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Background: Oral finasteride and topical minoxidil are the current standard of care for male androgenetic alopecia and a combination of the two treatments can be considered for greater efficacy. Clinical trials of topical finasteride have also yielded promising results, but routine care data are lacking. Aims: To examine patient‐reported outcomes of men with androgenetic alopecia who received topical finasteride admixed with minoxidil compared to the current standard of care (oral finasteride). Methods: Retrospective, cross‐sectional study with data from a German direct‐to‐consumer teledermatology platform between December 2021 and January 2023. Patient‐reported outcomes were collected through voluntary follow‐up questionnaires provided after 6 weeks on topical finasteride/minoxidil or oral finasteride treatment. Results: A total of 1545 patients who received topical finasteride/minoxidil treatment were included; 238 (15.4%) participated in the follow‐up questionnaire. At week six, 62.2% (148/238) reported positive changes in their hair appearance, and 44.1% (105/238) reported an improvement of self‐esteem. Treatment‐related adverse events were reported in 11.8% (28/238). Full treatment adherence was observed in 74.4% (177/238). Comparing the topical treatment group to those receiving oral finasteride, lower treatment adherence was reported, along with higher rates of local adverse events; no difference was found in the incidence of sexual adverse events. Conclusion: Based on patient‐reported outcomes, topical finasteride/minoxidil seems to be effective and well tolerated, but not superior to oral finasteride. Lower treatment adherence for topical usage must be considered when considering treatment options. Additional real‐world data are needed to further evaluate the efficacy and safety of topical finasteride/minoxidil. [ABSTRACT FROM AUTHOR]

Finasteride is commonly used for androgenetic alopecia (AGA) treatment. The aim of this study was to assess the therapeutic maintenance effect of a finasteride every other month (EOM) regimen and analyze clinical and laboratory differences in patients with AGA according to their treatment response. One hundred males with AGA who received finasteride 1 mg daily treatment for a year were enrolled in the study. At 1 year follow‐up, treatment responses of patients who completed the visit schedule were assessed using five scales. The patients were assigned to good or bad response groups according to their assessment. Further, they were randomly divided into two groups (daily vs. EOM) and treated with finasteride (1 mg) for 1 more year. At 2 years follow‐up, treatment efficacy was assessed. At 1‐year follow‐up, 36 patients completed the schedule, including eight and three patients in the good and bad response groups, respectively. At the 2‐year follow‐up, 23 patients completed the schedule, with nine in the daily group and 14 in the EOM group. Changes in global photographic assessment in the second year were 1.33 and 1.29 for the daily and EOM groups, respectively. The daily group showed an elevated hair density and lower concentration of dihydrotestosterone (DHT) and the DHT to testosterone ratio (DHT/T). However, the EOM group showed decreased hair density and elevated DHT and DHT/T. Following treatment response assessment after 1 year of treatment, the good response group showed early onset which was associated with maternal AGA. Analysis of serum androgen hormone magnitude of DHT reduction was much greater (54.4% vs. 44.4%). DHT/T was higher in the bad response group (1.98 vs. 2.33). We concluded that the finasteride EOM regimen showed similar maintenance effects to the daily regimen. [ABSTRACT FROM AUTHOR]

Men who report persistent sexual, neurological, and psychological side‐effects after discontinuing finasteride are said to have post‐finasteride syndrome. It is uncommon, but difficult for men suffering its effects. Although controversial, with no proven treatments, the syndrome should not be ignored. [ABSTRACT FROM AUTHOR]

Background: Frontal fibrosing alopecia (FFA) is a cicatricial alopecia with rapid epidemic growth. However, there is no agreement on the best therapeutic approach. Aims: To compare the therapeutic effects of finasteride as a first‐line systemic treatment of FFA versus hydroxychloroquine as a relatively safe and effective immunosuppressive drug. Methods: Thirty‐four female FFA patients were randomly assigned to receive either 400 mg/day of hydroxychloroquine or 2.5 mg/day of finasteride for 6 months. Topical treatments in both groups include pimecrolimus, mometasone, and minoxidil. Treatment efficacy was evaluated using the Frontal Fibrosing Alopecia Severity Score (FFASS), photography, and trichoscopy after 3 and 6 months. Results: Both the finasteride and hydroxychloroquine groups showed significant improvements in FFASS and trichoscopic scores (p < 0.01). However, there was no significant difference between the two groups during the study. Photographic assessment showed that more than 60% of patients in both groups had improved without statistically significant differences between the two groups. Conclusions: Both finasteride and hydroxychloroquine are equally effective, safe, and well‐tolerable for treating FFA patients. [ABSTRACT FROM AUTHOR]

Introduction: Androgenic alopecia (AGA) is the most common cause of hair loss in women, affecting their quality of life. The present study was conducted with the aim of comparing the combined effect of topical minoxidil and oral spironolactone with the combined effect of topical minoxidil and oral finasteride in women with AGA, female and male hair loss patterns. Method: This clinical study was performed on 60 women suffering from AGA. The patients were divided into two groups receiving spironolactone 100 mg/day and finasteride 5 mg/day. In addition, a 2% minoxidil solution was used in all patients in addition to treatment with finasteride or spironolactone. At 2 months after initiation and at the end of treatment, patients were evaluated using the Ludwig/Norwood–Hamilton scale and the degree of physician and patient satisfaction. Results: After 2 months, hair density, hair thickness, and hair loss had improved in both groups; however, statistically, there was no significant difference between the two groups with respect to these parameters (p > 0.05). After 4 months, a significant difference was found between the two groups in terms of treatment response (physician satisfaction), hair density, and hair loss severity. So that, the drugs used were ineffective in 6.7% of cases in the minoxidil‐spironolactone group and in 16.7% of cases in the minoxidil‐finasteride group. In addition, 43.3% of cases in the minoxidil‐spironolactone group and 53% in the minoxidil‐finasteride group responded well to treatment. The treatment effect was excellent in 56.7% and 0% of the mentioned groups, respectively, and the mentioned difference was statistically significant (p: 0.01). The response to treatment in female pattern hair loss (FPHL) was not statistically significant (p: 0.52), but there was a significant difference in the response to both treatments in male pattern hair loss (MPHL; p: 0.007). In terms of patient satisfaction, minoxidil‐spironolactone treatment was significantly better than minoxidil‐finasteride regarding hair density and severity of hair loss (p: 0.01). Finally, in terms of treatment complications, the patients in two groups did not have any serious adverse effects. Conclusion: The combination of minoxidil and spironolactone could be considered a more effective treatment than the combination of minoxidil and finasteride in women with AGA, FPHL, and MPHL. [ABSTRACT FROM AUTHOR]

Purpose: Topical minoxidil (MNX) 2%–5% and oral finasteride (F) 1 mg/day are the only two pharmacological treatments authorized for androgenetic alopecia (AGA). Recently, a 2.2 mg/mL topical formulation of F was developed to minimize the systemic adverse effects associated with the oral formula. MNX and F act through different mechanisms; therefore, their association could improve clinical efficacy. To evaluate the efficacy of the association of 5% MNX and 0.25% topical F compared to their use in monotherapy, a 6‐month, prospective, randomized, assessor‐blinded trial was conducted. Patients and Methods: Forty‐two males, mean age 24 ± 3 years, with AGA (I–VII of Norwood‐Hamilton Grading Scale), treatment naive or free from any therapy for at least 6 months, were enrolled and randomly assigned to three arm treatment groups (2:1:1): group A (n = 19, the subjects applied 5% MNX in the morning and F spray in the evening), group B (n = 12, the subjects applied F spray in the evening), and group C (n = 11, the subjects applied 5% MNX twice daily). The efficacy of treatments was evaluated at baseline and after 3 and 6 months using a global photography score (GPAS; from −3 to +3) and trichoscopy evaluation and assessed by an investigator unaware of treatment allocation. At baseline and after treatments, the serum levels of follicle‐stimulating hormone (FSH), luteinizing hormone (LH), dehydroepiandrosterone sulfate (DHEA‐S), and testosterone were also evaluated. Results: All treatments resulted in an increase in hair density compared to baseline. However, this improvement was significant only for group A (MNX + F), both at three (+56 density/cm2, p < 0.05) and six (+81 density/cm2, p < 0.001) months. The mean change from baseline in hair density was higher for group A compared to other groups and statistically different compared to group B (F) (p < 0.01), both after 3 and 6 months. Group A showed a global photographic assessment score (GPAS) significantly higher compared to group B (p < 0.001) and group C (p < 0.05) both at 3 and 6 months (2.0 ± 0.7 vs. 0.6 ± 0.8 and 1.3 ± 0.6; respectively). A significantly greater percentage of subjects in Group A achieved a GPAS score of ≥2 in comparison with Groups B and C both after 3 and 6 months (79% vs. 8% and 41%, respectively). No significant differences were observed in mean hair diameter and hormonal levels between the three groups. Good tolerability was observed in all treated groups. Conclusion: The association of 5% MNX lotion and 0.25% F in spray formulation in patients with AGA showed a significantly higher clinical and instrumental efficacy compared to the monotherapies, with comparable tolerability and safety profile. [ABSTRACT FROM AUTHOR]

