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Current FDA-approved treatments for androgenetic alopecia (AGA) are oral finasteride and topical minoxidil. Topical finasteride offers a potential alternative with similar efficacy and fewer systemic side effects. This study evaluated the effectiveness and safety of combining topical finasteride and minoxidil for male AGA. This 12-week randomized controlled trial divided subjects into two groups which are topical finasteride 0.1%-minoxidil 5% (treatment) and topical minoxidil 5% (control) (NCT05990400, registered 2023-08-04). Hair density, hair diameter, terminal hair rate, and vellus hair rate (assessed using phototrichogram), and the occurrence of side effects (SE) was monitored at four-week intervals. Out of 40 subjects, 2 dropped out in the treatment group. Significant increases in hair density, diameter, and terminal hair rate; and decrease of vellus hair rate were observed at each visit compared to baseline, yet no differences between groups. Systemic SEs included libido reduction (control), mild erectile dysfunction, and chest pain (treatment). Common local SEs (itching, shedding, and dandruff) were similar between groups. One patient (treatment) experienced contact dermatitis. Combining topical finasteride 0.1% with topical minoxidil 5% has similar safety and effectiveness for increasing hair density and diameter in male AGA patients compared to topical minoxidil 5% after 12 weeks of observation.

Androgenetic alopecia in males is associated with genetic predisposition and increased androgen secretion. This work was to investigate the clinical therapeutic effects of microneedling plus5% Minoxidil and Finasteride in treating male androgenetic alopecia. 45 male patients with androgenetic alopecia were recruited and rolled into control group 1 (Group A) received monotherapy with 5% Minoxidil; control group 2 (Group B) received 5% Minoxidil and Finasteride; and the experimental group (Group C) received combination therapy with microneedling, 5% Minoxidil, and Finasteride. Each group consisted of 15 patients. Comparison was made on trace element levels, testosterone levels, hair microscopy indicators, Norwood Hamilton hair loss (HL) classification, self-rating of hair growth and Ars (ARs). After treatment, the contents of trace elements and hormone levels in the three groups did not change considerably( P  > 0.05). After treatment, the ratio of villi to single hair follicle in the three groups decreased markedly. The decline degree of group B and group C was superior to group A ( P  < 0.05), while that of group C was superior to group B ( P  > 0.05). After treatment, the hair density and hair shaft diameter of the three groups of patients increased markedly. The increase of group B and group C was superior to group A ( P  < 0.05), while that of group C was superior to group B ( P  > 0.05). After treatment, the Norwood-Hamilton alopecia scale in group C was better than that in group A ( P  < 0.01). A total of 80% patients in group C scored ≥ 3, which was better than the other two groups in general. The incidence of ARs differed slightly among the three groups ( P  > 0.05). Relative to the use of Minoxidil or combination therapy with Finasteride alone, microneedling combined therapy greatly improved hair loss in patients, promoted new hair growth, and holds clinical value.

