knowing that how important they are in human physiology and how severe harm we might cause to then poor unknowing man who is not even told that he might develop erectile dysfunction, loss of pleasure in life a prize he has to pay to get his hair back. This comprehensive review has been done with an effort for our medical community who took hippocratic oath to serve the humanity why they cannot get up and protest against the side effects that in a subgroup of men might get irreversible side effects rather than label the poor men as psychotic or delusional. These symptoms have been emphasized by Traish along with other groups as men who have epigenetic susceptibility. Time has come that not only we start actually looking deep down into the pathophysiology and get an insight into this mysterious, elusive diagnosis that refuses to get accepted despite a lot of body of evidence.Hopefully a change in the attitude of our community will come. Keywords: 5-α RI; ‘’Post Finasteride Syndrome ‘’(PFS); persistent sexual dysfunctions; suicidal ideation; BPH; metabolic dysfunctions
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This article introduces the reader to the key components of hair transplantation, including evaluating the surgical patient, deciding whether to perform follicular unit transplantation (FUT) or follicular unit extraction (FUE), understanding the key components of these procedures, and establishing practical preoperative and postoperative protocols.
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Background and objectives: Finasteride 1 mg/day is indicated for androgen-dependent conditions such as male androgenetic alopecia (AGA). Methods: The literature is comprehensively summarized on the pharmacodynamics, pharmacokinetics, mechanism of action, and metabolism of finasteride. Pairwise and network meta-analyses were performed to assess the efficacy of finasteride reported in clinical trials. The adverse events profile is described along with the post-marketing reports. Results and conclusion: Finasteride 1 mg/day significantly increased total hair count compared to placebo after 24 weeks (mean difference =12.4 hairs/cm2, p < 0.05), and 48 weeks (mean difference =16.4 hairs/cm2, p < 0.05). The efficacy of the two doses of finasteride (5 mg/day and 1 mg/day) and topical finasteride (1% solution) were not significantly different. The most commonly reported sexual events include erectile dysfunction and decreased libido. Increasing patient complaints and analysis of the FAERS database led to the inclusion of depression in the FDA label in 2011, as men were found to be at a risk of suicide due to the persistent sexual side effects, commonly termed as post-finasteride syndrome. Finasteride is shown to be reasonably tolerated in both men and women; however, patients need to be educated about the possible short- and long-term side-effects.
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Organ replacement regenerative therapy is purported to enable the replacement of organs damaged by disease, injury or aging in the foreseeable future. Here we demonstrate fully functional hair organ regeneration via the intracutaneous transplantation of a bioengineered pelage and vibrissa follicle germ. The pelage and vibrissae are reconstituted with embryonic skin-derived cells and adult vibrissa stem cell region-derived cells, respectively. The bioengineered hair follicle develops the correct structures and forms proper connections with surrounding host tissues such as the epidermis, arrector pili muscle and nerve fibres. The bioengineered follicles also show restored hair cycles and piloerection through the rearrangement of follicular stem cells and their niches. This study thus reveals the potential applications of adult tissue-derived follicular stem cells as a bioengineered organ replacement therapy.
Article
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Background and aim: Androgenetic alopecia (AGA) is undoubtedly the most common form of hair loss in males. It is a condition which may cause cosmetic and psychosocial problems in androgen-dependent cases. In this open, randomized and comparative study we evaluated the efficacy of oral finasteride and 5% topical minoxidil treatment for 12 months in 65 male patients with mild to severe AGA. Methods: We randomly assigned 40 (61.53%) patients to receive 1 mg/day oral finasteride for 12 months, and 25 (38.47%) patients applied 5% topical minoxidil solution twice daily for 12 months. Results: There were no significant differences between the 2 groups considering age, age of onset of hair loss, family history and type of hair loss (p > 0.05). In the clinical evaluation at the endpoint of treatment, the clinical cure rates (i.e. increased intensity of hair) were 80% (32/40) for the oral finasteride group and 52% (13/25) for the 5% topical minoxidil group. Encountered side effects were all mild, and there was no need to stop the treatment. In the group given oral finasteride, side effects were noted in 7 patients: 6 patients suffered from loss of libido, and 1 patient had an increase in other body hairs; irritation of the scalp was seen in 1 patient in the group administered 5% minoxidil. These adverse events disappeared as soon as the treatment was stopped. The laboratory data on both drug groups did not show any statistically or clinically significant intragroup changes from baseline values to the endpoint (p > 0.05), except the level of serum total testosterone which was increased, and free testosterone and serum prostate-specific antigen in the finasteride group which were statistically decreased from baseline values to the endpoint (p < 0.05). Conclusion: In this comparative study of systemic finasteride and topical minoxidil, it was concluded that both drugs were effective and safe in the treatment of mild to severe AGA, although oral finasteride treatment was more effective (p < 0.05). Adverse events were not considered important either, and these side effects disappeared as soon as the treatment was stopped.