Background: Minoxidil and the 5‐alpha reductase inhibitors (5‐ARIs), specifically, dutasteride and finasteride, are usually used to treat pattern hair loss (PHL), but evidence on the relative effectiveness of these drugs is far less for women than men. Aims: We performed an age‐adjusted network meta‐analysis (NMA) to determine the comparative efficacy of monotherapy with the three agents—in any dosage and administrative route—on PHL in adult women. Methods: The peer‐reviewed literature was systematically reviewed to obtain data for our NMA. The outcome measure for our NMA was "change in total hair density." We referred to "regimen" as an "agent and its dosage;" our Bayesian NMA estimated regimens' surface under the cumulative ranking curve (SUCRA) values and pairwise relative effects. Results: Our NMA used data from 13 trials—across which the following 10 regimens were identified (in decreasing order of SUCRA): 5 mg/day finasteride for 24 weeks (SUCRA = 95.7%), 5% topical minoxidil solution twice daily for 24 weeks (SUCRA = 89.5%), 1 mg/day minoxidil for 24 weeks (SUCRA = 78.1%), 5% topical minoxidil foam 1 half capful/day for 24 weeks (SUCRA = 66.5%), 3% topical minoxidil solution 1 mL twice daily for 24 weeks (SUCRA = 45.1%), 2% topical minoxidil solution 1 mL twice daily for 24 weeks (SUCRA = 44.6%), 5% topical minoxidil solution 1 mL/day for 24 weeks (SUCRA = 41.7%), 0.25 mg/day minoxidil for 24 weeks (SUCRA = 35.5%), 1.25 mg/day finasteride for 24 weeks (SUCRA = 24.8%) and 1 mg/day finasteride for 24 weeks (SUCRA = 4.3%). Conclusion: Our findings can improve clinical guidelines and help dermatologists manage female PHL more optimally with the available options. [ABSTRACT FROM AUTHOR]

Hair loss may change the quality of life since modern society considers hair an essential element in beauty definition. The most common causes of hair loss are androgenetic alopecia (AGA) and telogen effluvium (TE). AGA requires a lifetime use of minoxidil or finasteride (and sometimes they lose efficacy over the years), whereas TE has no standardized therapy available. Our study focuses on a novel topical regenerative preparation that, by mimicking autologous PRP, can safely and efficiently improve hair loss in patients affected by TE and AGA. [ABSTRACT FROM AUTHOR]

Benign prostatic hyperplasia (BPH) is the most common adenoma in old men. Tomatoes are a rich source of bioactive compounds that, as well as selenium (Se), possess antioxidant and antiproliferative activity. The aim was to evaluate the therapeutic effect of Se in combination with a tomato extract in aged rats with BPH. Aged male Wistar rats were divided in the following groups (n = 10 rats/group): Control (C), BPH, BPH + Finasteride (BPH + F), BPH + Tomato Lipidic Extract (BPH + E), BPH + Selenium (BPH + S) and BPH plus E plus S (BPH + E + S). After 4 weeks of treatment, prostate weight, diuresis, antioxidants enzymes, prooxidants and inflammatory markers, growth factors and androgens were determined. BPH + E + S reduced prostate weight by 59.29% and inhibited growth by 99.35% compared to BPH + F which only decreased weight and inhibited growth by 15.31% and 57.54%, respectively. Prooxidant markers were higher with BPH + F (49.4% higher vs. BPH), but BPH + E + S decreased these markers (94.27% vs. BPH) and increased antioxidant activity. Finally, diuresis was higher with the BPH + E + S combination and markers of inflammation and growth factors were significantly lower with respect to BPH + F. Our findings provide a beneficial and protective therapeutic option of E + S directed against androgens, oxidative stress and inflammation that regulates cell proliferation in the prostate gland. [ABSTRACT FROM AUTHOR]

The article discusses a study on the risk of psychiatric disorders in individuals using finasteride for benign prostatic hyperplasia (BPH) and androgenetic alopecia (AGA). The study methodology is described as a retrospective cohort study rather than a case-control study, with concerns raised about the choice of controls impacting the study's conclusions. The authors emphasize the importance of accurately identifying and reporting study methodologies to avoid confusion and bias in research findings. The article highlights the need for thorough assessment and reporting of study methodologies to ensure confidence in research outcomes. [Extracted from the article]

Objective: Treatment of frontal fibrosing alopecia (FFA) is complicated and challenging. In this study, we evaluated the efficacy of combining topical tacrolimus with isotretinoin versus finasteride in patients with FFA. Methodology: Thirty‐one patients with FFA were divided randomly into two groups. Therapeutic regimen of the first group (group A, n = 16) was isotretinoin and tacrolimus (Capsule isotretinoin 20 mg daily and topical tacrolimus 0.1% BD). The second group (group B, n = 15) was given finasteride and tacrolimus (Tablet finasteride 2.5 mg daily and topical tacrolimus 0.1% BD). Patients were treated and followed up periodically for 12 weeks. Evaluation of the treatment efficacy was based on Patient Global Assessment and Physician Global Assessment scales. Objective evaluation was based on improving the severity of skin lesions by viewing serial images taken from the affected areas. Results: Physician Global Assessment (PGA) was significantly better in the group A as compared with the group B at 4 weeks (p = 0.038). Physician satisfaction in the group A was better than the group B at 12 weeks, but this was not statistically significant (p > 0.05). Patient Global Assessment and patient satisfaction in the group A was better than the group B at 8 and 12 weeks, but it was not statistically significant (p > 0.05). Conclusion: Although both therapeutic regimens were effective in the treatment of FFA, treatment with tacrolimus and isotretinoin is significantly more effective than tacrolimus and finasteride. [ABSTRACT FROM AUTHOR]

Background: Oral finasteride is an FDA‐approved treatment for androgenetic alopecia (AGA). Topical finasteride, while not FDA‐approved, lacks the systemic adverse effects associated with oral finasteride. The efficacy of topical finasteride has been evaluated. Aim: To review whether topical finasteride is a safe and effective treatment for male and female pattern hair loss. Method: A structured search in PubMed and Google Scholar identified 864 records, with 32 articles meeting the inclusion criteria for review. Results and discussion: In a phase III, randomized, controlled trial, the efficacies of topical 0.25% w/w finasteride spray (1–4 sprays; 50–200 μl/day) and once‐daily finasteride 1 mg oral tablet were similar when administered for 24 weeks (mean change from baseline, 20.2 vs. 21.1 hairs/cm2). Additionally, a double‐blind, randomized trial compared the efficacies of twice‐daily finasteride 1% topical gel and once‐daily finasteride 1 mg oral tablet for 6 months, and found similar results in both groups. Moreover, a combination of topical minoxidil and topical finasteride may enhance efficacy. Topical finasteride reduces both scalp and plasma DHT levels. In an open‐label pharmacodynamic study, a 7‐day treatment of twice‐daily finasteride 0.25% topical solution and once‐daily finasteride 1 mg oral tablet provided similar inhibition of plasma DHT. Topical finasteride reduces the potential for systemic side effects, including the risk of sexual dysfunction. The side effects are localized to the application site, for example, scalp pruritus, burning sensation, irritation, contact dermatitis, and erythema. Conclusion: Topical finasteride may be an alternative for those concerned about the oral formulation's systemic side effects. [ABSTRACT FROM AUTHOR]

