今日の臨床サポート

男性型脱毛症

著者: 中村元信 産業医科大学 皮膚科学教室

監修: 戸倉新樹 掛川市・袋井市病院企業団立 中東遠総合医療センター 参与/浜松医科大学 名誉教授

著者校正/監修レビュー済:2019/05/09
参考ガイドライン:
男性型および女性型脱毛症診療ガイドライン2017年版
患者向け説明資料

概要・推奨   

  1. 男性型脱毛症に対して、5%ミノキシジル外用は推奨される(推奨度2)
  1. 男性型脱毛症に対して、フィナステリド内服は推奨される(推奨度2)
  1. 男性型脱毛症に対して、デュタステリド内服は推奨される(推奨度2)
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
中村元信 : 特に申告事項無し[2021年]
監修:戸倉新樹 : 講演料(田辺三菱,サノフィ,マルホ,協和キリン),研究費・助成金など(ノバルティス,レオファーマ)[2021年]

改訂のポイント:
  1. 男性型および女性型脱毛症診療ガイドライン2017年版に基づき、主にデュタステリドの内服について改訂を行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 男性型脱毛症は「若ハゲ」と呼ばれており、思春期以降に進行する頻度の高い状態である。
  1. 男性型脱毛症は「たかがハゲ」と軽視されがちだが、社会の成熟とともに治療への欲求が高まっている。
  1. 鑑別すべき疾患は円形脱毛症や休止期脱毛症など多岐にわたるが、特徴的な部位や、軟毛化を伴っていることが多いことから、鑑別は比較的容易である。
  1. 内服薬、外用薬とも効果発現までに長期間を要し、治療を最低6カ月は継続することが必要である。
 
男性型脱毛症:前頭部から頭頂部にかけての脱毛斑前頭部から頭頂部にかけ軟毛化を認める。

ケースの説明
病 歴:40歳代男性、頭部の脱毛斑の拡大を主訴に受診。
診 察:前頭部から頭頂部にかけ毛髪の色が薄くなり、細く短くなる軟毛化を認める。
治 療:フィナステリド内服治療と5%ミノキシジル外用を併用した。
転 帰:1年後、頭頂部の軟毛化は改善し、脱毛斑は目立たなくなった。
コメント:男性型脱毛症の治療には長期間かかり、治療を辛抱強く継続してもらうことが肝要である。治療を中止すると悪化する場合が多い。

出典

img1:  著者提供
 
 
問診・診察のポイント  
  1. 男性型脱毛症は思春期以降、場合により10歳代から始まり、治療をしなければ徐々に進行する。

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文献 

著者: Elise A Olsen, Frank E Dunlap, Toni Funicella, Judith A Koperski, James M Swinehart, Eduardo H Tschen, Ronald J Trancik
雑誌名: J Am Acad Dermatol. 2002 Sep;47(3):377-85.
Abstract/Text BACKGROUND: Topical minoxidil solution 2% stimulates new hair growth and helps stop the loss of hair in individuals with androgenetic alopecia (AGA). Results can be variable, and historical experience suggests that higher concentrations of topical minoxidil may enhance efficacy.
OBJECTIVE: The purpose of this 48-week, double-blind, placebo-controlled, randomized, multicenter trial was to compare 5% topical minoxidil with 2% topical minoxidil and placebo in the treatment of men with AGA.
METHODS: A total of 393 men (18-49 years old) with AGA applied 5% topical minoxidil solution (n = 157), 2% topical minoxidil solution (n = 158), or placebo (vehicle for 5% solution; n = 78) twice daily. Efficacy was evaluated by scalp target area hair counts and patient and investigator assessments of change in scalp coverage and benefit of treatment.
RESULTS: After 48 weeks of therapy, 5% topical minoxidil was significantly superior to 2% topical minoxidil and placebo in terms of change from baseline in nonvellus hair count, patient rating of scalp coverage and treatment benefit, and investigator rating of scalp coverage. Hair count data indicate that response to treatment occurred earlier with 5% compared with 2% topical minoxidil. Additionally, data from a patient questionnaire on quality of life, global benefit, hair growth, and hair styling demonstrated that 5% topical minoxidil helped improve patients' psychosocial perceptions of hair loss. An increased occurrence of pruritus and local irritation was observed with 5% topical minoxidil compared with 2% topical minoxidil.
CONCLUSION: In men with AGA, 5% topical minoxidil was clearly superior to 2% topical minoxidil and placebo in increasing hair regrowth, and the magnitude of its effect was marked (45% more hair regrowth than 2% topical minoxidil at week 48). Men who used 5% topical minoxidil also had an earlier response to treatment than those who used 2% topical minoxidil. Psychosocial perceptions of hair loss in men with AGA were also improved. Topical minoxidil (5% and 2%) was well tolerated by the men in this trial without evidence of systemic effects.

