Combination therapy with topical minoxidil and nano-microneedle-assisted fibroblast growth factor for male androgenetic alopecia: a randomized controlled trial in Chinese patients.
Ontology highlight
ABSTRACT:
SUBMITTER: Yu CQ
PROVIDER: S-EPMC8104149 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
Publications
Combination therapy with topical minoxidil and nano-microneedle-assisted fibroblast growth factor for male androgenetic alopecia: a randomized controlled trial in Chinese patients.
Yu Cheng-Qian CQ Zhang Hui H Guo Meng-Er ME Li Xiao-Kun XK Chen Hong-Duo HD Li Yuan-Hong YH Xu Xue-Gang XG
Chinese medical journal 20201105 7
Similar Datasets
Project description:Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders with a higher psychological impact on females. Currently, topical minoxidil is the only FDA-approved treatment for female AGA and it needs life-long application and causes side effects. Cetirizine is an antihistamine that may be effective in hair loss treatment. This study aimed to compare the efficacy and safety of topical cetirizine with minoxidil (group 1) versus topical minoxidil with placebo (group 2) in female patients with AGA. This was a double-blind, randomized, controlled, parallel study conducted at Dermatology Clinic, Cairo University Teaching Hospital (Kasr- Al- Ainy), Egypt. Sixty-six patients with female AGA, aged 20-50 years, Sinclair (II-IV), were randomly assigned to one of the 2 groups for 24 weeks. The trichoscopic parameters, patients' self-assessment, side effects and global photographic assessment were evaluated. There was a statistically significant change from baseline in frontal and vertex terminal and vellus hair density (P < 0.0005) with a significant increase in vertex hair shaft thickness and average number of hairs per follicular unit in group 1 (P < 0.05). Patients reported significantly better scores in patient self-assessment in group 1 (P < 0.05). Side effects were not significantly different between groups (P > 0.05). Topical cetirizine increases hair shaft thickness and results in a higher clinical improvement from patients' perspective with a good safety profile (NCT04481412, study start date: July 2020).
| S-EPMC10205881 | biostudies-literature
Project description:IntroductionTreatments for AGA have yet to produce satisfactory outcomes and may cause intolerable side effects. Recent studies have reported that adipose tissue-derived stem cell conditioned media (ADSC-CM) could induce hair growth and regeneration.ObjectiveTo investigate the efficacy of ADSC-CM combined with minoxidil for hair regeneration therapy in male AGA.MethodsThis study lasted for 6 weeks. Subjects were divided into two groups: concentrated and non-concentrated ADSC-CM. Scalp was divided vertically in half before intradermal injection was administered from the frontal region of the scalp toward the vertex with a 30G needle, spaced about 1 cm apart. Treatment side received 2 ml of ADSC-CM; the other side was given 2 ml of NaCl 0.9% as placebo. Patients applied 5% minoxidil twice daily post-injection. Improvements were assessed using photographs and trichoscan every 2 weeks.ResultsHair count, hair density, and mean thickness increased significantly on both sides after 6 weeks, while vellus rate decreased proportionally with the increase of terminal rate. No statistically significant differences between treatment groups were found. Minimum side effects were reported, and subjects were satisfied with the results.ConclusionCombination of ADSC-CM and minoxidil could be a potential agent for hair regrowth. Follow-up research with extensive populations, longer duration, and different study design may be required to confirm the exact mechanisms of ADSC-CM on hair growth.Trial registrationClinicaltrials.gov, NCT05296863. Registered 25 March 2022-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05296863 .
| S-EPMC10441691 | biostudies-literature
Project description:This study evaluates the efficacy and safety of the combined microneedling (CMNT) with minoxidil versus minoxidil monotherapy for the treatment of androgenetic alopecia (AGA), with a focus on the impact of microneedling parameters on treatment outcomes. We conducted a systematic review and meta-analysis (PROSPERO: CRD42024594487) of randomized controlled trials (RCTs) comparing CMNT versus minoxidil alone for AGA, following PRISMA guidelines. A comprehensive search across six databases was performed up to September 8, 2024. We identified 12 RCTs involving 631 AGA patients, with a total of 11 RCTs included in the meta-analyses. CMNT significantly improved hair count compared to minoxidil monotherapy (SMD 1.32, 95% CI 0.73-1.92, p < 0.01), with substantial heterogeneity (I² = 88%, p < 0.01). Subgroup analyses indicated no significant effect of microneedling (MN) depth (≤ 1 mm vs. >1 mm), duration (≤ 12 weeks vs. >12 weeks), or technique(device) (electrodynamic vs. rolling) on hair count outcomes. Additionally, A meta-analysis of six RCTs demonstrated a significant improvement in hair diameter with CMNT (SMD 0.34, 95% CI 0.11-0.58; p < 0.01), with no observed heterogeneity (I² = 0%). Investigators and patient's self-assessment scores were also improved. Adverse events were more frequent with CMNT (74 vs. 59 events), however they were generally considered mild or self-limiting. CMNT significantly enhances hair count and diameter in AGA patients with mild adverse events. MN parameters including depth, duration, and technique variations did not significantly affect hair count outcome, suggesting microneedling as a promising adjunctive AGA treatment.