Article
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Finasteride is a type 2 5 alpha-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss (androgenetic alopecia). The objective of this study was to identify the optimal dosage of finasteride and to evaluate its efficacy and safety in the treatment of Japanese men with male pattern hair loss. In this double- blind randomized study, 414 Japanese men with male pattern hair loss received finasteride 1 mg (n = 139), finasteride 0.2 mg (n = 137), or placebo (n = 38) once daily for 48 weeks. Efficacy was evaluated by global photographic assessment, patient self-assessment, and investigator assessment. All efficacy endpoints showed significant improvement with finasteride therapy by 12 weeks (p < 0.05 versus placebo). At 48 weeks, 58%, 54%, and 6% of men in the finasteride 1 mg, finasteride 0.2 mg, and placebo groups, respectively, had improved based on assessments of global photographs. All efficacy endpoints were numerically superior for the 1 mg dose over the 0.2 mg dose at 48 weeks. Finasteride treatment was generally well tolerated. Finasteride 1 mg\day slows hair loss and improves hair growth in Japanese men with male pattern hair loss.
Chapter
Hamilton (1951), in a frontier work, extensively studied the developing patterns of scalp hair in men and women from the prenatal period through the tenth decade. He divided the balding patterns into eight types with three sub-divisions, then compared the incidence of baldness between Caucasian and Chinese.
Article
Background. Finasteride 1 mg (Propecia®) is indicated for the treatment of men with androgenetic alopecia (male pattern hair loss, MPHL). However, the long-term (> 2 years) efficacy and safety of finasteride in this population has not been previously reported. Objectives. To assess the efficacy and safety of finasteride in men with MPHL compared to treatment with placebo over five years. Methods. In two 1-year, Phase III trials, 1,553 men with MPHL were randomized to receive finasteride 1 mg/day or placebo, and 1,215 men continued in up to four 1-year, placebo-controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with finasteride led to durable improvements in scalp hair over five years (p ≤ 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. Finasteride was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL, long-term treatment with finasteride 1 mg/day over five years was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment.
Article
Background: Androgenetic alopecia (male pattern hair loss) is caused by androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone (DHT) implicated as a contributing cause. Finasteride, an inhibitor of type II 5α-reductase, decreases serum and scalp DHT by inhibiting conversion of testosterone to DHT. Objective: Our purpose was to determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss. Methods: In two 1-year trials, 1553 men (18 to 41 years of age) with male pattern hair loss received oral finasteride 1 mg/d or placebo, and 1215 men continued in blinded extension studies for a second year. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, and review of photographs by an expert panel. Results: Finasteride treatment improved scalp hair by all evaluation techniques at 1 and 2 years (P < .001 vs placebo, all comparisons). Clinically significant increases in hair count (baseline = 876 hairs), measured in a 1-inch diameter circular area (5.1 cm2 ) of balding vertex scalp, were observed with finasteride treatment (107 and 138 hairs vs placebo at 1 and 2 years, respectively; P < .001). Treatment with placebo resulted in progressive hair loss. Patients’ self-assessment demonstrated that finasteride treatment slowed hair loss, increased hair growth, and improved appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Adverse effects were minimal. Conclusion: In men with male pattern hair loss, finasteride 1 mg/d slowed the progression of hair loss and increased hair growth in clinical trials over 2 years. (J Am Acad Dermatol 1998;39:578-89.)
Article
The need for a widely accepted, accurate, and reproducible standard of classification for male pattern baldness has increased with the advent and increasing popularity of hair transplant surgery. This report establishes such a classification, and reports its use in determining the incidence of male pattern baldness at various ages in 1,000 white adult male subjects. The action of testosterone as an incitant in male pattern baldness is well known, but this study points out the continued effect of time, even in later years. Since most hair transplant surgery is peformed on subjects with male pattern baldness, and because the success of hair transplant surgery is largely dependent on proper patient selection, a complete understanding of male pattern baldness is essential for consistently good results with hair transplantation.