PMID 12196747  J Am Acad Dermatol. 2002 Sep;47(3):377-85.
著者: V H Price, E Menefee, P C Strauss
雑誌名: J Am Acad Dermatol. 1999 Nov;41(5 Pt 1):717-21.
Abstract/Text Quantitative estimation of hair growth using hair weight and number was recorded for 120 weeks in 4 groups of 9 men with androgenetic alopecia. Three double-blind groups applied either 2% or 5% minoxidil solution, or vehicle. The fourth group, unblinded, received no treatment. Measurements of hair weight and number were continued for 96 weeks, when treatment (if any) was stopped, though measurements were continued for another 24 weeks. Although not compared statistically, the placebo and untreated groups behaved in a similar fashion. In contrast, the 5% and 2% minoxidil treatment groups showed a statistically significant increase in mean percentage change in interval weight from baseline compared with placebo; results for number counts were usually less significant. Over 96 weeks, topical minoxidil induced and maintained an increase in interval weight over baseline of about 30%. After treatment was stopped, hair weight and number counts for the minoxidil groups returned to about the same levels as placebo in 24 weeks.

PMID 10534633  J Am Acad Dermatol. 1999 Nov;41(5 Pt 1):717-21.
著者: Ryoji Tsuboi, Osamu Arano, Tooru Nishikawa, Hidekazu Yamada, Kensei Katsuoka
雑誌名: J Dermatol. 2009 Aug;36(8):437-46. doi: 10.1111/j.1346-8138.2009.00673.x.
Abstract/Text 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/cm(2), 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 (chi(2)-test: P = 0.258). Our findings confirmed the superiority of 5% topical minoxidil to 1% topical minoxidil in treating Japanese men with androgenetic alopecia.

PMID 19691748  J Dermatol. 2009 Aug;36(8):437-46. doi: 10.1111/j.1346-・・・
著者: D Van Neste, V Fuh, P Sanchez-Pedreno, E Lopez-Bran, H Wolff, D Whiting, J Roberts, D Kopera, J J Stene, S Calvieri, A Tosti, E Prens, M Guarrera, P Kanojia, W He, K D Kaufman
雑誌名: Br J Dermatol. 2000 Oct;143(4):804-10.
Abstract/Text BACKGROUND: The growth of scalp hair is a cyclical process of successive phases of growth (anagen) and rest (telogen). In previous clinical trials in men with androgenetic alopecia, treatment with finasteride increased scalp hair counts in a defined area (i.e. increased hair density).
OBJECTIVES: The current study used a phototrichogram methodology to assess the effect of finasteride on the phases of the hair growth cycle.
PATIENTS/METHODS: Two hundred and twelve men, age 18-40 years, with androgenetic alopecia were randomized to receive finasteride 1 mg daily or placebo for 48 weeks. At baseline and at 24 and 48 weeks, macrophotographs were taken to measure total and anagen hair count in a 1-cm(2) target area of the scalp.
RESULTS: At baseline, mean total and anagen hair counts in the finasteride group were 200 and 124 hairs, respectively (% anagen = 62%) and the anagen to telogen ratio was 1.74 (geometric mean). In the placebo group, the respective values were 196 and 119 hairs (% anagen = 60%) and 1.57. At week 48, the finasteride group had a net improvement (mean +/- SE) compared with placebo in total and anagen hair counts of 17.3 +/- 2.5 hairs (8.3% +/- 1.4%) and 27.0 +/- 2.9 hairs (26% +/- 3.1%), respectively (P < 0.001). Furthermore, treatment with finasteride resulted in a net improvement in the anagen to telogen ratio of 47% (P < 0.001). In this study, treatment with finasteride 1 mg day(-1) for 48 weeks increased both total and anagen hair counts, and improved the anagen to telogen ratio.
CONCLUSIONS: These data provide direct evidence that finasteride 1 mg daily promotes the conversion of hairs into the anagen phase. These data support that finasteride treatment results in favourable effects on hair quality that contribute to the visible improvements in hair growth observed in treated patients.