| S-EPMC11890238 | biostudies-literature
Project description:BackgroundThere are regional variations in the scalp hair miniaturization seen in androgenetic alopecia (AGA). Use of topical minoxidil can lead to reversal of miniaturization in the vertex scalp. However, its effects on other scalp regions have been less well studied.ObjectivesTo determine whether scalp biopsies from men with AGA show variable gene expression before and after 8 weeks of treatment with minoxidil topical foam 5% (MTF) vs. placebo.MethodsA placebo-controlled double-blinded prospective pilot study of MTF vs. placebo was conducted in 16 healthy men aged 18-49 years with Hamilton-Norwood type IV-V thinning. The subjects were asked to apply the treatment (active drug or placebo) to the scalp twice daily for 8 weeks. Stereotactic scalp photographs were taken at the baseline and final visits, to monitor global hair growth. Scalp biopsies were taken at the leading edge of hair loss from the frontal and vertex scalp before and after treatment with MTF and placebo, and microarray analysis was performed using the Affymetrix GeneChip HG U133 Plus 2.0.ResultsGlobal stereotactic photographs showed that MTF induced hair growth in both the frontal and vertex scalp of patients with AGA. Regional differences in gene expression profiles were observed before treatment. However, MTF treatment induced the expression of hair keratin-associated genes and decreased the expression of epidermal differentiation complex and inflammatory genes in both scalp regions.ConclusionsThese data suggest that MTF is effective in the treatment of both the frontal and vertex scalp of patients with AGA.
| S-EPMC4362890 | biostudies-literature
Project description:ObjectiveIt still needs to be determined if platelet-rich plasma (PRP) has any added advantage over Minoxidil in treating androgenetic alopecia. We reviewed randomized controlled trials (RCTs) comparing scalp injections of PRP plus Minoxidil vs Minoxidil alone for managing androgenetic alopecia.MethodsAll RCTs published on Embase, Cochrane Library, and PubMed comparing PRP plus Minoxidil vs. Minoxidil alone were eligible. The literature search was completed on 5 March 2024. The review was registered on PROSPERO (CRD42024509826).ResultsOf five included RCTs, three had a high risk of bias, while one had some concerns. A systematic review of the studies showed that all trials reported better outcomes with PRP plus Minoxidil than with Minoxidil alone. Meta-analysis showed that hair density at one month (MD: 11.07 95% CI: 1.20, 20.94 I2 = 0%), three months (MD: 21.81 95% CI: 10.64, 33.00 I2 = 57%) and 5/6 months (MD: 17.80 95% CI: 7.91, 27.69 I2 = 80%) of follow-up was significantly better in the PRP plus Minoxidil vs the Minoxidil alone group. Meta-analysis of adverse events showed that the risk of adverse events was comparable in both groups (OR: 0.55 95% CI: 0.22, 1.36 I2 = 0%). The certainty of evidence on the GRADE assessment was "low to very low."ConclusionVery low-quality evidence shows that the addition of injectable PRP to topical Minoxidil may improve outcomes in patients with androgenetic alopecia. The addition of PRP was found to improve hair density and patient satisfaction significantly. However, the small number of studies with a high risk of bias and heterogeneity in PRP preparation methods are significant limitations of current evidence. Further studies with larger sample sizes and uniform PRP preparation protocols are needed.
| S-EPMC11356437 | biostudies-literature
Project description:ImportanceThere are knowledge gaps regarding the relative efficacy of 3 commonly used drugs for androgenetic alopecia (AGA), namely, minoxidil and the two 5-α reductase inhibitors dutasteride and finasteride.ObjectiveTo examine the relative efficacy of any dose and administration route of minoxidil, dutasteride, and finasteride for the treatment of male AGA.Data sourcesSystematic searches were performed in PubMed on March 5, 2021, without date restrictions.Study selectionEligible studies included those that investigated monotherapy with any dose and administration route of minoxidil, dutasteride, and finasteride.Data extraction and synthesisData on the mean (SD) difference and sample size were used for the bayesian network meta-analyses. League tables and surface under the cumulative ranking curve values were used to examine the relative efficacy of the interventions.Main outcomes and measuresStudy end points were change in total and terminal hair count after 24 and 48 weeks of therapy. The 4 end points were quantified in hairs per square centimeters.ResultsThe PubMed search yielded 848 records; after the 2 stages of screening, 23 studies were eligible for quantitative analyses. Mean (SD) age of patients ranged from 22.8 (3.3) years to 41.8 (12.3) years. The greatest increase in total hair count at 24 weeks (ie, first end point) was with 0.5 mg/d of dutasteride, which was significantly more efficacious than 1 mg/d of finasteride (mean difference, 7.1 hairs/cm2; 95% CI, 5.1-9.3 hairs/cm2) and minoxidil (0.25 mg/d [mean difference, 23.7 hairs/cm2; 95% CI, 9.5-38.0 hairs/cm2], 5 mg/d [mean difference, 15.0 hairs/cm2; 95% CI, 3.9-26.1 hairs/cm2], and 2% solution [mean difference, 8.5 hairs/cm2; 95% CI, 4.8-12.3 hairs/cm2]). The greatest increase in terminal hair count at 24 weeks (ie, second end point) was with 5 mg/d of minoxidil, which was significantly more efficacious than the 0.25-mg/d dose (mean difference, 43.6 hairs/cm2; 95% CI, 29.7-57.7 