Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men

Minoxidil is efficacious in inducing hair growth in patients with androgenetic alopecia by inducing hair follicles to undergo transition from the early to late anagen phase. Although the efficacy of 1% topical minoxidil has been confirmed in Japan, no controlled study of 5% topical minoxidil has been conducted using male Japanese subjects. The objective of this trial was to verify the superiority in clinical efficacy of 5% topical minoxidil to 1% topical minoxidil in a double-blind controlled study with male, Japanese androgenetic alopecia patients as the subjects. The trial included 300 Japanese male patients aged 20 years or older with androgenetic alopecia who were administered either 5% topical minoxidil ( n  = 150) or 1% topical minoxidil ( n  = 150) for 24 weeks. The mean change from the baseline in non-vellus hair/cm², the primary efficacy variable, was 26.4 ( n  = 142) in the 5% topical minoxidil group and 21.2 ( n  = 144) in the 1% topical minoxidil group at 16 weeks, the main time point for the evaluation. The difference between the groups was significant ( P  = 0.020). The incidence of adverse events was 8.7% (13/150) in the 5% group and 5.3% (8/150) in the 1% group, with no significant difference between the groups (χ²-test: P  = 0.258). Our findings confirmed the superiority of 5% topical minoxidil to 1% topical minoxidil in treating Japanese men with androgenetic alopecia.     

Clinical utility and validity of minoxidil response testing in androgenetic alopecia

Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3–6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA.     

The clinical effect of JetpPeel-assisted topical minoxidil in the treatment of androgenetic alopecia: A randomized pilot study

Objective: We used JetPeel, combined with topical minoxidil to treat patients with AGA, in order to observe whether the JetPeel can accelerate the recovery of the disease and find a new method for AGA treatment. Method: Thirty patients who met the standard were included in the study. The patients were randomly divided into three groups. The first group was treated with JetPeel-assisted topical minoxidil. The second group received topical minoxidil monotherapy. The third group was not given any treatment. We used objective evaluation (amount and diameter of hair, oil secretion level) and subjective evaluation (hair growth score marked by dermatologist and patient) to evaluate the hair growth condition before treatment and every other month. The calculated p values of less than 0.05 were accepted as significant. Result: All of the 30 patients finished the study. There was no difference in age, sex, and duration and severity of the disease among groups prior to treatment (p > 0.05). And there was greater improvement in scores of hair growth in the first group compared to the second and third group, which was statistically significant (p < 0.05). Conclusion: Compared with topical minoxidil monotherapy, JetPeel-assisted topical minoxidil is more effective during the treatment of androgenetic alopecia.     

Topical 5% minoxidil versus combined erbium YAG laser and topical 5% minoxidil in androgenetic alopecia: A randomized controlled trial

Background

Androgenetic alopecia (AGA) is the most common type of hair loss in men, and several treatment options have been proposed for it. Fractional ablative erbium YAG laser can promote hair growth through trans-epidermal drug delivery and the thermal stimulation of hair follicles; this study therefore aims to evaluate minoxidil alone and in combination with fractional ablative erbium YAG laser in male patients with AGA.

Methods

This study was performed on 30 male patients with moderate to severe AGA. Patients were equally randomized into two groups, and the intervention group was treated with 1 mL of topical 5% minoxidil twice daily and six sessions of 2940-nm ablative fractional erbium YAG laser, and the control group received topical 5% minoxidil alone. The assessment entailed photography, dermoscopy, and patient satisfaction based on a 7-point grading scale.

Results

Both groups showed statistically significant improvements in terms of patient satisfaction, photography, and dermoscopy scores. The group receiving a combination of laser and minoxidil treatment obtained a higher dermoscopy score than the patients receiving minoxidil alone (p-value = 0.016). Nonetheless, there was no difference between the two groups in terms of the photography score (p-value = 0.13).

Conclusion

Laser treatment can stimulate the hair follicles and also enhance the dermal delivery of minoxidil, which was found to be associated with slightly better outcomes in this study.     

Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients

Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy.     

Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia

Topical minoxidil is the most common drug used for the treatment of androgenetic alopecia (AGA) in men and women. Although topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low at 30–40%. To observe significant improvement in hair growth, minoxidil is typically used daily for a period of at least 3–4 months. Due to the significant time commitment and low response rate, a biomarker for predicting patient response prior to therapy would be advantageous. Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. We hypothesized that SULT1A1 enzyme activity in the hair follicle correlates with minoxidil response for the treatment of AGA. Our preliminary retrospective study of a SULT1A1 activity assay demonstrates 95% sensitivity and 73% specificity in predicting minoxidil treatment response for AGA. A larger prospective study is now under way to further validate this novel assay.     

Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia

Two percent topical minoxidil is the only US Food and Drug Administration‐approved drug for the treatment of female androgenetic alopecia (AGA). Its success has been limited by the low percentage of responders. Meta‐analysis of several studies reporting the number of responders to 2% minoxidil monotherapy indicates moderate hair regrowth in only 13–20% of female patients. Five percent minoxidil solution, when used off‐label, may increase the percentage of responders to as much as 40%. As such, a biomarker for predicting treatment response would have significant clinical utility. In a previous study, Goren et al. reported an association between sulfotransferase activity in plucked hair follicles and minoxidil response in a mixed cohort of male and female patients. The aim of this study was to replicate these findings in a well‐defined cohort of female patients with AGA treated with 5% minoxidil daily for a period of 6 months. Consistent with the prior study, we found that sulfotransferase activity in plucked hair follicles predicts treatment response with 93% sensitivity and 83% specificity. Our study further supports the importance of minoxidil sulfation in eliciting a therapeutic response and provides further insight into novel targets for increasing minoxidil efficacy.     

不同深度微针联合外用米诺地尔酊治疗男性雄激素性脱发的疗效观察

目的 观察不同深度微针联合外用米诺地尔酊治疗男性雄激素性脱发的临床疗效以及安全性。方法 纳入2020年6月至2021年6月河南科技大学第一附属医院皮肤科门诊男性雄激素性脱发患者90例,随机分为A组(n=30)、B组(n=30)和C组(n=30)。A组仅外用5%米诺地尔酊治疗,B组予0.5 mm深度电动微针针刺联合外用米诺地尔酊治疗;C组予1 mm深度电动微针针刺联合外用米诺地尔酊治疗。治疗12周后观察临床疗效及不良反应情况。结果 治疗12周后,三组患者毛发密度、毛发直径均较治疗前明显改善(均P<0.05),B组和C组均明显优于A组(均P<0.05)。B组和C组患者治疗后自我评估头发生长改善评分均明显优于A组(均P<0.05)。A、B、C三组患者不良反应发生率分别为6.67%、6.67%和26.67%,C组明显高于A组和B组(χ²=6.92,P=0.031)。结论 0.5 mm深度微针针刺联合外用米诺地尔酊治疗男性雄激素性脱发疗效显著,安全性好,是男性雄激素性脱发患者新的治疗选择。     

The effectiveness of combination therapies for androgenetic alopecia: A systematic review and meta‐analysis

Androgenetic alopecia (AGA) is the most common type of baldness affecting both men and women. Studies investigating combination therapies for AGA reported greater efficacy than monotherapy but without rigorous examination. The authors performed a meta‐analysis and systemic review to further verify the evidence. To evaluate the effectiveness of three common combination therapies of minoxidil with finasteride, low‐level laser light therapy (LLLT) or microneedling versus minoxidil monotherapy. We conducted a systematic review of randomized controlled trials (RCTs) of combination therapies consisting of topical minoxidil for AGA through April 2020. Quality assessment and data analysis were performed by Review Manager 5.3. Fifteen studies met the inclusion criteria involving a total of 1172 AGA patients. We conducted meta‐analysis for three groups of combined treatment separately, and all were superior to monotherapy in terms of global photographic assessment (P < .05). Combination of LLLT or microneedling with minoxidil also showed significant increase in hair count (P < .05) compared to monotherapy. The present study suggests that combination therapy could be an effective, safe and promising option for the treatment of AGA. However, more RCTs are needed to further investigate and confirm the efficacy of combined treatment.     