Background: 5α‐reductase inhibitors are commonly prescribed medications with multiple side effects used in the treatment of male pattern hair loss and benign prostatic hyperplasia. These side effects including "post‐finasteride syndrome" may result in lawsuits. Objectives: To characterize lawsuits involving the adverse side effects of 5α‐reductase inhibitor to better understand drivers of litigation and outcomes. Methods: Legal cases were queried from Nexis Uni using the search terms "5‐alpha reductase inhibitor" as well as specific agents "finasteride," "dutasteride" in combination with "malpractice," "negligence," "damage," "loss," "side effect," and "complication." Secondary review was performed with publicly available data on "In Re: Propecia." Relevant cases were reviewed and pertinent characteristics were extracted and summarized using descriptive statistics. Results: Our search yielded 156 unique legal cases in the Nexis Uni database from April 2003 to May 2021. Only 18 of these cases met the inclusion criteria. Adverse events experienced by patients included medication side effects (n = 12, 66.7%), delayed cancer diagnosis (n = 3, 16.7%), and lack of symptom improvement (n = 3, 16.7%). The identity of the plaintiffs were most commonly patients themselves (n = 15, 83.3%). Defendants include pharmaceutical companies (n = 6, 33.3%), a combination of parties (n = 5, 27.8%), and physicians (n = 5, 27.8%) alone. The allegations included sexual side effects such as erectile dysfunction (n = 6, 33.3%) and decreased libido (n = 4, 22.2%). These prescriptions were made for benign prostatic hyperplasia (n = 9, 50%), male pattern hair loss (n = 7, 38.9%), and feminizing hormone therapy (n = 2, 11.1%). Several of these cases involved the same plaintiffs in related cases. No verdicts were against physicians. We noted a largely settled lawsuit involving more than 1000 plaintiffs with limited data on harms alleged and a $4.3 million settled amount. Of the total cases that resulted in a verdict, 9/18 were within the last 3 years. Discussion: The most common complications experienced by patients in our legal review were those involving sexual dysfunction with erectile dysfunction and decreased libido. The growing number of cases in the later years of our review suggests litigation may continue to increase in the coming future. Our review did not identify any individual cases that resulted in a monetary payout beyond a $4.3 million settlement outside of court. Conclusion: 5α‐reductase inhibitor was alleged to have sexual, mental, and physical side effects, resulting in legal litigation. Despite this, no judgment against a physician or pharmaceutical company was identified. We do note and discuss a large number of lawsuits settled out of court. Given the increase in the number of lawsuits resulting in verdicts over the last 3 years, we suspect that the frequency of litigation around 5α‐reductase inhibitors will continue for the foreseeable future. [ABSTRACT FROM AUTHOR]

Background: Oral finasteride is a well‐established treatment for men with androgenetic alopecia (AGA), but long‐term therapy is not always acceptable to patients. A topical finasteride formulation has been developed to minimize systemic exposure by acting specifically on hair follicles. Objectives: To evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride. Methods: This randomized, double‐blind, double dummy, parallel‐group, 24‐week study was conducted in adult male outpatients with AGA at 45 sites in Europe. Efficacy and safety were evaluated. Finasteride, testosterone and dihydrotestosterone (DHT) concentrations were measured. Results: Of 458 randomized patients, 323 completed the study and 446 were evaluated for safety. Change from baseline in target area hair count (TAHC) at week 24 (primary efficacy endpoint) was significantly greater with topical finasteride than placebo (adjusted mean change 20.2 vs. 6.7 hairs; P < 0.001), and numerically similar between topical and oral finasteride. Statistically significant differences favouring topical finasteride over placebo were observed for change from baseline in TAHC at week 12 and investigator‐assessed change from baseline in patient hair growth/loss at week 24. Incidence and type of adverse events, and cause of discontinuation, did not differ meaningfully between topical finasteride and placebo. No serious adverse events were treatment related. As maximum plasma finasteride concentrations were >100 times lower, and reduction from baseline in mean serum DHT concentration was lower (34.5 vs. 55.6%), with topical vs. oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride. Conclusion: Topical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and less impact on serum DHT concentrations. [ABSTRACT FROM AUTHOR]

Solid‐state ECD (ss‐ECD) spectra of a model microcrystalline solid, finasteride, dispersed into a KCl pellet were recorded by using the synchrotron radiation source at the Diamond B23 beamline. Scanning a surface of 36 mm2 with a step of 0.5 mm, we measured a set of ECD imaging (ECDi) spectra very different from each other and from the ss‐ECD recorded with a bench‐top instrument (1 cm2 area). This is due to the anisotropic part of the ECD (ACD), which averages to zero in solution or on a large number of randomly oriented crystallites, but can otherwise be extremely large. Two‐way singular value decomposition (SVD) analysis, through experimental and simulated TDDFT spectra, disclosed that the measured and theoretical principal components are in line with each other. This finding demonstrates that the observed isotropic ss‐ECD spectrum is governed by the anisotropy of locally oriented crystals. It also introduces a new quality for ss‐ECD measurements and opens a new future for probing and mapping chiral materials in the solid state such as active pharmaceutical ingredients (APIs). [ABSTRACT FROM AUTHOR]

Background: There is a long-standing debate if finasteride, a medication used to treat benign prostatic hyperplasia (BPH) and androgenetic alopecia (AGA), can cause psychiatric side effects., Objective: The goal of this large-scale population-based study was to determine whether finasteride therapy for BPH and AGA is associated with the emergence of mental health conditions., Methods: This observational case-control study compared the data from patients with BPH who received finasteride 5 mg daily and patients with AGA who received finasteride 1 mg daily with age- and gender-matched controls. The incidence of psychological health outcomes such as depression, anxiety, neuroses, bipolar disorder, schizophrenia, psychoses and alcohol abuse within 2 years of the initiation of finasteride therapy has been evaluated and compared between the finasteride groups and controls., Results: The BPH group included 307 men with a mean age of 61.5 (±17.4) years and 1218 controls. Mental health outcomes recorded in 2.3% of the patients, with no significant increase in rate when compared to controls. The AGA group consisted of 23,227 men with a mean age of 31.4 (±10.3) years and 39,444 controls. Only One percent of AGA patients developed psychiatric disorders. In comparison to controls, patients with AGA had higher rates of anxiety and depression (0.6% vs. 0.4%, p = 0.04, and 0.5% vs. 0.4%, p = 0.007, respectively). In multivariate regression models, finasteride was found as one of the risk factors for anxiety (OR 1.449, p = 0.002) and depression (OR 1.439, p = 0.003) when stratified to age, sector, socioeconomic status and comorbidities., Conclusions: According to our research, finasteride users had a very low rate of adverse mental health effects, with no increase in psychological sequelae in BPH patients and a slight increase in anxiety and depression in AGA patients., (© 2024 Australasian College of Dermatologists.)

Background: Acne is a chronic inflammatory skin disease which involves the pilosebaceous unit. Tissue inflammation isone of the crucial mechanisms, amongst others. Of the various cytokines, leukotriene B4 (LT‐B4) is the most potentleucocyte chemotactic mediator. Montelukast is an antagonist of the LT‐B4 receptor. Finasteride is an antiandrogen whichspecifically inhibits the 5α‐reductase enzyme. Aims: This study aimed at comparing the efficacy, tolerability and safety of montelukast versus finasteride in the treatmentof moderate acne in women. Patients/Method: This randomized, single‐blinded, prospective trial over 12 weeks recruited 65 female subjects with moderate acne vulgaris (Global Acne Grading System Scale) for evaluation. One group (n = 30) received oral montelukast (10 mg PO daily), while the second group (n = 25) received oral finasteride (2.5 mg PO daily) in combination with topical clindamycin 2% solution. Lesion count and acne severity were evaluated at time intervals of 0 (baseline), 4, 8, and 12 weeks. Adverse effects of the drugs were noted. Results: Both lesion count and severity of acne decreased significantly after treatment in both the groups as compared to the baseline. The acne severity score reached from 33.93 in time zero to 20.6 in the 12th week and 35.71 at baseline to 16.43 at the end of treatment in the Montelukast and Finasteride groups, respectively. Side effects were noted in 3 patients and 2 patients in the monteleukast and finasteride group, respectively, which were transient and non‐serious in nature proving the satisfactory tolerability and safety of these two drugs. Conclusion: The results of this study show that both montelukast and finasteride have good efficacy in the treatment of acne. Finasteride has more efficacy than montelukast for treating moderate acne in normo‐androgenic women. [ABSTRACT FROM AUTHOR]

Background: Low dose (<5 mg) oral minoxidil (OM) seems a promising option for male androgenetic alopecia (MAGA). Aim: To evaluate the role of oral minoxidil 1.25 mg versus oral minoxidil 2.5 mg along with platelet‐rich plasma in MAGA. Methods: Group A consisted of forty‐seven patients which included patients on OM 1.25 mg daily and platelet‐rich plasma therapy, and Group B consisted of 48 patients on OM 2.5 mg daily and platelet‐rich plasma therapy. Photographs were taken before and after treatment along with trichoscopic evaluation. Selection of the dermoscopic variables was based on the published literature. Results: At 24 weeks, marked improvement on Global clinical photography (GCP) were seen in 19/47 (40.4%) in Group A and 28/48 (58.3%) patients in Group B with p value of 0.058. The total increase in total hair/cm2 was around 24 and 36 in group A and B, respectively, with p > 0.05. The percentage increase in mean total hair count/cm2 after 6 month of treatment was 15.41% in group A and 22.15% in group B, but they were not statistically significant. The patient satisfaction score on a Likert scale between both group were statistically significant,with Group B patients having a better satisfaction score. Conclusion: This is a pilot study where OM along with PRP at different dosage (1.25mg vs 2.5mg) has been compared, low dose OM with PRP can be used in patients who are apprehensive of taking finasteride or dutasteride and are less responsive to topical minoxidil alone. [ABSTRACT FROM AUTHOR]