Abstract Context Glucocorticoids (GCs) are commonly prescribed, but their use is associated with adverse metabolic effects. 5α-reductase inhibitors (5α-RI) are also frequently prescribed, mainly to inhibit testosterone conversion to dihydrotestosterone. However, they also prevent the inactivation of GCs. Objective We hypothesized that 5α-RI may worsen the adverse effects of GCs. Design Prospective, randomized study. Patients A total of 19 healthy male volunteers (age 45 ± 2 years; body mass index 27.1 ± 0.7kg/m2). Interventions Participants underwent metabolic assessments; 2-step hyperinsulinemic, euglycemic clamp incorporating stable isotopes, adipose tissue microdialysis, and biopsy. Participants were then randomized to either prednisolone (10 mg daily) or prednisolone (10 mg daily) plus a 5α-RI (finasteride 5 mg daily or dutasteride 0.5 mg daily) for 7 days; metabolic assessments were then repeated. Main Outcome Measures Ra glucose, glucose utilization (M-value), glucose oxidation, and nonesterified fatty acids (NEFA) levels. Results Co-administration of prednisolone with a 5α-RI increased circulating prednisolone levels (482 ± 96 vs 761 ± 57 nmol/L, P = 0.029). Prednisolone alone did not alter Ra glucose (2.55 ± 0.34 vs 2.62 ± 0.19 mg/kg/minute, P = 0.86), M-value (3.2 ± 0.5 vs 2.7 ± 0.7 mg/kg/minute, P = 0.37), or glucose oxidation (0.042 ± 0.007 vs 0.040 ± 0.004 mmol/hr/kg/minute, P = 0.79). However, co-administration with a 5α-RI increased Ra glucose (2.67 ± 0.16 vs 3.05 ± 0.18 mg/kg/minute, P < 0.05) and decreased M-value (4.0 ± 0.5 vs 2.6 ± 0.4 mg/kg/minute, P < 0.05), and oxidation (0.043 ± 0.003 vs 0.036 ± 0.002 mmol/hr/kg, P < 0.01). Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1 ± 28.9 vs 36.8 ± 14.3 μmol/L, P = 0.81), unless co-administered with a 5α-RI (49.8 ± 8.6 vs 88.5 ± 13.5 μmol/L, P < 0.01). Conclusions We have demonstrated that 5α-RIs exacerbate the adverse effects of prednisolone. This study has significant translational implications, including the need to consider GC dose adjustments, but also the necessity for increased vigilance for the development of adverse effects.

Background Minoxidil and finasteride are currently the only FDA‐approved pharmacological treatments for androgenic alopecia (AGA) and female androgenic alopecia (FAGA). However, substantial improvement is observed in no more than 20% of patients in the medium term. To enhance clinical responses, nonpharmacological dietary supplementation is often utilized. Aims This study evaluated the efficacy of a novel dietary supplement, AGA‐P, which contains Serenoa repens extract, Cucurbita pepo extract, L‐Cystine, and Vitamin C, in a multicenter, randomized, assessor‐blinded, real‐life trial alongside pharmacological treatments. The objective was to determine whether dietary supplementation could improve the clinical efficacy of minoxidil and finasteride. Patients and Methods A total of 225 subjects with AGA or FAGA (165 men, mean age 40 ± 14 years, range 18–74) were enrolled after obtaining informed consent. Inclusion criteria included male subjects over 18 years and postmenopausal women with mild to moderate AGA/FAGA, eligible for dietary and/or pharmacological treatment. Of these participants, 106 (24 women and 82 men) were assigned to receive pharmacological treatment plus dietary supplementation (one capsule daily; Group A), while 119 (36 women and 83 men) received drug treatment only (Group B). The pharmacological treatments consisted of topical minoxidil and oral finasteride in most cases. Treatment duration was 6 months. Results The results indicated that oral supplementation significantly increased the clinical efficacy of pharmacological treatments for mild‐to‐severe AGA/FAGA compared to drug treatment alone (great improvement: Group A 36.5% vs. Group B 25%; p = 0.04). Conclusion Oral supplementation of AGA‐P significantly increases the clinical efficacy of pharmacological treatments for mild‐to‐severe AGA/FAGA (Study Registration: ISRCTN‐19671217).

BackgroundProstate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cancers. While AS reduces overtreatment (and quality of life impact), long-term compliance can be poor, with many men undergoing radical treatment after starting AS.Methods and analysisFinasteride in Active Surveillance for men with low and intermediate-risk prostate cancer (FINESSE) is a prospective, open-label, two-arm, phase 3 trial, in which men with low or intermediate PCa are randomised (1:1) to receive AS with or without finasteride (5 mg once a day for 2 years). Randomisation is stratified by age and PCa risk. AS includes regular prostate-specific antigen testing, MRI scans and the offer of repeat biopsy (at 3 years, or if imaging suggests progression). Additional MRI scans and/or biopsies will be performed for biochemical or clinical indications. We aim to recruit 550 men (aged 50 to 75 years) from up to eight sites. Active outpatient follow-up will be for 3–5 years (depending on date recruited), followed by passive registry-based follow-up for up to 10 years. Primary outcome is adherence to AS. Secondary outcomes include rates and type of disease progression, treatments received (for PCa and benign prostatic enlargement), overall and PCa-specific mortality, an understanding of patients/professionals views of this approach and health-related quality of life. An external panel of experts blinded to allocation will review all AS cessation and progression events. Trial pathologist’s and radiologist’s, blinded to allocation, will review representative cases. Analysis is Intention to Treat.Ethics and disseminationThe study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. Results will be made available to providers and researchers via publicly accessible scientific journals.Trial registration number ISRCTN16867955