Article
Androgenetic alopecia (male pattern hair loss) is caused by androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone (DHT) implicated as a contributing cause. Finasteride, an inhibitor of type II 5alpha-reductase, decreases serum and scalp DHT by inhibiting conversion of testosterone to DHT. Our purpose was to determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss. In two 1-year trials, 1553 men (18 to 41 years of age) with male pattern hair loss received oral finasteride 1 mg/d or placebo, and 1215 men continued in blinded extension studies for a second year. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, and review of photographs by an expert panel. Finasteride treatment improved scalp hair by all evaluation techniques at 1 and 2 years (P < .001 vs placebo, all comparisons). Clinically significant increases in hair count (baseline = 876 hairs), measured in a 1-inch diameter circular area (5.1 cm2) of balding vertex scalp, were observed with finasteride treatment (107 and 138 hairs vs placebo at 1 and 2 years, respectively; P < .001). Treatment with placebo resulted in progressive hair loss. Patients' self-assessment demonstrated that finasteride treatment slowed hair loss, increased hair growth, and improved appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Adverse effects were minimal. In men with male pattern hair loss, finasteride 1 mg/d slowed the progression of hair loss and increased hair growth in clinical trials over 2 years.
Article
A 24-month double-blind, randomized, placebo-controlled, parallel-group, multicenter study of 424 men was conducted to determine the efficacy and tolerability of finasteride 1 mg on hair growth/loss in men aged 41 to 60 years with mild-to-moderate, predominantly vertex male pattern hair loss. Efficacy was evaluated by review of global photographs of the vertex scalp taken at baseline and at Months 6, 12, 18, and 24 and by patient self-assessments and investigator clinical assessments of change from baseline in hair growth/loss collected at Months 6, 12, 18, and 24. Safety analyses included assessment of clinical and laboratory adverse experiences, including sexual adverse experiences. Analysis of global photographic assessment data showed significant improvement in hair growth for men in the finasteride group compared with those taking placebo beginning at Month 6 (p < 0.001) and maintained through Month 24 (p < 0.001). Results of the patient self-assessment and investigator assessments were consistent with those from the global photographic assessment. Finasteride 1 mg improved scalp hair growth in men aged 41 to 60 years with predominantly vertex male pattern hair loss compared with results seen with placebo. Improvement was evident by 6 months of treatment and continued through 24 months. Treatment with finasteride 1 mg was generally well tolerated.
Article
This study collected qualitative and quantitative data about the morphology, structure, geometry, water swelling, and mechanical properties of hair fibers from subjects of different ethnic origins. X-ray analysis, cross-sectional measurements, tensile testing, and water swelling were performed on samples of hair collected from Caucasian, Asian, and African subjects. No differences in the intimate structures of fibers were observed among these 3 types of hairs, whereas geometry, mechanical properties, and water swelling differed according to ethnic origin. In addition, the behavior of hair fiber under mechanical stress was visualized with environmental scanning electron microscopy.
Article
Pattern hair loss (PHL) can be classified into several patterns. Currently, the Hamilton-Norwood classification system for men and the Ludwig grade system for women are commonly used to describe patterns of hair loss. However, these pre-existing classifications have some limitations. To establish an acceptable, universal, and accurate standard of both male and female pattern hair loss and to report its use in determining the incidence of PHL. We developed a new classification system (BASP classification) and then applied this system to classify the types of PHL. The BASP classification was based on observed patterns of hair loss. The basic (BA) types represent the shape of the anterior hairline, and the specific types (SP) represent the density of hair on distinct areas (frontal and vertex). There are four basic types (L, M, C, and U) and two specific types (F and V). The final type is decided by the combination of the assigned basic and specific types. Between November 2004 and June 2005, 2213 Korean subjects, comprised of 1768 males and 445 females, were classified according to the BASP classification at 13 university dermatologic centers nationwide throughout South Korea, as a multicenter study of the Korean Hair Research Society. For both sexes, the majority of patients enrolled in the study were in the third and fourth decade of life (65.1% of males and 56.68% of females). In males, the older group as well as the younger group in the study were more likely to have little recession of the frontal hairline (classified as type M1 approximately 2) and diffuse thinning over the top of scalp (type F1 approximately 2). The women in the study developed typical female PHL. The subjects of our study were mostly outpatients and some inpatients who complained about hair loss, not the general population of Korea. The BASP classification is a new stepwise, systematic, and universal classification system for PHL, regardless of sex.
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Long term (3 years) efficacy and safety profiles of finasteride in Japanese men with AGA
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[Clinical efficacy of finasteride 1 mg among 708 patients with AGA (androgenetic alopecia)]
  • Sato
Guidelines for the management of androgenetic alopecia (2010) from Japanese dermatological association
  • Tuboi
[Long term (3 years) efficacy and safety profiles of finasteride in Japanese men with AGA (androgenetic alopecia)]
  • Kawashima
[Study on Japanese Hair]
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