BACKGROUND: Androgen deprivation therapy (ADT) improves outcomes in unfavorable‐risk prostate cancer (PCa) treated with radiation therapy (RT). It was hypothesized that replacing luteinizing hormone‐releasing hormone (LHRH) agonists with a 5‐α‐reductase inhibitor (5‐ARI) would improve hormonal health‐related quality of life (HRQOL) without differentially suppressing androgen‐responsive (AR) gene expression. METHODS: Patients with localized unfavorable‐risk PCa, aged ≥70 years or Charlson Comorbidity Index score ≥2 were treated with oral ADT (oADT), consisting of 4 months of bicalutamide, a 5‐ARI, and RT at 78 Gy. The primary end point was Expanded Prostate Cancer Index Composite HRQOL at 6 months ≤30%, and improvement compared with a synchronous standard of care (SOC) cohort receiving 4 months of bicalutamide and long‐term LHRH agonist with RT. RNA sequencing was performed from matched pre‐/post‐ADT prostate tumor biopsies in a subset of men. Differential gene and pathway expressional changes were examined using gene set enrichment. RESULTS: Between 2011 and 2018, 40 and 30 men were enrolled in the oADT and SOC cohorts, respectively. Median follow‐up was 40 months. Those with ≤30% decline in hormonal HRQOL at 6 months was 97% (oADT) and 93% (SOC). The average 6‐month hormonal decline was 1% (oADT) versus 12% (SOC; P =.04). The 4‐year freedom from biochemical failure was 88% (oADT) versus 81% (SOC; P =.48). RNA sequencing (n = 9) showed similar numbers of downregulated and upregulated genes between the treatment groups (fold‐change = 2; false‐discovery rate‐adjusted P ≤.05). Both treatments comparably decreased the expression of 20 genes in canonical androgen receptor signaling. CONCLUSIONS: For men with PCa undergoing RT, oral versus standard ADT may improve 6‐month QOL and appears to have a similar impact on androgen‐responsive gene expression. For men with localized prostate cancer undergoing radiation therapy, oral versus standard androgen deprivation therapy may improve 6‐month quality of life and appears to have a similar effect on androgen‐responsive gene expression. [ABSTRACT FROM AUTHOR]

The aim of the current study was to investigate antioxidant, anti‐inflammatory and anti‐apoptotic effects of Origanum vulgare on finasteride‐induced oxidative injury in mouse testis and sperm parameters. Thirty BALB/c mice were divided into 5 groups: negative control, received 0.5 ml/day distilled water; positive control, received 25 mg/kg finasteride orally; and three groups received 100, 200 and 400 mg/kg/day O. vulgare extract plus 25 mg kg−1 day−1 finasteride for 35 days. At day 36, serum luteinising hormone, follicle‐stimulating hormone and testosterone, inflammatory cytokines (IL‐6, TNF‐α, IL‐1β), glutathione peroxidase, superoxide dismutase and nitric oxide levels were assessed. Also, apoptotic changes investigated through genes expression and immunohistochemical staining. Finasteride in 35 days resulted in significant destructive alterations in the testis architecture, suppressed antioxidant enzymes and increased lipid peroxidation. The expression of Bcl‐2 was down‐regulated, whereas p53 and caspase‐3 were up‐regulated. Origanum vulgare improved the serum level of hormones and restored the antioxidant defence. 200 and 400 mg/kg/day of O. vulgare alleviated the testis structure and sperm parameters, up‐regulated the anti‐apoptotic gene Bcl‐2 and down‐regulated the p53, caspase‐3 genes in treated groups. The findings indicate that O. vulgare extract improved function and structure of testis tissue against finasteride‐induced testicular toxicity. [ABSTRACT FROM AUTHOR]

Protocatechuic acid (PA) is a polyphenol—recognized for its efficacy as an antioxidant—possesses anticancer, anti‐inflammatory, antioxidant properties. The efficacy of PA in the management of benign prostatic hyperplasia (BPH) has not been investigated. Forty‐two castrated rats (n = 7) were treated as follows: control (corn oil), BPH only received testosterone propionate (TP) (TP 3 mg/kg intraperitoneally), BPH + PA (TP 3 mg/kg + PA 40 mg/kg), BPH + finasteride (Fin) (TP 3 mg/kg + Fin 10 mg/kg), PA only (40 mg/kg: by gavage), and Fin only (10 mg/kg: by gavage) for 4 weeks. In BPH rats, there were significant (P <.05) increases in prostatic (250%) and organosomatic (280%) weights compared with controls. Cotreatment decreased prostatic weights by 19% (PA) and 21% (Fin). Markers of inflammation: myeloperoxidase activities increased in serum (148%) and prostate (70%), as well as nitric oxide levels serum (92%) and prostatic (95%). Proinflammatory cytokines interleukin‐1β and tumor necrosis factor‐α increased by 3.6‐ and 2.8‐fold. Furthermore, prostatic malondialdehyde, superoxide dismutase, and serum total acid phosphatase increased by 97%, 25%, and 48%, respectively. Histology revealed poor architecture and severe proliferation of the prostate in BPH rats. Inflammation and oxidative stress markers, as well as the histological alteration in BPH rats, was attenuated (P <.05) upon cotreatment with PA and comparable with Fin cotreatment. These results suggest that PA mitigates oxido‐inflammatory responses and restored prostatic cytoarchitecture to levels comparable with control in rats induced with BPH. [ABSTRACT FROM AUTHOR]

Background: Drug trials for male‐pattern hair loss (MPHL) did not investigate hair cycling. Materials and Methods: Male‐pattern hair loss volunteers (n = 22) took oral finasteride 1 mg daily with randomly either MTS5% or control lotion (1 mL/d). After 12 months on oral drug, 14 were randomized for a dose‐effect study of topical minoxidil 2% or 5%. Each 3‐month "on‐lotion" was followed by a 3‐month "off‐lotion." Results: Exogen release and anagen initiation from pre‐existing but functionally deficient follicles occurred mainly during combined dug treatment. Anagen initiation by topical minoxidil 5% could not be maintained by oral finasteride. As compared with control males, the compound index of hair growth raised from 30% at baseline up to 60% within 3 months of combined drug regimen which is better than oral drug only (no change) but still far beyond normalization of productivity (considered as 100%). There was no obvious transformation of miniaturized hair follicles into terminal hair‐producing follicles, and the activation of miniaturized hair follicles was not clinically relevant (slow growth and short duration of anagen). Conclusions: Benefit with oral finasteride and topical 5% minoxidil (1 mL, 1 per day) resulted from initiation of anagen in deficient terminal follicles without increased growth rates. [ABSTRACT FROM AUTHOR]

The development and maintenance of prostate function depend on a fine balance between oestrogen and androgen levels. Finasteride inhibits 5α‐reductase, which is responsible for the conversion of testosterone into its most active form, dihydrotestosterone. Enzymes that metabolize these hormones have a highly relevant role in both the normal prostate metabolism and in the occurrence of pathological conditions. There are few studies on the impact of finasteride on male prostate development and fewer studies on the female prostate and possible intersexual differences. Therefore, we treated male and female gerbils from 7 to 14 days in postnatal life with a high dose of finasteride (500 μg/kg/day); the prostate complexes were then removed and submitted to immunohistochemistry, immunofluorescence and three‐dimensional reconstruction. In addition, hormonal serum dosages were administered. Treatment with finasteride resulted in an increased thickness of the periductal smooth musculature in the prostate of both male and female gerbils, such as well as a reduction in the thickness of developing prostate alveoli in both sexes. In addition, intersexual differences were observed as increased epithelial proliferation and decreases in the number of developing alveoli in females. Together, the data indicate that postnatal exposure to finasteride causes greater changes in the female gerbil prostate than in the male. [ABSTRACT FROM AUTHOR]

Neurosteroids are potent allosteric modulators of GABAA receptors (GABAARs). Although the effects of exogenous neurosteroids on GABAAR function are well documented, less is known about effects of neurosteroids produced by local endogenous biosynthesis. The neurosteroidogenic enzymes 5α‐reductase and 3α‐hydroxysteroid dehydrogenase are expressed in two nuclei of somatosensory thalamus, the thalamic reticular nucleus (nRT) and ventrobasal nucleus (VB). Here, the effects of acute blockade of neurosteroidogenesis by the 5α‐reductase inhibitor finasteride on phasic and tonic GABAAR‐mediated currents were examined in nRT and VB of mice. In nRT, finasteride altered the decay and amplitude, but not the frequency, of phasic currents, with no effect on tonic inhibition. In VB neurons, by contrast, finasteride reduced both the size and frequency of phasic currents, and also reduced the degree of tonic inhibition. These studies thus provide novel evidence for endogenous modulation of GABAAR function by 5α‐reduced neurosteroids in the mature thalamus. [ABSTRACT FROM AUTHOR]