Background Androgenetic alopecia (AGA) is the most prevalent type of hair loss. Traditionally, treatment for AGA has primarily involved the topical application of minoxidil in conjunction with oral finasteride or spironolactone. Recently, platelet‐rich plasma (PRP) has emerged as a significant focus of research in hair loss treatment. However, many studies on PRP‐assisted hair transplantation have encountered various limitations. Objective This study aims to conduct a prospective, comparative clinical investigation to evaluate the therapeutic effects of combining PRP with minoxidil and finasteride/spironolactone as adjuncts to hair transplantation. Method From August 2019 to December 2022, we enrolled 30 patients with AGA in the study, randomly assigning them to an experimental group and a control group. The experimental group received drug therapy alongside hair transplantation and underwent PRP injections, whereas the control group received only drug therapy to assist with hair transplantation. Results Prior to surgery, no significant differences in baseline data were observed between the two groups. Following treatment, the experimental group demonstrated significantly improved follicle survival rates, follicle growth rates, and hair strength compared with the control group. Conclusion This prospective, comparative clinical study demonstrated that the application of PRP in conjunction with pharmacological support during FUE treatment for AGA resulted in improved follicle survival rates, hair growth rates, and hair strength.

The effects on scalp and serum dihydrotestosterone (DHT) of different doses of a novel topical solution of 0.25% finasteride (P-3074), a type 2 5α-reductase, were investigated in men with androgenetic alopecia. Two randomized, parallel-group studies were conducted. Study I: 18 men received 1 mL (2.275 mg) P-3074, applied to the scalp once a day (o.d.) or twice a day (b.i.d), or 1 mg oral tablet o.d. for 1 week. Study II: 32 men received P-3074 at the dose of 100 (0.2275 mg), 200 (0.455 mg), 300 (0.6285 mg), or 400 (0.91 mg) μL or the vehicle o.d. for 1 week. Scalp and serum DHT and serum testosterone were evaluated at baseline and treatment end. Change from baseline in scalp DHT was -70% for P-3074 o.d. and approx. -50% for P-3074 b.i.d. and the tablet. Serum DHT decreased by 60 - 70%. The doses of 100 and 200 μL P-3074 resulted in a -47/-52% scalp DHT reduction, similar to the 300 and 400 μL doses (i.e., -37/-54%). A -5.6% inhibition was observed for the vehicle. Serum DHT was reduced by only -24/-26% with 100 and 200 μL P-3074 and by -44/-48% with 300 and 400 μL P-3074. No relevant changes occurred for serum testosterone. The novel finasteride 0.25% solution applied o.d. at the doses of 100 and 200 μL results in an appropriate inhibition of scalp DHT potentially minimizing the untoward sexual side-effects linked to a systemic DHT reduction.

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.

