Efficacy, Safety, and Tolerability of a Wearable Electrotrichogenic Device in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Sham-Controlled Trial.

Androgenetic alopecia (AGA) is a common disorder in both males and females and may be improved by platelet-rich plasma (PRP) treatment. The aim of this study was to compare safety, efficacy, and satisfaction following treatment with a lower or higher number of platelets over 6 months. This was a prospective randomized, double-blinded, placebo, parallel-group, half-scalp IRB-approved study involving 8 subjects with moderate AGA. Participants received intradermal PRP injections (baseline and Month 3), according to 2 treatment protocols (high vs low platelet numbers) to the frontal and crown portions of the hemiscalp and normal saline to control sites. Phototrichoscans were recorded at baseline and at 6 months, and global photography and subject and investigator satisfaction questionnaires were obtained at baseline, 3, and 6 months. At the end of 6-month evaluation period, both groups demonstrated absolute increases in total hair density, follicle diameter, and terminal hair density, as well as absolute and percentage changes at the frontal and crown targeted sites compared with baseline. These improvements tended to occur more often in areas treated with higher platelet numbers than with lower numbers. Vellus hair densities did not exhibit any significant changes with either PRP dosages. The investigator and 6 of the subjects were "satisfied" with the results at 3 months and no adverse reactions were associated with the treatments. Intradermal injections with 2 therapeutic quantities of platelets were equally safe and efficacious for treating men and women with AGA. Higher numbers of platelets may have a greater effect than lower numbers of platelets in regard to hair density, follicle diameter, and terminal hair density but exhibited minimal effects on vellus hair densities at the 6-month evaluation point. Further studies are required to determine whether any significant advantages occur when delivering either lower or higher numbers of platelets in AGA treatments as long as therapeutic levels are administered.

Background: Recently, low-dose oral minoxidil (LDOM) has entered the landscape of therapies for androgenetic alopecia (AGA). We determined whether using LDOM is associated with improving AGA in a dose-dependent manner; secondarily, we examined whether a dose-dependent association also exists for safety. Methods: Systematic searches were conducted in PubMed and Scopus to identify studies that would be eligible for our quantitative analyses; the logistics of our analyses was determined by the data we gathered. Results: Six studies were eligible for quantitative analyses; we conducted meta-regressions. We found that, for persons with AGA, increasing the dosage of LDOM by 1 mg/day was – after six months – significantly associated with an expected sex-adjusted increase in hair diameter (mean difference = 1.4 μm, p = 0.01), total hair density (mean difference = 47.1 hairs/cm², p = 0.007), terminal hair density (mean difference = 9.1 hairs/cm², p = 0.001), risk of hypertrichosis (mean difference = 17.9%, p = 0.006), and cardiovascular adverse events (mean difference = 4.8%, p = 0.004). Conclusions: Our study produced new evidence as our work is the first to show a positive dose-dependent association between the use of LDOM and change in hair diameter, hair density, risk of hypertrichosis, and cardiovascular adverse events for persons with AGA. Future randomized trials could produce causal evidence that would corroborate these dose-dependent associations.

The evidence base pertaining to the efficacy of monotherapies for androgenetic alopecia (AGA), the most common form of hair loss, is ever expanding-and this warrants a formal comparison therapies' effect on a frequent basis. The objective of the current study was to determine the comparative effect of relevant monotherapies for male AGA. Our aim was achieved by conducting Bayesian network meta-analysis (NMA), under a random effects model, for two outcomes: 6-month change in (1) total and (2) terminal hair density in adult (i.e., aged 18 years and above) men with AGA; these analyses were preceded by a systematic search of the peer-reviewed literature for suitable data. Interventions' surface under the cumulative ranking curve (SUCRA) and pairwise relative effects (quantified as mean differences) were estimated through the NMAs. We determined the comparative effect of 20 active comparators and a control (i.e., placebo/vehicle). "Dutasteride 0.5 mg once daily for 24 weeks" was ranked the most effective in terms of 6-month change in (1) total hair density (SUCRA = 87%) and terminal hair density (SUCRA = 98%). Our results showed that interventions' effectiveness can be dose dependent. Our updated analyses of the up-to-date evidence regarding monotherapies for male AGA showed that the oral form of 5-alpha reductase inhibitors are more effective than oral minoxidil and other newer agents like Botox, microneedling, and photobiomodulation. Our findings can better inform clinical decision making and design of future research studies.