Benign prostatic hyperplasia (BPH) is a pathology characterised by an increase in prostate size associated with low urinary tract symptoms. Finasteride (F), a 5a‐reductase inhibitor, is the standard treatment for BPH reducing prostate weight but also sexual desire. The Peruvian plant known as Red Maca (RM) (Lepidium meyenii) inhibits BPH in rats and mice. The aim of the study was to assess the inflammatory effect of RM and finasteride in rats with testosterone enanthate (TE)‐induced BPH. Thirty rats were divided into 5 groups: Control, TE (50 mg/rat), TE + F (0.6 mg/kg), and two groups of TE + RM 40/80 (40 or 80 mg). After treatments, tumour necrosis factor alpha (TNFa), interleukin 4 (IL4) and interferon gamma (INFg) as well as testosterone and oestradiol were evaluated and inflammatory cells (neutrophils, mast cells and lymphocytes) in prostate were quantified. Red Maca and finasteride treatments decreased inflammatory cells counts in prostate, inhibiting TNFa by different pathways. Finasteride increased IL4 whereas Red Maca increased INFg. In conclusion, data suggest that finasteride acts on Th2 response by increasing IL4 in prostate, while Red Maca acts on Th1 response mediated by INFg. [ABSTRACT FROM AUTHOR]

Purpose Published epidemiological studies on the association between finasteride use and the risk of male breast cancer have been inconclusive due to methodological limitations including a few male breast cancer cases included. Determinants of male breast cancer have been studied, but it remains unexplored whether these are also related to finasteride use and thereby constitute potential confounders. This study aimed to assess whether there are differences between finasteride users and nonusers with regard to numerous potential confounders. Methods: In total, 246 508 finasteride users (≥35 years) were identified in the prescription registries of Denmark (1995‐2014), Finland (1997‐2013), and Sweden (2005‐2014). An equal number of nonusers were sampled. The directed acyclic graph (DAG) methodology was used to identify potential confounders for the association between finasteride and male breast cancer. A logistic regression model compared finasteride users and nonusers with regard to potential confounders that were measurable in registries and population surveys. Results: Finasteride users had higher odds of testicular abnormalities (odds ratio [OR] 1.40; 95% confidence interval [CI] 1.36‐1.44), obesity (1.31; 1.23‐1.39), exogenous testosterone (1.61; 1.48‐1.74), radiation exposure (1.22; 1.18‐1.27), and diabetes (1.07; 1.04‐1.10) and lower odds of occupational exposure in perfume industry or in high temperature environments (0.93; 0.87‐0.99), living alone (0.89; 0.88‐0.91), living in urban/suburban areas (0.97; 0.95‐0.99), and physical inactivity (0.70; 0.50‐0.99) compared to nonusers. Conclusions: Systematic differences between finasteride users and nonusers were found emphasizing the importance of confounder adjustment of associations between finasteride and male breast cancer. [ABSTRACT FROM AUTHOR]

The prostate is an accessory reproductive gland that is sensitive to the action of exogenous compounds known as endocrine disrupters that alter normal hormonal function. Finasteride is a widely used chemical that acts to inhibit the conversion of testosterone in its most active form, dihydrotestosterone. It is known that intrauterine exposure to finasteride causes changes in the male prostate even at low dosages; however, it is not known whether these dosages are capable of causing changes in the female prostate, which is present in a large number of mammalian species, including humans. In the present study, histochemistry, immunohistochemistry, immunofluorescence, serological dosages, and three‐dimensional reconstruction techniques were employed to evaluate the effects of intrauterine exposure to a low dose of finasteride (100 μg.BW/d) on postnatal prostate development in male and female Mongolian gerbils. The results indicate that the gerbil female prostate also undergoes alterations following intrauterine exposure to finasteride, exhibiting a thickening of periductal smooth muscle and increased stromal proliferation. There are also intersex differences in the impact of exposure on the expression of the androgen receptor, which was increased in males, and of the estrogen‐α receptor, which was decreased in the male prostate but unchanged in females. Altogether, this study indicates there are sex differences in the effects of finasteride exposure even at low dosages. [ABSTRACT FROM AUTHOR]

This commentary will explore the important clinical question regarding whether the antiandrogen class of 5α‐reductase inhibitors should be considered as an effective and safe treatment option for transfeminine and/or transmasculine individuals. The use of finasteride in transfeminine individuals is based upon the theory that the goal of medical treatment is to reduce the concentrations of androgens, including dihydrotestosterone. Nonetheless, it is unclear that finasteride will have any additive clinical benefit once testosterone levels have already been lowered with standard treatment regimens (i.e. estrogen with spironolactone or cyproterone acetate). For transmasculine individuals, 5α‐reductase inhibitors may be a potential treatment option for a subset with androgenetic alopecia but may come at the expense of impairing virilization driven by dihydrotestosterone. In the absence of efficacy and safety data on 5α‐reductase inhibitors in gender diverse populations, clinicians should discuss this issue with patients who request or are contemplating their use. [ABSTRACT FROM AUTHOR]

"Comparison of QR 678® & QR678® Neo as monotherapy and as combination therapy with 5% Minoxidil solution and oral Finasteride in the treatment of male androgenetic alopecia - Which is better?" Keywords: androgenic alopecia; combination therapy; hair regrowth therapy; male pattern hair loss; QR678 EN androgenic alopecia combination therapy hair regrowth therapy male pattern hair loss QR678 1763 1765 3 05/22/21 20210601 NES 210601 CONFLICT OF INTERESTS The authors have been awarded a patent from the United States Patent & Trademark Office (USPTO) & from the Indian Patent Office administered by the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) for the invented hair formulation, used in this study. But when we combined the QR678 SP ® sp intradermal injection therapy with Minoxidil solution and oral Finasteride, combination treatment proved to be more effective in terms of hair regrowth, hair loss, and hair density. [Extracted from the article]

Background: Biopsy‐based "reversal hypothesis" claimed conversion of miniaturized hair follicles into terminal ones for the improvement of male pattern hair loss (MPHL) with FDA‐approved drugs. Materials and methods: MPHL volunteers (n = 13) completed a 24‐month phototrichogram study. After 2 months no‐treatment, panellists took finasteride 1mg daily for 2 years. Hair changes from the best responder would explain the nature of improved hair growth. Results: Due to the wide range of hair growth variables, no parameter was statistically significantly changed by finasteride in the group. Clinically there were 4 worse, 6 no change, 2 slightly and 1 moderately improved subject associated with turning telogen/empty terminal follicles into anagen after 12‐ and 24‐month finasteride. From 113 miniaturized hair (diameters ≤ 30 µm) at baseline, 79 were still miniature hair after 2 years on finasteride. No hair were found at the remaining mapped sites except for 2 terminal hairs considered a probabilistic "uncertainty." Conclusion: Moderate hair improvement resulted from increased productivity of deficient terminal follicles, but not yet irreversibly affected at baseline without implication of miniaturized hair follicles. The latter further regressed even with oral intake of finasteride. The data suggest the rejection of the "reversal hypothesis" unless proven otherwise with duly validated methods. [ABSTRACT FROM AUTHOR]

Clinical and animal studies have revealed sex‐specific differences in histopathological and neurological outcome after traumatic brain injury (TBI). The impact of perioperative administration of sex steroid inhibitors on TBI is still elusive. Here, we subjected male and female C57Bl/6N mice to the controlled cortical impact (CCI) model of TBI and applied pharmacological inhibitors of steroid hormone synthesis, that is, letrozole (LET, inhibiting estradiol synthesis by aromatase) and finasteride (FIN, inhibiting dihydrotestosterone synthesis by 5α‐reductase), respectively, starting 72 h prior CCI, and continuing for a further 48 h after CCI. Initial gene expression analyses showed that androgen (Ar) and estrogen receptors (Esr1) were sex‐specifically altered 72 h after CCI. When examining brain lesion size, we found larger lesions in male than in female mice, but did not observe effects of FIN or LET treatment. However, LET treatment exacerbated neurological deficits 24 and 72 h after CCI. On the molecular level, FIN administration reduced calpain‐dependent spectrin breakdown products, a proxy of excitotoxicity and disturbed Ca2+ homeostasis, specifically in males, whereas LET increased the reactive astrocyte marker glial fibrillary acid protein specifically in females. Examination of neurotrophins (brain‐derived neurotrophic factor, neuronal growth factor, NT‐3) and their receptors (p75NTR, TrkA, TrkB, TrkC) revealed CCI‐induced down‐regulation of TrkB and TrkC protein expression, which was reduced by LET in both sexes. Interestingly, FIN decreased neuronal growth factor mRNA expression and protein levels of its receptor TrkA only in males. Taken together, our data suggest a sex‐specific impact on pathogenic processes in the injured brain after TBI. Sex hormones may thus modulate pathogenic processes in experimental TBI. [ABSTRACT FROM AUTHOR]