PMID 11069460  Br J Dermatol. 2000 Oct;143(4):804-10.
著者: Vera H Price, Emory Menefee, Matilde Sanchez, Keith D Kaufman
雑誌名: J Am Acad Dermatol. 2006 Jul;55(1):71-4. doi: 10.1016/j.jaad.2005.07.001. Epub 2006 May 3.
Abstract/Text BACKGROUND: We previously reported the effects of finasteride on scalp hair weight and count over a 2-year period in men with androgenetic alopecia (AGA).
OBJECTIVE: Our purpose was to evaluate the effects of finasteride on hair weight and count over 4 years in men with AGA.
METHODS: Men with AGA were randomized to receive finasteride (1 mg/d) or placebo for 192 weeks. Results of the second (weeks 96-144) and third (weeks 144-192) extension periods are reported.
RESULTS: Finasteride increased hair weight at 144 and 192 weeks (week 192: finasteride, 21.6% increase from baseline; placebo, 24.5% decrease from baseline; net increase in hair weight for finasteride vs placebo = 46.0%, P < .001). Hair count also increased with finasteride at 144 and 192 weeks (week 192: finasteride, 7.2% increase from baseline; placebo, 13.0% decrease from baseline; net increase in hair count for finasteride vs placebo = 20.3%, P < .05). Finasteride was generally well tolerated.
LIMITATIONS: Because this study was extended from its original 48-week duration to nearly 4 years, the sample size available for analysis decreased with time.
CONCLUSION: Long-term finasteride treatment led to sustained improvement in hair weight compared with placebo. Hair weight increased to a larger extent than hair count, implying that factors other than the number of hairs, such as increased growth rate (length) and thickness of hairs, contribute to the beneficial effects of finasteride in treated men.

PMID 16781295  J Am Acad Dermatol. 2006 Jul;55(1):71-4. doi: 10.1016/j・・・
著者: Makoto Kawashima, Nobukazu Hayashi, Atsuyuki Igarashi, Hirohito Kitahara, Mizue Maeguchi, Atsuko Mizuno, Yasuko Murata, Toshitatsu Nogita, Kiyoshi Toda, Ryoji Tsuboi, Rie Ueki, Mina Yamada, Masashi Yamazaki, Takuma Matsuda, Yutaka Natsumeda, Kihito Takahashi, Shotaro Harada
雑誌名: Eur J Dermatol. 2004 Jul-Aug;14(4):247-54.
Abstract/Text Finasteride is a type 2 5 alpha-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss (androgenetic alopecia). The objective of this study was to identify the optimal dosage of finasteride and to evaluate its efficacy and safety in the treatment of Japanese men with male pattern hair loss. In this double- blind randomized study, 414 Japanese men with male pattern hair loss received finasteride 1 mg (n = 139), finasteride 0.2 mg (n = 137), or placebo (n = 38) once daily for 48 weeks. Efficacy was evaluated by global photographic assessment, patient self-assessment, and investigator assessment. All efficacy endpoints showed significant improvement with finasteride therapy by 12 weeks (p < 0.05 versus placebo). At 48 weeks, 58%, 54%, and 6% of men in the finasteride 1 mg, finasteride 0.2 mg, and placebo groups, respectively, had improved based on assessments of global photographs. All efficacy endpoints were numerically superior for the 1 mg dose over the 0.2 mg dose at 48 weeks. Finasteride treatment was generally well tolerated. Finasteride 1 mg\day slows hair loss and improves hair growth in Japanese men with male pattern hair loss.