Androgenetic alopecia (AGA) is a hair disorder seen in both sexes. Its aetiology is multifactorial. Treating AGA has always been a challenge for dermatologists. Only a few drugs such as topical minoxidil and finasteride are U.S. Food and Drug Administration-approved for treating AGA. Thus, looking for new and more effective treatment options for AGA is imperative. This review was conducted to compare the efficacy of oral with topical minoxidil in treating AGA. Only clinical trials that compared oral with topical minoxidil in treating AGA were included in this review. PubMed, Cochrane, Scopus and ClinicalTrials.gov were searched. A total of 2063 studies were retrieved from the databases. Four studies met the inclusion criteria and were included in this systematic review. Outcomes such as hair density, terminal hair density, hair count, global photographic assessment and negative hair pull were studied in this review. The results showed that there was no significant difference between oral and topical minoxidil in terms of improving the hair density of patients with AGA (overall mean difference 0.95, 95% confidence interval -24.98 to 26.87). Two studies showed that the mean difference in terminal hair density was greater in patients treated with oral minoxidil, but there was no significant difference between the two treatments in terms of improving terminal hair density. The efficacy of oral minoxidil is comparable to that of topical minoxidil in terms of improving hair density and terminal hair density in patients with AGA. Oral minoxidil can be used as an adjunct or as a second-line treatment option for AGA.

There has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials. To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA. This double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023. Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks. The primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation. Among 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm2 (95% CI, -18.2 to 21.5; P = .27) for terminal hair density and 2.6 hairs per cm2 (95% CI, -10.3 to 15.8; P = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, -0.3 to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, -12.5 to 23.5; P = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but not on the frontal scalp (12%; 95% CI, -12 to 36; P = .24). The most common adverse effects in the oral minoxidil group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]). In this study, oral minoxidil, 5 mg, once per day for 24 weeks did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA. Brazilian Registry of Clinical Trials Identifier: RBR-252w9r.

Characterized by progressive hair loss due to an excessive response to androgens, androgenetic alopecia (AGA) affects up to 50% of males and females. Minoxidil is one of approved medications for AGA but inadequate responses occur in many patients. To determine whether 1565 nm non-ablative fractional laser (NAFL) could yield better therapeutic benefits for patients with AGA as compared with 5% minoxidil. Thirty patients with AGA were enrolled; they were randomly assigned into the laser or minoxidil treatment groups. For the laser treatment group, patients were treated by 1565 nm NAFL at 10 mJ, 250 spots/cm2 with 2 weeks intervals for 4 sessions in total. For the minoxidil treatment group, 1-milliliter of topical 5% minoxidil solution was applied to hair loss area twice a day. The primary outcomes were the changes in numerous hair growth indexes at the Week 10 as compared with the baselines. Both 1565 nm NAFL and 5% minoxidil led to significantly greater hair densities and diameters in patients at the Week 10 than the baselines (p < 0.01). As compared with 5% minoxidil, 1565 nm NAFL showed significantly greater improvements in total hair number, total hair density (hair/cm2), terminal hair number, terminal hair density (hair/cm2), number of hair follicle units, and average hair number/number of hair follicle units. Our data demonstrate that 1565 nm NAFL exhibits superior clinical efficacy in some aspects of hair growth to the topical minoxidil. It is a safe and effective modality in treating AGA.

Male pattern baldness, or androgenetic alopecia, affects approximately 50% of the adult population and can cause poor self-image, low self-esteem and have a significant negative impact on the quality of life. An oral nutraceutical supplement based on a marine complex formulation has previously been reported to significantly increase the number of terminal hairs in women with thinning hair. The objective of this double-blind, placebo-controlled study was to confirm the beneficial effects of a similar marine complex supplement in adult male subjects with thinning hair (Viviscal® Man; Lifes2good, Inc., Chicago, IL, USA). Healthy adult male subjects with thinning hair associated with clinically diagnosed male pattern hair loss were enrolled and randomized to receive study drug or placebo twice daily. At Day 90, subjects indicated a significant improvement in three of six quality of life measures as well as a significant overall improvement in quality of life. After 180 days, significant increases were observed for total hair count, total hair density, and terminal hair density (for each, P = 0.001). The investigator assessments revealed significant improvements in terminal and vellus hair count and terminal hair density. Hair pull test results were significantly lower (fewer hairs removed) for study drug vs. placebo at Days 90 (P < 0.05) and 180 (P < 0.01). There were no reports of treatment-emergent adverse events. The results of this study showed for the first time that a dietary supplement containing a marine complex and other ingredients can decrease hair shedding and promote hair growth in men with thinning hair.