Effects of minoxidil 2% vs. cyproterone acetate treatment on female androgenetic alopecia: a controlled, 12-month randomized trial

BACKGROUND: Hormone studies have demonstrated the androgen-dependent character of female androgenetic alopecia, but there have been few controlled studies of therapies for alopecia in women. OBJECTIVES: To compare topical minoxidil 2% and cyproterone acetate in the treatment of female alopecia. METHODS: Sixty-six women with female-pattern alopecia were randomly assigned for 12 cycles into two groups, 33 received two local applications (2 mL day-1) of topical minoxidil 2% plus combined oral contraceptive and 33 received cyproterone acetate 52 mg day-1 plus ethinyl oestradiol 35 microg for 20 of every 28 days. RESULTS: A mean reduction of 2.4 +/- 6.2 per 0.36 cm2 in hairs of diameter > 40 microm was observed in the cyproterone acetate group (P = 0.05) and a mean increase of 6.5 +/- 9 per 0.36 cm2 in the minoxidil group (P < 0.001). Comparison of the total number of hairs at 12 months and the body mass index (BMI) revealed a borderline positive correlation in the cyproterone acetate group (r = 0.39, P = 0.06) and a negative correlation in the minoxidil group (r = -0.42, P < 0.05). No significant difference was observed in the total number of hairs among cyproterone acetate patients according to the presence or absence of other symptoms of hyperandrogenism, whereas in the minoxidil group, the total number of new hairs was higher in patients with isolated alopecia (Delta = 8.1; P < 0.05). Variations in scalp seborrhoea were significant in both groups, but the result was better (for acne and hirsutism as well) in the cyproterone acetate group than in the minoxidil group (P < 0.001). CONCLUSIONS: Minoxidil treatment was more effective in the absence of other signs of hyperandrogenism, hyperseborrhoea, and menstrual cycle modifications when the BMI was low, and when nothing argued in favour of biochemical hyperandrogenism. Cyproterone acetate treatment was more effective when other signs were present and when the BMI was elevated, factors that favoured a diagnosis of biochemical hyperandrogenism.     

Comparison of the efficacy and safety of topical minoxidil and topical alfatradiol in the treatment of androgenetic alopecia in women

Background: Two drugs which are approved for the treatment of androgenetic alopecia in women in Germany were compared with regard to their influence on hair growth. Patients and Methods: Patients were randomized to group I (n = 52) who used 2% minoxidil solution twice daily for a period of 12 months or to group II (n = 51) who used 0.025% alfatradiol solution once daily for 6 months and were then switched to 2% minoxidil solution for months 7–12. Changes in hair growth parameters were determined using the TrichoScan. Results:Topical treatment with 2% minoxidil solution for 6 months resulted in a significant increase of cumulative hair thickness (p < 0.0001) and absolute hair density (p ≤ 0.0025), whereas these parameters of hair growth remained nearly unchanged after 6 months of treatment with alfatradiol solution. Evaluation of the same parameters from month 7 to month 12 demonstrated that 12 months minoxidil treatment resulted in an increasing stabilization (group I). After the alfatradiol→minoxidil switch in group II a significant increase in cumulative hair thickness (p < 0.0001) and absolute hair density (p < 0.0001) was achieved. Both study medications were well tolerated. Conclusions: Treatment with minoxidil can induce an increase in hair density and hair thickness,whereas treatment with alfatradiol results in deceleration or stabilization of hair loss.     

Comparative efficacy of various treatment regimens for androgenetic alopecia in men

Our understanding of the aetiology of androgenetic alopecia (AGA) has substantially increased in recent years. As a result, several treatment modalities have been tried with promising results especially in early stages of AGA. However, as far as has been ascertained, there is no comprehensive study comparing the efficacy of these agents alone and in combination with each other. One hundered male patients with AGA of Hamilton grades II to IV were enrolled in an open, randomized, parallel-group study, designed to evaluate and compare the efficacy of oral finasteride (1 mg per day), topical 2% minoxidil solution and topical 2% ketoconazole shampoo alone and in combination. They were randomized into four groups. Group I (30 patients) was administered oral finasteride, Group II (36 patients) was given a combination of finasteride and topical minoxidil, Group III (24 patients) applied minoxidil alone and Group IV (10 patients) was administered finasteride with topical ketoconazole. Treatment efficacy was assessed on the basis of patient and physician assessment scores and global photographic review during the study period of one year. At the end of one year, hair growth was observed in all the groups with best results recorded with a combination of finasteride and minoxidil (Group II) followed by groups IV, I and III. Subjects receiving finasteride alone or in combination with minoxidil or ketoconazole showed statistically significant improvement (p<0.05) over minoxidil only recipients. No signifcant side-effects related to the drugs were observed. In conclusion, it is inferred that the therapeutic efficacy is enhanced by combining the two drugs acting on different aetiological aspects of AGA.     