Background: The occurrence of sexual dysfunction side‐effects associated with finasteride use in men with androgenetic alopecia (AGA) is thought to be less prevalent than is publicized. There is a need to investigate sexual dysfunction among finasteride users with population‐based controls. Objective: To evaluate the presence of sexual dysfunction in men using finasteride or not using finasteride. Method: Adult men visiting a dermatologist's office for any reason were asked to complete a survey including a modified version of the Arizona Sexual Experience Scale (ASEX) to assess the presence of sexual dysfunction with and without finasteride use. Results: Data from 762 men aged 18–82 were collected: 663 finasteride users and 99 non‐finasteride users. There were no significant differences between finasteride users and non‐user controls in reporting sexual dysfunction using the ASEX. Regression analysis indicated that self‐reporting libido loss and reduced sexual performance, not finasteride use, predict a higher ASEX score. Conclusion: The use of finasteride does not result in sexual dysfunction in men with AGA. These data are consistent with other large survey‐based controlled studies. [ABSTRACT FROM AUTHOR]

Background: Physicians are beginning to use finasteride as treatment for hair loss, hirsutism, and various other dermatologic conditions in women. However, the reported efficacy and use of finasteride in the female population varies widely. The purpose of this study is therefore to better define the efficacy and use of finasteride in women and identify research gaps that require further investigation. Methods: A systematic review of the current literature describing finasteride use in women. Results: A total of 2,683 patients participated in 65 studies involving finasteride use in women published between January 1997 and July 2017. Most randomized controlled trials (RCTs) evaluated finasteride use in women with hirsutism (48.7%) or female pattern hair loss (34.7%). RCTs recommend finasteride treatment for women with hirsutism or polycystic ovarian syndrome. Meanwhile, other forms of hair loss were studied such as alopecia, lichen planopilaris, and frontal fibrosing alopecia, but no RCTs evaluating finasteride therapy were identified. Other prospective and retrospective studies report that finasteride may improve hair loss in women with female pattern hair loss or frontal fibrosing alopecia. Overall, doses of oral finasteride ranged from 0.5 to 5 mg/day, in females aged 6–88, over a duration of 6–12 months (57.6%), as monotherapy (88.9%), and for continuous use (96.4%). Conclusion: The studies reviewed highlight the finasteride dosage, length of treatment, and candidate conditions that can benefit from finasteride therapy. Future long‐term studies are necessary to fully assess the therapeutic mechanisms and potential consequences of finasteride use and to optimize treatment protocols. [ABSTRACT FROM AUTHOR]

Objective: To investigate the use of 5α‐reductase inhibitors (5ARIs) and α‐blockers among men with benign prostatic hyperplasia (BPH) in relation to prostate cancer (PCa) incidence, severity and mortality. Patients and Methods: A retrospective 20‐year cohort study in men residing in Saskatchewan, aged 40–89 years, with a BPH‐coded medical claim between 1995 and 2014, was conducted. Cox proportional hazards regression was used to compare incidence of PCa diagnosis, metastatic PCa, Gleason score 8–10 PCa, and PCa mortality among 5ARI users (n = 4 571), α‐blocker users (n = 7 764) and non‐users (n = 11 677). Results: In comparison with both non‐users and α‐blocker users, 5ARI users had a ~40% lower risk of a PCa diagnosis (11.0% and 11.4% vs 5.8%, respectively), and α‐blocker users had an 11% lower risk of a PCa diagnosis compared with non‐users. Overall, the incidence of metastatic PCa and PCa mortality was not significantly different among 5ARI or α‐blocker users compared with non‐users (adjusted hazard ratios [HR] of metastatic PCa: 1.12 and 1.13, respectively, and PCa mortality: 1.11 and 1.18, respectively, P > 0.05 for both drugs), but both 5ARI and a‐blocker users had ~30% higher risk of Gleason score 8–10 cancer, adjusted HR 1.37, 95% confidence interval [CI] 1.03–1.82, P = 0.03, and adjusted HR 1.28, 95% CI 1.03–1.59, P = 0.02, respectively compared with non‐users. Conclusion: The use of 5ARIs was associated with lower risk of PCa diagnosis, regardless of comparison group. Risk of high grade PCa was higher among both 5ARI users and α‐blocker users compared with non‐users; however, this did not translate into higher risk of PCa mortality. [ABSTRACT FROM AUTHOR]

Finasteride 1 mg is considered to be the standard treatment method for male androgenetic alopecia (AGA). However, there have only been a few studies investigating its long‐term efficacy. Moreover, its effect on various types of AGA remains unknown. In this study, the authors investigated the 5‐year efficacy of finasteride 1 mg in Korean men with AGA and analyzed the changes in hair growth according to the distribution of hair loss. The medical records of male AGA patients who were treated with oral finasteride for a period of at least 5 years at two university hospitals were retrospectively reviewed. Patients' photographs were evaluated using the basic and specific (BASP) classification and investigator's global assessment. Of the total 126 patients, 108 (85.7%) showed improvement after 5 years of treatment. According to the BASP classification, hair loss of the anterior hair line (basic type), vertex (V type), and frontal area (F type) was improved in 44.4%, 89.7% and 61.2% of patients, respectively. The V type showed a more rapid and steady improvement compared with the other types. Progression of alopecia after peak improvement was seen in 10.3% of cases of the V type, 16.2% of the F type and 0% of the basic type. In conclusion, finasteride 1 mg showed a sustainable effect for at least 5 years in Korean male AGA patients. The exact time points showing signs of first clinical improvement and sustainability were different depending on the type of alopecia. [ABSTRACT FROM AUTHOR]

Background: The synergism of combined use between oral finasteride and topical minoxidil has been established in treating androgenetic alopecia among men. However, the concern regarding adverse effects of finasteride use has been rising. Objective: To compare the efficacy and safety of topical solution of 0.25% finasteride admixed with 3% minoxidil vs. 3% minoxidil solution in men with androgenetic alopecia. Methods: Forty men aged 18–60 years with androgenetic alopecia were randomized to 24 weeks of treatment with a finasteride/minoxidil or minoxidil solution twice daily. Primary efficacy endpoint was the change from baseline in hair density and hair diameter at week 24. Secondary endpoints included global photographic assessment by treatment‐blinded investigators and subjects. Changes in plasma dihydrotestosterone levels and adverse events were recorded. Results: At week 24, the combined solution of finasteride and minoxidil was significantly superior to minoxidil alone in improvements of hair density, hair diameter and global photographic assessment (all P < 0.05). About 90% of patients treated with the combined solution experienced moderate to marked improvement. The combined solution also had minimal effect on plasma dihydrotestosterone levels, approximately 5% reduction. There were also no systemic adverse events reported by patients in both groups. Conclusion: Treatment with topical solution of 0.25% finasteride admixed with 3% minoxidil was significantly superior to 3% minoxidil solution for promoting hair growth in male androgenetic alopecia, and well tolerated. [ABSTRACT FROM AUTHOR]

Androgenetic alopecia, or male/female pattern baldness, is the most common type of progressive hair loss disorder. The aim of this study was to review recent advances in non‐surgical treatments for androgenetic alopecia and identify the most effective treatments. A network meta‐analysis (NMA) was conducted of the available literature of the six most common non‐surgical treatment options for treating androgenetic alopecia in both men and women; dutasteride 0.5 mg, finasteride 1 mg, low‐level laser therapy (LLLT), minoxidil 2%, minoxidil 5% and platelet‐rich plasma (PRP). Seventy‐eight studies met the inclusion criteria, and 22 studies had the data necessary for a network meta‐analysis. Relative effects show LLLT as the superior treatment. Relative effects show PRP, finasteride 1 mg (male), finasteride 1 mg (female), minoxidil 5%, minoxidil 2% and dutasteride (male) are approximately equivalent in mean change hair count following treatment. Minoxidil 5% and minoxidil 2% reported the most drug‐related adverse events (n = 45 and n = 23, respectively). The quality of evidence of minoxidil 2% vs. minoxidil 5% was high; minoxidil 5% vs. placebo was moderate; dutasteride (male) vs. placebo, finasteride (female) vs. placebo, minoxidil 2% vs. placebo and minoxidil 5% vs. LLLT was low; and finasteride (male) vs. placebo, LLLT vs. sham, PRP vs. placebo and finasteride vs. minoxidil 2% was very low. Results of this NMA indicate the emergence of novel, non‐hormonal therapies as effective treatments for hair loss; however, the quality of evidence is generally low. High‐quality randomized controlled trials and head‐to‐head trials are required to support these findings and aid in the development of more standardized protocols, particularly for PRP. Regardless, this analysis may aid physicians in clinical decision‐making and highlight the variety of non‐surgical hair restoration options for patients. [ABSTRACT FROM AUTHOR]