PMID 15319158  Eur J Dermatol. 2004 Jul-Aug;14(4):247-54.
著者: Aditya K Gupta, Andrew Charrette
雑誌名: J Dermatolog Treat. 2014 Apr;25(2):156-61. doi: 10.3109/09546634.2013.813011. Epub 2013 Jul 5.
Abstract/Text INTRODUCTION: In the light of post-marketing reports of persistent sexual dysfunction with the use of finasteride, analysis of the extent of risk associated with 5α-reductase inhibitor treatment for androgenetic alopecia (AGA) is warranted. This study sought to evaluate the efficacy of 5α-reductase inhibitors using the outcomes hair count, global photographic assessment and patient self-assessment and evaluate the benefits of treatment versus the risk of global sexual dysfunction.
METHODS: A systematic review identified all relevant randomized controlled trials of finasteride 1 mg, 5 mg and dutasteride 0.5 mg. The efficacy outcome hair count was analyzed using pair-wise meta-analysis, while the efficacy outcomes global photographic assessment and patient self-assessment as well as the safety outcome global sexual dysfunction were analyzed through network meta-analyses. A benefit-risk assessment was also performed.
RESULTS: The active interventions were not significantly different than each other in efficacy and were not significantly different from placebo in eliciting sexual dysfunction. Benefit-risk analysis resulted in an arbitrary ranking due to the lack of statistically significant difference between active treatments.
DISCUSSION: Analysis results reiterate the efficacy and safety of 5α-reductase inhibitors for the treatment of AGA and may support the approval of dutasteride 0.5 mg as an additional treatment option, following further study.

PMID 23768246  J Dermatolog Treat. 2014 Apr;25(2):156-61. doi: 10.3109・・・
著者: Yuichiro Tsunemi, Ryokichi Irisawa, Hiromu Yoshiie, Betsy Brotherton, Hisahiro Ito, Ryoji Tsuboi, Makoto Kawashima, Michael Manyak, ARI114264 Study Group
雑誌名: J Dermatol. 2016 Sep;43(9):1051-8. doi: 10.1111/1346-8138.13310. Epub 2016 Feb 19.
Abstract/Text Androgenetic alopecia is an androgen-induced pattern of progressive hair loss, which occurs in genetically predisposed people. This study aimed to determine long-term safety, tolerability and efficacy of dutasteride 0.5 mg, an inhibitor of 5-α-reductase, in Japanese male patients with androgenetic alopecia. This was a multicenter, open-label, prospective outpatient study (clinicaltrials.gov NCT01831791, GSK identifier ARI114264) in which patients took dutasteride 0.5 mg p.o. once daily for 52 weeks. Primary end-points included adverse event assessment, incidence of drug-related adverse event and premature discontinuations. Secondary end-points included hair growth, hair restoration and global improvement in hair. A total of 120 patients were enrolled, of whom 110 completed 52 weeks of treatment. Nasopharyngitis, erectile dysfunction and decreased libido were the most frequently reported adverse events and most adverse events were mild. Drug-related adverse events were reported with an incidence of 17%, none of which led to study withdrawal. Hair growth (mean target area hair count at week 52), hair restoration (mean target area hair width at week 52) and global appearance of hair (mean of the median score at week 52) improved from baseline during the study. As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population.

© 2016 Japanese Dermatological Association.
PMID 26893187  J Dermatol. 2016 Sep;43(9):1051-8. doi: 10.1111/1346-81・・・

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