SignificanceMale and female pattern hair loss are common, chronic dermatologic disorders with limited therapeutic options. In recent years, a number of commercial devices using low-level laser therapy have been promoted, but there have been little peer-reviewed data on their efficacy.ObjectiveTo determine whether treatment with a low-level laser device, the US FDA-cleared HairMax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss.MethodsRandomized, sham device-controlled, double-blind clinical trials were conducted at multiple institutional and private practices. A total of 146 male and 188 female subjects with pattern hair loss were screened. A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham device in concealed sealed packets, and were treated on the whole scalp three times a week for 26 weeks. Terminal hair density of the target area was evaluated at baseline and at 16- and 26-week follow-ups, and analyzed to determine whether the hypothesis formulated prior to data collection, that lasercomb treatment would increase terminal hair density, was correct. The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study. The evaluator of masked digital photographs was blinded to which trial arm the subject belonged.ResultsSeventy-eight, 63, 49, and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects, 12-beam lasercomb treatment in female subjects, 7-beam lasercomb treatment in male subjects, and 9- and 12-beam lasercomb treatment in male subjects, compared with the sham device, respectively. Nineteen female and 25 male subjects were lost to follow-up. Among the remaining 122 female and 103 male subjects in the efficacy analysis, the mean terminal hair count at 26 weeks increased from baseline by 20.2, 20.6, 18.4, 20.9, and 25.7 per cm2 in 9-beam lasercomb-treated female subjects, 12-beam lasercomb-treated female subjects, 7-beam lasercomb-treated male subjects, and 9- and 12-beam lasercomb-treated male subjects, respectively, compared with 2.8 (p < 0.0001), 3.0 (p < 0.0001), 1.6 (p = 0.0017), 9.4 (p = 0.0249), and 9.4 (p = 0.0028) in sham-treated subjects (95 % confidence interval). The increase in terminal hair density was independent of the age and sex of the subject and the lasercomb model. Additionally, a higher percentage of lasercomb-treated subjects reported overall improvement of hair loss condition and thickness and fullness of hair in self-assessment, compared with sham-treated subjects. No serious adverse events were reported in any subject receiving the lasercomb in any of the four trials.Conclusions and relevanceWe observed a statistically significant difference in the increase in terminal hair density between lasercomb- and sham-treated subjects. No serious adverse events were reported. Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in both men and women. Additional studies should be considered to determine the long-term effects of low-level laser treatment on hair growth and maintenance, and to optimize laser modality.

Background: Androgenetic alopecia (AGA) is a common form of scalp hair loss that affects up to 50% of males between 18 and 40 years old. Several molecules are commonly used for the treatment of AGA, acting on different steps of its pathogenesis (Minoxidil, Finasteride, Serenoa repens) and show some side effects. In literature, on the basis of hypertrichosis observed in patients treated with analogues of prostaglandin PGF2a, it was supposed that prostaglandins would have an important role in the hair growth: PGE and PGF2a play a positive role, while PGD2 a negative one.Objective: We carried out a pilot study to evaluate the efficacy of topical cetirizine versus placebo in patients with AGA. Patients and methods: A sample of 85 patients was recruited, of which 67 were used to assess the effectiveness of the treatment with topical cetirizine, while 18 were control patients.Results: We found that the main effect of cetirizine was an increase in total hair density, terminal hair density and diameter variation from T0 to T1, while the vellus hair density shows an evident decrease. The use of a molecule as cetirizine, with no notable side effects, makes possible a good compliance by patients.Conclusion: Our results have shown that topical cetirizine 1% is responsible for a significant improvement of the initial framework of AGA.

Prostaglandins play a pivotal role in modulating hair growth cycle. Prostaglandin F2α and prostaglandin E have stimulating and prostaglandin D has inhibitory effects on hair follicle. Cetirizine inhibits release of prostaglandin D2 and stimulates the release of prostaglandin E2. In the present study, the efficacy and safety of twice daily application of topical cetirizine 1% versus minoxidil 5% solutions for 16 weeks were compared in male androgenetic alopecia (AGA). Forty men, aged 18 to 49 years, ‎were randomly divided into two equal groups to apply either cetirizine 1% or minoxidil 5% solutions. The study was divided into two phases, a 16-week treatment phase either with cetirizine or minoxidil (anagen phase), followed by an 8-week ‎ drug-free (telogen phase) with a follow-up when patients used placebo. Efficacy outcomes included the change in total hair density, vellus and terminal hair density, hair diameter and the percentage of hair in anagen and telogen phases from baseline in 16 and 24 weeks. After 16 weeks, we observed a significant increase in total and vellus hair density in both minoxidil and cetirizine groups, but the improvement was much higher in the minoxidil group. The percentage of hair in the anagen phase also increased in both groups after 16 weeks of treatment, but then diminished after 8 weeks of placebo consumption. No significant adverse reactions associated with the administration of cetirizine solution were reported. Cetirizine 1% solution was effective in hair growth without any complications for treatment of male AGA.

