Elise A Olsen, Frank E Dunlap, Toni Funicella, Judith A Koperski, James M Swinehart, Eduardo H Tschen, Ronald J Trancik
A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men.
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.
V H Price, E Menefee, P C Strauss
Changes in hair weight and hair count in men with androgenetic alopecia, after application of 5% and 2% topical minoxidil, placebo, or no treatment.
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.
Ryoji Tsuboi, Osamu Arano, Tooru Nishikawa, Hidekazu Yamada, Kensei Katsuoka
Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men.
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.
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
Finasteride increases anagen hair in men with androgenetic alopecia.
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.
Vera H Price, Emory Menefee, Matilde Sanchez, Keith D Kaufman
Changes in hair weight in men with androgenetic alopecia after treatment with finasteride (1 mg daily): three- and 4-year results.
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.
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
Finasteride in the treatment of Japanese men with male pattern hair loss.
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.
Aditya K Gupta, Andrew Charrette
The efficacy and safety of 5α-reductase inhibitors in androgenetic alopecia: a network meta-analysis and benefit-risk assessment of finasteride and dutasteride.
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.
Yuichiro Tsunemi, Ryokichi Irisawa, Hiromu Yoshiie, Betsy Brotherton, Hisahiro Ito, Ryoji Tsuboi, Makoto Kawashima, Michael Manyak, ARI114264 Study Group
Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia.
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.