Androgenetic alopecia (AGA) is the most common type of alopecia. Currently, only topical minoxidil and oral finasteride, for men, are approved for its treatment. We report a case of a patient with male pattern AGA treated with topical minoxidil and oral finasteride for 2 years, with partial improvement. At this point, we added mesotherapy to the previous treatment. The patient had 20 sessions of sterile mesotherapy blend, containing minoxidil, finasteride, biotin, and D‐panthenol. We did the injections every two weeks and made the response assessment with global clinical photographs at the 10th and the 20th sessions when we noted a significant visible improvement in hair density and thickness. Mesotherapy or intradermotherapy is defined as a technique that involves the use of multiple intradermal injections of a mixture of compounds in low doses, at many points, near/over the affected sites. In our case, the patient had an excellent response to intradermotherapy as an adjunctive treatment, with no side effects. Although we still need additional clinical trials to standardize the therapy and treatment guidelines, mesotherapy seems to be a therapeutic option in the treatment of AGA, especially if the procedure happens in a medical facility, with correct indication and adequate execution of this promising technique. [ABSTRACT FROM AUTHOR]

Summary: Objective: Case reports have suggested an increased risk of gynecomastia with HMG‐CoA reductase inhibitors (ie, statins). A recent meta‐analysis also found that statins decrease circulating testosterone levels in men. We investigated whether statin use was associated with an increased risk of gynecomastia. Design: Case‐control study. Patients: A cohort of patients from a random sample of 9 053 240 US subjects from the PharMetrics Plus™ health claims database from 2006 to 2016 was created. Measurements: New cases of gynecomastia requiring at least two ICD‐9 codes were identified from the cohort and matched to 10 controls by follow‐up time and age using density‐based sampling. Rate ratios (RRs) for users of statins were computed using conditional logistic regression adjusting for alcoholic cirrhosis, hyperthyroidism, testicular cancer, Klinefelter syndrome, obesity, hypogonadism, hyperprolactinemia and use of spironolactone, ketoconazole, H2 receptor antagonists (H2 blockers), risperidone, testosterone and androgen deprivation therapy. Results: Our cohort included 6147 cases of gynecomastia and 61 470 corresponding matched controls. The adjusted RR for current, recent and past statin use with respect to gynecomastia was 1.19 (1.04‐1.36), 1.38 (1.15‐1.65) and 1.20 (1.03‐1.40), respectively. Conclusions: Statin use is associated with an increased risk of developing gynecomastia. Clinicians should be cognizant of this effect and educate patients accordingly. [ABSTRACT FROM AUTHOR]

This investigation aimed to modify finasteride (1) to finasteride dithiocarbamate (2) for subsequent synthesis of the rhenium analogue (3) and [99mTc]tricarbonyl complexes (4), to assess its prostate cancer (PCa) targeting potential in a rat model. To validate the identity of (4), reference (3) has been synthesized by using fac‐[Net4]2[ReBr3(CO)3] precursor and characterized by 1H‐NMR, 13C‐NMR, ESI‐MS, and elemental analysis. The analogue (4) was synthesized by using fac‐[99mTc(H2O)3(CO)3]+ precursor, and its structure was confirmed by comparative HPLC by using (3) as a reference. Further, the suitability of (4) as a PCa imaging agent was investigated in vitro and in vivo. At room temperature, (4) had ≥99% radiochemical purity and remained ≥84% stable in serum. In preclinical studies, biodistribution of (4) in histopathologically established rat model showed adequately high in vivo uptake in the prostate attracting the possibility of using it for noninvasive imaging of PCa. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Urinary tract infection, urinary frequency, urgency, urodynia and haemorrhage are common post‐operative complications of thulium laser resection of the prostate (TmLRP). Our study mainly focuses on the role of finasteride in prostate wound healing through AR signalling. Materials and methods: TmLRP beagles were randomly distributed into different treatment groups. Serum and intra‐prostatic testosterone and DHT level were determined. Histological analysis was conducted to study the re‐epithelialization and inflammatory response of the prostatic urethra in each group. We investigated the role of androgen in proliferation and inflammatory response in prostate. In addition, the effects of TNF‐α on prostate epithelium and stromal cells were also investigated. Results: Testosterone and DHT level increased in testosterone group and DHT decreased in finasteride group. Accelerated wound healing of prostatic urethra was observed in the finasteride group. DHT suppressed proliferation of prostate epithelium and enhanced inflammatory response in prostate. We confirmed that DHT enhanced macrophages TNF‐α secretion through AR signalling. TNF‐α suppressed proliferation of prostate epithelial cells and retarded cell migration. TNF‐α also played a pivotal role in suppressing fibroblasts activation and contraction. Conclusion: Testosterone treatment repressed re‐epithelialization and wound healing of prostatic urethra. Finasteride treatment may be an effective way to promote prostate re‐epithelialization. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: A recent regulatory warning and case reports have described the development of muscle complications with the use of 5‐α reductase inhibitors (5ARIs). We wished to determine if there was a link between rhabdomyolysis and 5ARI usage. Methods: We used a matched cohort design and linked administrative data from the province of Ontario, Canada, to investigate the risk of rhabdomyolysis in men using either finasteride or dutasteride. A total of 99 covariates were measured. We identified 93 197 men ≥66 years of age who initiated a new prescription for a 5ARI, and they were matched using a propensity score to an equal number of men not prescribed a 5ARI. Results: New initiation of 5ARIs was not associated with a significantly increased risk of rhabdomyolysis (hazard ratio [HR] 1.21, 95% confidence interval [CI], 1.00‐1.48, P = .06). When we examined the risk of rhabdomyolysis in the year prior to the initiation of a 5ARI, we found that men who would go on to use a 5ARI in the future had an elevated risk of rhabdomyolysis even prior to starting the medication (HR 1.31, 95% CI, 1.05‐1.64, P = .01). Our secondary outcome of myositis and myopathy was significantly higher among 5ARI users (HR 1.63, 95% CI, 1.48‐1.80, P < .01), and this risk was not present prior to 5ARI usage. Conclusion: 5‐α reductase inhibitors do not appear to be associated with the development of rhabdomyolysis; however, they may be associated with an increased risk of myopathy and myositis. [ABSTRACT FROM AUTHOR]

Summary: Aims: Finasteride inhibits the conversion of testosterone to dihydrotestosterone. Because androgen regulates dopaminergic system in the brain, it could be hypothesized that finasteride may inhibit dopaminergic system. The present study therefore investigates the effects of finasteride in adolescent and early developmental rats on dopaminergic system, including contents of dopamine and its metabolites (dihydroxy phenyl acetic acid and homovanillic acid) and tyrosine hydroxylase expressions both at gene and protein levels. Meanwhile, open‐field behaviors of the rats are examined because of the regulatory effect of dopaminergic system on the behaviors. Methods: Open‐field behaviors were evaluated by exploratory and motor behaviors. Dopamine and its metabolites were assayed by liquid chromatography‐mass spectrometry. Tyrosine hydroxylase mRNA and protein expressions were determined by real‐time qRT‐PCR and western blot, respectively. Results: It was found that in adolescent male rats, administration of finasteride at doses of 25 and 50 mg/kg for 14 days dose dependently inhibited open‐field behaviors, reduced contents of dopamine and its metabolites in frontal cortex, hippocampus, caudate putamen, nucleus accumbens, and down‐regulated tyrosine hydroxylase mRNA and protein expressions in substantia nigra and ventral tegmental area. However, there was no significant change of these parameters in early developmental rats after finasteride treatment. Conclusion: These results suggest that finasteride inhibits dopaminergic system and open‐field behaviors in adolescent male rats by inhibiting the conversion of testosterone to dihydrotestosterone, and imply finasteride as a potential therapeutic option for neuropsychiatric disorders associated with hyperactivities of dopaminergic system and androgen. [ABSTRACT FROM AUTHOR]

A potential link has been suggested between dispensed finasteride and increased risk of male breast cancer (MBC). Due to the rare occurrence of MBC, it remains to be established if such a relationship exists. The purpose of this study was to combine nationwide registers in four countries to assess the potential association between dispensed finasteride and MBC. A cohort of all males with dispensed finasteride in Denmark, Finland, Norway, and Sweden (1,365,088 person years) was followed up for up to 15 years for breast cancer, and compared to a cohort of males unexposed to finasteride. Individual- level register data included country, dates of dispensed finasteride, MBC diagnosis, and death. Incidence rate ratios (IRRs) were estimated using a generalized linear model with a Poisson distribution. An increased risk of MBC was found among finasteride users (IRR = 1.44, 95% confidence interval [95% CI] = 1.11-1.88) compared to nonusers. The IRR increased to 1.60 (95% CI = 1.20-2.13) when users in Norway and Sweden with short follow- up time were excluded. The highest IRR was seen among men with medium duration of dispensed finasteride, medium accumulated consumption of finasteride, and among men with first dispensed finasteride prescription 1-3 years prior to diagnosis. The analyses suggested possible ascertainment bias and did not support a clear relationship between dispensed finasteride and MBC. In conclusion, a significant association between dispensed finasteride and MBC was identified. However, due to limited data for adjustment of potential confounding and surveillance bias in the present study, further research is needed to confirm these results. [ABSTRACT FROM AUTHOR]

Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTS) in older men. In this regard, recent studies have attempted to define the relationships between prostatic fibrosis, LUTS, and increased expression of transforming growth factor β1 (TGF β1) in BHP. Therapeutic approaches for BPH such as 5-α-reductase inhibitors and alpha-adrenergic blocking agents increase TGF β1 expression in the prostatic tissue. Here, we investigated the effects of the 5-α-reductase inhibitor-finasteride-on rat ventral prostate tissue, especially with regard to the tissue distribution and gene expression of fibrillar collagens. Adult Wistar rats (n = 15) were treated with finasteride (25 mg/kg/day) by subcutaneous injection for 7 and 30 days. Age-matched, vehicle-treated (n = 15) adult Wistar rats were used as control. Finasteride treatment reduced prostate size and increased the area of types I and III collagen fibers in the prostatic stroma. As expected, TGF β1 mRNA expression was upregulated by finasteride treatment. However, COL1A1 and COL3A1 mRNA expressions decreased after both 7 and 30 days of finasteride treatment, suggesting that finasteride treatment promotes prostate parenchyma and stroma changes, which lead to the observed types I and III collagen remodeling without de novo collagen synthesis. The upregulation of TGF β1 mRNA and protein associated with the 5-α-reductase inhibitor is more closely related to epithelial and stromal cell death pathways than to prostatic fibrosis. [ABSTRACT FROM AUTHOR]

Background Hidradenitis suppurativa ( HS) is rare in childhood, with only 2% of cases in patients younger than 11 years. It is a chronic, recurrent, debilitating condition for which no universally effective treatment has been developed. We present five cases of children with HS diagnosed between the ages of 6 and 11 years. Methods Patients were treated with oral finasteride 1 to 5 mg/day. All had entered puberty at the time of treatment initiation. All had normal laboratory results before starting treatment. The maximum duration of treatment was 24 months. Results Four patients were female. Two were overweight. Three had been previously treated with oral antibiotics, and two of these with oral isotretinoin, with partial or no improvement. Overall improvement of the disease was observed in all patients, with a reduction of the frequency and intensity of the flares. No adverse effects were observed or reported during treatment. Conclusion Treatment of HS can be challenging. The options available include antimicrobials, immunosuppressants, hormonal therapies, lasers, and surgery. The authors report the largest series of children with HS treated with finasteride. The results support the use of finasteride as monotherapy for the treatment of this disease in children. Further studies are necessary to fully understand the role of this drug in the management of this disease. [ABSTRACT FROM AUTHOR]

Despite their efficacy in the treatment of benign prostatic hyperplasia, the popularity of inhibitors of 5α-reductase (5 ARIs) is limited by their association with adverse sexual side effects. The aim of this study was to review and meta-analyze currently available randomized clinical trials evaluating the rate of sexual side effects in men treated with 5 ARIs. An extensive Medline Embase and Cochrane search was performed including the following words: 'finasteride', 'dutasteride', 'benign prostatic hyperplasia'. Only placebo-controlled randomized clinical trials evaluating the effect of 5 ARI in subjects with benign prostatic hyperplasia were considered. Of 383 retrieved articles, 17 were included in this study. Randomized clinical trials enrolled 24,463 in the active and 22,270 patients in the placebo arms, respectively, with a mean follow-up of 99 weeks and mean age of 64.0 years. No difference was observed between trials using finasteride or dutasteride as the active arm considering age, trial duration, prostate volume or International Prostatic Symptoms Score at enrollment. Overall, 5 ARIs determined an increased risk of hypoactive sexual desire [ OR = 1.54 (1.29; 1.82); p < 0.0001] and erectile dysfunction [ OR = 1.47 (1.29; 1.68); p < 0.0001]. No difference between finasteride and dutasteride regarding the risk of hypoactive sexual desire and erectile dysfunction was observed. Meta-regression analysis showed that the risk of hypoactive sexual desire and erectile dysfunction was higher in subjects with lower Qmax at enrollment and decreased as a function of trial follow-up. Conversely, no effect of age, low urinary tract symptom or prostate volume at enrollment as well as Qmax at end-point was observed. In conclusion, present data show that the use of 5 ARI significantly increases the risk of erectile dysfunction and hypoactive sexual desire in subjects with benign prostatic hyperplasia. Patients should be adequately informed before 5 ARIs are prescribed. [ABSTRACT FROM AUTHOR]

Background Postmarketing reports suggest that finasteride causes sexual dysfunction despite a low incidence reported in clinical trials. Therefore, the extent of risk remains unknown. Objective To determine whether the risk of sexual dysfunction is higher among individuals treated with finasteride compared to a baseline risk for all other drugs using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods A case by non-case disproportionality approach was used whereby a reporting odds ratio (ROR) with 95% confidence interval (CI) was calculated. The National Ambulatory Medical Care Survey (NAMCS) was used to confirm results. Results A significant disproportionality in reporting of sexual dysfunction with the use of finasteride was observed whether finasteride was indicated for hair loss (ROR = 138.17, 95% CI: 133.13, 143.4), prostatic hyperplasia (ROR = 93.88, 95% CI: 84.62, 104.16) or any indication (ROR = 173.18, 95% CI: 171.08, 175.31). When these results were stratified by age, disproportionality was strongest at 31-45 years. Conclusion Use of finasteride has led to an increase in reports of sexual dysfunction where it is believed to be the primary suspect. [ABSTRACT FROM AUTHOR]

The purpose of this study was to determine whether 5α-reductase inhibitors (5-ARIs) affect the discrimination between low-grade prostate cancer and benign tissues on multiparametric MRI (mpMRI). Twenty men with biopsy-proven Gleason 3 + 3 prostate cancer and 3 T mpMRI were studied. Ten patients (Tx) had been receiving 5-ARIs for at least a year at scan time. Ten untreated patients (Un) were matched to the treated cohort. For each subject two regions of interest representing cancerous and benign tissues were drawn within the peripheral zone of each prostate, MR measures evaluated, and cancer contrast versus benign (contrast = (MRTumor − MRHealthy)/MRHealthy) calculated. Decreased cancer contrast was noted on T2-weighted images: 0.4 (Un) versus 0.3 (Tx). However, for functional MR measures, a better separation of cancerous and benign tissues was observed in the treated group. Cancer contrast on high- b diffusion-weighted imaging (DWI) was 0.61 (Un) versus 0.99 (Tx). Logistic regression analysis yielded higher AUC (area under the curve) values for distinguishing cancerous from benign regions in treated subjects on high- b DWI (0.71 (Un), 0.94 (Tx)), maximal enhancement slope (0.95 (Un), 1 (Tx)), peak enhancement (0.84 (Un), 0.93 (Tx)), washout slope (0.78 (Un), 0.99 (Tx)), Ktrans (0.9 (Un), 1 (Tx)), and combined measures (0.86 (Un), 0.99 (Tx)). Coefficients of variation for MR measures were lower in benign and cancerous tissues in the treated group compared with the untreated group. This study's results suggest an increase in homogeneity of benign and malignant peripheral zone prostatic tissues with 5-ARI exposure, observed as reduced variability of MR measures after treatment. Cancer discrimination was lower with T2-weighted imaging, but was higher with functional MR measures in a 5-ARI-treated cohort compared with controls. [ABSTRACT FROM AUTHOR]

Androgen is an essential factor involved in masculinization of external genitalia. Failure of the exposure to 5α-dihydrotestosterone ( DHT) causes a hypoplastic penile size and urethral abnormality. The main pathology of hypospadias is defective urethral closure on the ventral side of the penis. Hormone-dependent genes are suggested as the causative factors. However, the detailed mechanisms of DHT functions on urethral tube formation remain unknown. Androgen is both a positive and negative regulator of cell proliferation. The roles of locally converted DHT in cell proliferation at the periurethral mesenchyme have not been elucidated. We revealed the expression pattern of 5α-reductase type 2 mRNA ( Srd5a2) and local DHT distribution by direct measurement in this study. We also analyzed periurethral mesenchymal cell proliferation status using systematic three-dimensional (3D) reconstruction analyses. A prominent Srd5a2 expression and localized DHT distribution on the ventral side of the genital tubercle were detected. Cell proliferation was reduced in this mesenchymal region during urethral formation. The current results suggest the presence of the possible negative regulation of cell proliferation by DHT. Moreover, cell proliferation related to urethral tube formation was revealed to be DHT dose dependent. These data are expected to contribute to the understanding of the mode of regulation of cell proliferation related to urethral tube formation by DHT. These findings may also offer insight into the understanding of human hypospadias and related hormone-dependent factors. [ABSTRACT FROM AUTHOR]