Background: Androgenetic alopecia (AGA) is the most common cause of hair loss. Currently, approved medications for AGA are topical minoxidil and oral finasteride, both of which are prescription medications which may cause side effects. Non-prescription products such as herbal extracts and over-the-counter medications have limited evidence regarding safety and efficacy; however, they may be an alternative for patients unable or unwilling to use prescription medication. Summary: This article reviews investigator-blinded, controlled clinical trials assessing the efficacy of non-prescription monotherapies in treating AGA. A total of 13 studies were included using procyanidin, cetirizine, caffeine, Oryza sativa bran, pumpkin seed oil, rosemary oil, saw palmetto, and watercress. The available data demonstrate considerable improvements in one or more parameters: total hair density, terminal hair density and hair diameter. Procyanidin and cetirizine were investigated in more investigator-blinded, randomized controlled trials than other agents. Minimal adverse events were observed; however, more robust clinical trial and long-term safety and efficacy data are warranted. Key Message: Additional investigations through the conduct of high quality randomized, controlled trials with larger numbers of patients will help determine the effectiveness and safety of this class of compounds, either as monotherapy or as an addition to current pharmacological interventions.

ABSTRACTBackground:Androgenetic alopecia (AGA) is the most common cause of hair loss in males which remains a therapeutic challenge.Objectives:To compare the efficacy of topical 5% minoxidil and 0.25% finasteride combination (MNF) over 5% minoxidil (MNX) or 0.25% finasteride (FNS) alone by assessing hair count, physician assessment score (PAS), and patient satisfaction score (PSS).Materials and Methods:Pilot randomized open-label study where 60 male patients with AGA ≥ III grade were randomized into three treatment groups and evaluated over 24 weeks. Improvement in hair count was assessed manually using dermoscopy. Global photographs were used to assess PAS. Side effects were evaluated using relevant laboratory investigations.Results:At the 12th and 24th week, all three groups showed significant improvement in total hair density as compared to baseline (P < 0.001). None of the groups was superior to the other (P > 0.05) at the 12th week but at 24th week, MNF was comparatively superior (P < 0.02). At the 12th week and 24th week, all three groups showed significant improvement in terminal hair density as compared to baseline (P < 0.001). In the 12th week, MNF was comparatively superior (P = 0.028) and at the 24th week, MNF was comparatively superior (P < 0.02). PAS and PSS were significantly better with MNF and MNX compared to FNS (P < 0.004). Side effects such as scaling and itching were reported with MNF and MNX.Conclusion:Topical minoxidil 5% and finasteride 0.25% had an overall better efficacy compared to monotherapy without significant side effects.