Benign prostatic hyperplasia (BPH) in older men can cause lower urinary tract symptoms (LUTS), which are increasingly managed with medications. Frailty may contribute to both symptom progression and serious adverse events (SAEs), shifting the balance of benefits and harms of drug therapy. To assess the association between a deficit accumulation frailty index and clinical BPH progression or SAE. This cohort study used data from the Medical Therapy of Prostatic Symptoms trial, which compared placebo, doxazosin, finasteride, and combination therapy in men with moderate-to-severe LUTS, reduced urinary flow rate, and no prior BPH interventions, hypotension, or elevated prostate-specific antigen. Enrollment was from 1995 to 1998, and follow-up was through 2001. Data were assessed in February 2021. A frailty index (score range, 0-1) using 68 potential deficits collected at baseline was used to categorized men as robust (score ≤0.1), prefrail (score 0.1 to <0.25), or frail (score ≥0.25). Primary outcomes were time to clinical BPH progression and time to SAE, as defined in the parent trial. Adjusted hazard ratios (AHRs) were estimated using Cox proportional hazards regressions adjusted for demographic variables, treatment group, measures of obstruction, and comorbidities. Among 3047 men (mean [SD] age, 62.6 [7.3] years; range, 50-89 years) in this analysis, 745 (24%) were robust, 1824 (60%) were prefrail, and 478 (16%) were frail at baseline. Compared with robust men, frail men were older (age ≥75 years, 12 men [2%] vs 62 men [13%]), less likely to be White (646 men [87%] vs 344 men [72%]), less likely to be married (599 men [80%] vs 342 men [72%]), and less likely to have 16 years or more of education (471 men [63%] vs 150 men [31%]). During mean (SD) follow-up of 4.0 (1.5) years, the incidence rate of clinical BPH progression was 2.2 events per 100 person-years among robust men, 2.9 events per 100 person-years among prefrail men (AHR, 1.36; 95% CI, 1.02-1.83), and 4.0 events per 100 person-years among frail men (AHR, 1.82; 95% CI, 1.24-2.67; linear P = .005). Larger point estimates were seen among men who received doxazosin or combination therapy, although the test for interaction between frailty index and treatment group did not reach statistical significance (P for interaction = .06). Risk of SAE was higher among prefrail and frail men (prefrail vs robust AHR, 1.81; 95% CI, 1.48-2.23; frail vs robust AHR, 2.86; 95% CI, 2.21-3.69; linear P < .001); this association was similar across treatment groups (P for interaction = .76). These findings suggest that frailty is independently associated with greater risk of both clinical BPH progression and SAEs. Older frail men with BPH considering initiation of drug therapy should be counseled regarding their higher risk of progression despite combination therapy and their likelihood of experiencing SAEs regardless of treatment choice.

Finasteride, a 5-alpha reductase inhibitor may have effects on biomarkers such as prostate-specific antigen (PSA) that could be leveraged to improve screening. To determine the predictive characteristics of biomarkers for prostate cancer for cancer on biopsy following 3 months of finasteride use compared with placebo. 383 men from multiple clinical sites with intermediate prostate cancer risk, without history of prostate cancer, were randomly allocated in a double-blinded manner, 4:1, to receive either finasteride or placebo for 90 days at which time a prostate biopsy was performed. The primary outcomes were associations of biomarkers with prostate cancer that were tested using multiple logistic regression and area under the receiver operating curves (AUC). Biomarkers for PCA risk (PCA3, TMPRSS2:ERG (T2:ERG) gene product, and PSA) were measured at baseline and at biopsy in a blinded fashion to assess the predictive performance of baseline levels, 90-day levels, and measures of change relative to standard predictors. A total of 292 (233 finasteride; 59 placebo) randomized patients underwent biopsy and were analyzed. On finasteride, baseline and 90-day measures of PCA3 and T2:ERG had similar moderate discrimination capacity with AUCs 62 to 65% (p-values < 0.001 and 0.001, respectively), but their rates of change had no discrimination ability (AUC 51%, (95% CI 43 to 60% p = 0.72) and 48% (95% CI 44 to 60%, p = 0.62), respectively).) Relative to baseline, the 90-day PCA3 and PSA decreased in the finasteride group by 25% and 50%, respectively (both p<0.001). T2:ERG had a smaller, non-significant change post finasteride treatment (p = 0.08). Short-term finasteride therapy did not improve performance of the most commonly-employed prostate cancer biomarkers. Threshold values for new biomarkers of prostate cancer should be interpreted with caution in patients receiving finasteride until formal validation of test performance in these patients is conducted. Three months of finasteride treatment did not increase the accuracy for predicting the outcome on prostate biopsy but did have a significant effect on biomarker values. Adjustments to thresholds for biopsy for men on finasteride are proposed. ClinicalTrials.gov, NCT01296672.