hairs/cm2) and its topical forms (in 2% [mean difference, 29.3 hairs/cm2; 95% CI, 21.1-37.5 hairs/cm2] and 5% [mean difference, 29.8 hairs/cm2; 95% CI, 19.7-39.8 hairs/cm2]); 5 mg/d of minoxidil was significantly more efficacious than 1 mg/d of finasteride (mean difference, 10.4 hairs/cm2; 95% CI, 2.2-18.6 hairs/cm2). The greatest increase in total hair count at 48 weeks (ie, third end point) was with 5 mg/d of finasteride, which was significantly more efficacious than 2% topical minoxidil (mean difference, 20.7 hairs/cm2; 95% CI, 9.5-31.9 hairs/cm2). The greatest increase in terminal hair count at 48 weeks (ie, fourth end point) was with 1 mg/d of finasteride, which was significantly more effective than topical minoxidil (in 2% [mean difference, 32.1 hairs/cm2; 95% CI, 23.9-40.3 hairs/cm2] and 5% [mean difference, 26.2 hairs/cm2; 95% CI, 16.2-36.2 hairs/cm2]).Conclusions and relevanceAs efficacy data from head-to-head trials accumulate, there could be a better sense of the relative efficacy of the different doses of the 5-α reductase inhibitors and minoxidil. The findings of this meta-analysis contribute to the comparative effectiveness literature for AGA therapies with regard to the compared interventions.
| S-EPMC8811710 | biostudies-literature
Project description:Androgenetic alopecia (AGA) is a common clinical condition, affecting over 200 million people globally each year. For decades, Minoxidil (Mi) tincture has been the primary treatment for this disease, but its low utilization rate and significant side effects necessitate new therapeutic strategies. Nitric oxide (NO) is a signaling molecule in various physiological processes, including vasodilation, immune responses, and cell proliferation. Herein, we constructed a hyaluronic acid liposome (HL) complex as a novel transdermal delivery system (HL@Mi/NONOate) for NO and Mi, which displayed promising transdermal and hair-regrowth effects. In-depth mechanistic studies revealed three potential pathways of the synergistic AGA therapy. First, NO promoted capillary dilation and accelerated blood flow, thus achieving efficient penetration of Mi. Due to the structural advantage of liposomes, the residence time of the Mi in the skin was prolonged. Moreover, HL@Mi/NONOate promoted cell proliferation and angiogenesis, and upregulated the expression of regulatory factors involved in follicle stem cell differentiation. In the AGA model, HL@Mi/NONOate down-regulated the expression of inflammatory factors, inhibiting the inflammation of follicle and improving the microenvironment of hair regrowth. Concurrently, HL@Mi/NONOate upregulated the expression of Ki67 and PCNA proteins in follicle tissues, inducing follicle regeneration and development, ultimately achieving the synergistic multimodal AGA therapy.
| S-EPMC10582348 | biostudies-literature
Project description:BackgroundOral 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.ObjectivesTo evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride.MethodsThis 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.ResultsOf 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.ConclusionTopical 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.
| S-EPMC9297965 | biostudies-literature
Project description:INTRODUCTION:Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia. METHODS:In this randomized double-blind study, patients aged???18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp. RESULTS:All screened patients (N?=?100) were enrolled and randomized to TP (n?=?33), RP1 (n?=?33), or RP2 (n?=?34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups. CONCLUSIONS:Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations. TRIAL REGISTRATION:Clinical Trial Registry of India; CTRI/2018/11/016431.
| S-EPMC7211774 | biostudies-literature
Project description:The most prevalent kind of alopecia, androgenetic alopecia, commonly known as male or female pattern hair loss, affects both men and women, with the frequency rising with advancing years. Even though practicing dermatologists and hair experts frequently encounter it, it might be one of the most challenging disorders to treat since choosing a course of action frequently requires a comprehensive analysis of several variables and moral judgment. Effectiveness, side effect profiles, practicability, promoting compliance, and treatment cost are the most important factors to take into account, especially given the chronic nature of androgenetic alopecia. A clinician's ability to select the optimum course of treatment for each patient may be constrained and clouded by their knowledge base, experience, and financial compensation. A search was done to find research on the effectiveness of topical finasteride therapy, including clinically pertinent case reports and papers. Only topical minoxidil and oral finasteride are now approved by the Food and Drug Administration and the European Medicines Agency for the treatment of androgenetic alopecia. Despite being effective for hair regeneration, systemic use of finasteride is accompanied by adverse effects that prevent long-term use. Investigating topical finasteride as another possible treatment plan may be fruitful. Early research on the use of topical finasteride is safe and encouraging, despite its limitations. More research on drug distribution, ideal topical strength and usage regularity, adverse effects, and application for other alopecias would aid in elucidating the range of topical finasteride use.
| S-EPMC10561660 | biostudies-literature