5%米诺地尔酊联合670nm+830nm激光治疗雄激素性脱发的疗效评价

目的：评价670nm+830nm激光联合5%米诺地尔酊对雄激素性秃发的疗效。方法：将60例雄激素性秃发患者随机分为治疗组与对照组：对照组单纯外用5%米诺地尔酊治疗,治疗组在对照组基础上加用670nm+830nm激光照射治疗,每周治疗2次,30分钟/次,6个月后进行疗效评定。结果：实际完成治疗及观察人数58例（实验组2例失访),治疗组总有效率为85.7％,对照组为53.3％,差异显著（χ2=10.02 ,P<0.01）,两组不良反应发生率无显著差异(χ2=0 ,P>0.05）。结论：670nm+830nm激光联合5%米诺地尔酊治疗雄激素性秃发安全、有效,可推广应用。     

Intradermal injections with 0.5% minoxidil for the treatment of female androgenetic alopecia: A randomized,placebo‐controlled trial

Female androgenetic alopecia is one cause of alopecia in women, although the ideal treatment for this condition remains far from defined. The objective of this study was to evaluate the efficacy and safety of intradermal injections with 0.5% minoxidil for the management of female androgenetic alopecia in a randomized, placebo‐controlled trial. A total of 54 women diagnosed with female androgenetic alopecia were divided into two groups: one group received intradermal injections of 0.5% minoxidil, and the other received 0.9% saline. Biopsy, trichogram, Trichoscan (Tricholog GmbH, Freiburg, Germany), and self‐assessment findings were used to evaluate the outcomes of treatment with minoxidil. In the treated group, there was a significant increase in the terminal‐to‐vellus hair ratio (P < .001) and in the percentage of anagen hairs (P = .048) and an improvement in hair loss and volume (P = .021 and P = .028, respectively). These results show that intradermal injections with minoxidil were more effective than placebo (P < .001) in the treatment of female androgenetic alopecia with a good safety profile.     

Evaluation of platelet-rich plasma plus basic fibroblast growth factor combined with minoxidil in the treatment of androgenetic alopecia: A randomized controlled trial

Background

Platelet-rich plasma plus basic fibroblast growth factor (PRPF) has been confirmed to be a safe and valuable therapy for androgenetic alopecia (AGA). However, the efficacy of PRPF combined with minoxidil treatment remains unknown.

Objective

To assess the efficacy of combined PRPF and minoxidil treatment for AGA.

Methods

In this prospective, randomized controlled trial, 75 patients with AGA were randomly divided into three groups and were administered the following treatments: Group 1, direct intradermal PRPF injection; Group 2, topical minoxidil 5% twice daily; and Group 3, PRPF injection combined with minoxidil. The PRPF injection was performed three times, 1 month apart. Hair growth parameters were evaluated using a trichoscope until the sixth month of the study. Patient satisfaction and side effects were recorded during the follow-up.

Results

All patients showed improvements (p < 0.05) in hair count, terminal hair, and decrease in telogen hair ratio after treatment. The efficacy of PRPF complex therapy revealed significant improvements (p < 0.05) in hair count, terminal hair and growth rate, compared with monotherapy.

Limitations

Small sample size, short follow-up time and lack of quantification of GFs in PRPF.

Conclusion

The effect of complex therapy exceed both the effects of PRPF monotherapy and minoxidil treatment, which can be a beneficial AGA treatment strategy.     

Topical ketoconazole for the treatment of androgenetic alopecia: A systematic review

Androgenetic alopecia (AGA) is common and associated with significant psychosocial distress. Treatment options are needed for patients that do not adequately respond to first line treatments of finasteride or minoxidil. Topical ketoconazole has been proposed as a promising treatment. The goal of this systematic review was to evaluate the efficacy of topical ketoconazole in the treatment of AGA. A systematic literature search was conducted within the MEDLINE database using the key terms “ketoconazole” and “alopecia.” Forty‐seven papers were screened for inclusion, of which nine were assessed for eligibility. Seven articles were included in the qualitative synthesis, including two animal studies (total of 40 participants) and five human studies (total of 318 participants). Murine studies demonstrated a significant increase in mean ratio of hair regrowth to denuded area in the ketoconazole treatment groups compared to controls. Human studies reported increased hair shaft diameter following ketoconazole use. One study reported a significant increase in pilary index (percent anagen phase × diameter) following treatment. Studies also demonstrated clinical improvement of AGA based on photographic assessment and subjective evaluation. Topical ketoconazole is a promising adjunctive or alternative therapy in the treatment of AGA. Randomized controlled trials are needed.