BackgroundIn recent years, androgenetic alopecia (AGA) has emerged as a significant public health concern due to its high prevalence and progressive nature. In addition to progressive scalp thinning and hair loss, patients often experience psychological distress and diminished quality of life. While standard treatments such as finasteride and minoxidil are effective, their side effects and adherence issues limit long-term use, making the exploration of safe and accessible intervention strategies essential. Dietary supplements, claimed to promote hair growth by inhibiting androgen pathways and improving the follicular microenvironment, have become an attractive adjunct for both clinicians and patients due to their low cost and ease of use. However, existing studies have limitations, including the diversity of supplements, small sample sizes, and the lack of direct comparisons among different supplements, making it unclear how they compare in terms of efficacy and safety. This study aims to use a network meta-analysis (NMA) to compare the effectiveness and safety of various dietary supplements based on outcomes such as hair density and terminal hair density, providing evidence-based support for clinical decision-making.MethodsA systematic search was conducted in English-language databases such as PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the use of dietary supplements for treating AGA. Stata 16.0 software was used for network meta-analysis, and Revman 5.4 software was utilized for evaluating study quality and bias risk; additionally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was applied to rate the certainty (quality) of evidence for the included studies.ResultsA total of 19 RCTs involving 1,658 AGA patients were included, with 894 patients in the supplement group and 764 in the control group. Sixteen dietary supplements were investigated. Results showed that compared with placebo, standardized plant extracts (Nutrafol), apple extract (AMSbzs, AMS), tocotrienols, pumpkin seed oil (PSO), and a compound extract of Cistanche and Laminaria (MK-R7) significantly improved hair density. Multi-component supplements (ALRV5XR), standardized plant extracts (Nutrafol), and probiotics effectively increased terminal hair density. In blind doctor assessments, PSO, capsaicin-isoflavones (CI), saw palmetto extract (ESR), Omega 3&6, Lambdapil, Nutrafol, and Multi-component supplements (AGA-P) showed higher hair regeneration scores than placebo or conventional treatments. No significant differences were found between interventions in terms of the terminal-to-vellus hair ratio. Overall, all dietary supplements were found to be well-tolerated.ConclusionDietary supplements have a positive impact on hair density, terminal hair density, and blind doctor evaluations in patients with androgenetic alopecia, with good tolerability. They may serve as beneficial adjuncts or alternatives to conventional treatments. Future large-scale, high-quality RCTs are needed to verify these findings.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251130173, Identifier CRD420251130173.

Background: A contributing factor to male pattern hair loss (MPHL) is a compromised microcirculation and increased vasoconstriction in the scalp. Since endothelial nitric oxide (NO) was found to act as a vasodilator, our study looked at the efficacy of an amaranthus hair cream in delivering absorbable nitrates to the scalp that would convert to NO resulting in vasodilation and also deliver the nutrients to the scalp. Methods: This was a randomized, double-blinded, placebo-controlled parallel arm study of 50 males of 25-45 years. The study included clinically diagnosed MPHL having Norwood classification III vertex, IV, V, and hair density >100 as measured with Trichoscan. Individuals having a history of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or dermatological conditions other than androgenic alopecia were excluded from the study. Amaranthus or placebo cream ∼2 g was applied to the targeted area once daily at night for 90 days. The primary outcome was the mean change in terminal hair density and hair-shaft diameter of terminal hair. The secondary outcome was a mean change in the density of vellus, anagen, and telogen hairs, pilary index, terminal to vellus ratio, and anagen to telogen ratio. Results: The terminal hair density increased significantly (p < 0.0001) by 28% from baseline while placebo had 15% change. Anagen hair count and density increased significantly (p < 0.0001) by 54% from baseline while placebo had a 17.5% change. The pilary index was significantly increased (p < 0.0001) by 25% from baseline while placebo had 7.3% change. The anagen by telogen ratio showed significant increase (p < 0.0001) of 1.5 times whereas placebo showed only 21% change. Conclusion: Amaranthus extract cream significantly improved anagen hair density and follicular health. No adverse effects recorded from this suggest that the Amaranthus extract cream is potential as a safe, and effective supportive therapy for MPHL.

IntroductionAndrogenetic alopecia (AGA) is the most common type of progressive hair loss, and current treatments are limited. Wound healing has been associated with hair regrowth; consequently, its mechanism has been suggested for treatment of hair loss. Nonablative radiofrequency (RF), which induces wound healing mechanisms through thermal damage, has been shown to increase hair growth when applied to the scalp. In this study, we aim to evaluate a specially adapted non‐ablative RF device as a noninvasive, nonsystemic treatment for AGA.MethodsAn open‐label study was conducted to evaluate the efficacy of a nonablative RF device for treatment of AGA. Patients diagnosed with Hamilton–Norwood Stage 3 or above were recruited and received 10 weekly RF treatment sessions. Hair counts were performed before and after treatment manually by a medical resident.ResultsTen male and 10 female subjects were recruited. Hair count, hair density (per cm2), vellus hair density (per cm2), terminal hair density (per cm2), cumulative thickness (mm/cm2), number of follicular units, density of follicular units (per cm2), and average hair per unit increased from before to after treatment. Only the increases in hair count, overall hair density, terminal hair density, cumulative thickness, and average hair count/unit were statistically significant (p &lt; .05).DiscussionWe observed significant improvement in hair growth in 19 out of 20 patients. Overall, significant improvement was observed in total hair counts, terminal hair counts, hair shaft thickness, and in the number of follicular units. Further clinical research is warranted to further explore nonablative RF for treatment of AGA.