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Long-term (10-year) efficacy of finasteride in 523 Japanese men with androgenetic alopecia

Authors:
  • Tokyo Memorial Clinic
Research Article
Clinical Research and Trials
Clin Res Trials, 2019 doi: 10.15761/CRT.1000273
ISSN: 2059-0377
Volume 5: 1-5
Long-term (10-year) ecacy of nasteride in 523 Japanese
men with androgenetic alopecia
Masayuki Yanagisawa1-3, Hiroshi Fujimaki2,4, Akira Takeda1,2, Mitsuru Nemoto1, Takayuki Sugimoto1 and Akio Sato1-3*
1Department of Plastic and Aesthetic Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan
2Tokyo Memorial Clinic, 2F Yamaha Building, 2-16-7 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
3Department of Plastic and Reconstructive Surgery, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
4Department of Plastic and Reconstructive Surgery, Tokyo Women’s Medical University, 8-1 Kawada-cyo, Shinjuku-ku, Tokyo 162-8666, Japan
Abstract
Finasteride is a standard medical treatment for androgenetic alopecia; however, no long-term study of up to 10 years has been performed in Japan. erefore, we
evaluated the ecacy and safety of 1 mg/day nasteride in 532 Japanese men who were treated for androgenetic alopecia for 10 years. We performed subjective
evaluations, using questionnaires administered to patients, in addition to the objective evaluation by doctors. e ecacy was assessed using the Norwood-Hamilton
scale and modied global photographic assessment score, the standardized 7-point rating score using scalp photographs. For the Norwood-Hamilton classications,
stages IIa and IIv were combined as II, IIIa and IIIv were combined as III, IVa was combined as IV, and Va was combined as V. e proportions of patients with
improvement (score ≥ 5) and prevention of disease progression (score ≥ 4) were 91.5% and 99.1%, respectively. e Norwood-Hamilton classication grading
improved by approximately 1 grade from 3.35 ± 1.11 to 2.55 ± 1.30 after the 10-year treatment. e groups that showed Norwood-Hamilton: I/II/III and IV/V/VI/
VII at the rst visit showed statistically signicant dierences in the modied global photographic assessment score at the 10-year treatment subjective evaluation
(6.27 ± 0.62 vs 5.52 ± 0.78, P<0.001). Furthermore, the quantitative analysis of the objective evaluation using the questionnaire was also signicantly dierent
(P<0.001). During the study period, no serious adverse reaction was recognized. Long-term (10-year) treatment with 1 mg/day nasteride in Japanese men with
androgenetic alopecia showed high ecacy in subjective and objective evaluations.
*Correspondence to: Akio Sato, MD, PhD. Tokyo Memorial Clinic, 2F Yamaha
Building, 2-16-7 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan, E-mail: drsato@
crux.ocn.ne.jp
Key words: androgenetic alopecia, nasteride, Japanese, long-term, modied
global photographic assessment, Norwood-Hamilton scale
Received: September 09, 2019; Accepted: September 16, 2019; Published:
September 19, 2019
Introduction
Finasteride was authorized in Japan for the treatment of
androgenetic alopecia (AGA) in 2005; subsequently, prescription of
this medication commenced. Presently, nasteride is authorized in over
60 countries and is administered to over 3 million patients for AGA.
Dihydro-testosterone (DHT) has a key role in mediating progressive
scalp hair loss in men with AGA, and nasteride blocks the conversion
of testosterone to DHT as a selective type II 5α-reductase inhibitor,
which justies its use in AGA treatment [1-3]. Although the ecacy
of AGA treatment with nasteride has been demonstrated by several
large-scale and long-term studies, [4-7] no long-term investigation
for up to 10 years has yet been conducted in Japanese subjects [8-10].
erefore, the objective of this study was to evaluate the ecacy and
safety of large-scale and long-term AGA treatment with nasteride,
which, to our knowledge, is the rst of such studies in Japan. In this
study, a subjective evaluation was conducted using a questionnaire on
AGA administered to each patient; moreover, an objective evaluation
was performed by doctors.
Methods
Study population
We examined 532 Japanese men who had been diagnosed
with AGA at the rst visit to the Tokyo Memorial Clinic Hirayama
(hereaer, “the clinic”) during the period between December 2005
and January 2009 and had been treated with 1 mg/day nasteride
for 10 years until January 2019. Furthermore, all patients answered a
questionnaire about the long-term treatment of AGA aer 10 years
treatment. Written informed consent for participation in the present
study was obtained from all patients.
Ecacy Evaluation
Objective ecacy - Scalp photographs
e ecacy was objectively assessed using the Norwood-
Hamilton scale (N-H) [11,12] and the modied global photographic
assessment score (MGPA) [13,14], (Figure 1) with the following
standardized 7-point rating score using scalp photographs: 1,
signicant disease progression; 2, moderate disease progression; 3,
slight disease progression; 4, no change; 5, slight improvement; 6,
moderate improvement; and 7, signicant improvement. In the N-H
classications, stages IIa and IIv were combined as stage II, IIIa and IIIv
were combined as III, IVa was combined as IV, and Va was combined
as V. In the MGPA assessment, we evaluated scalp photographs at
the rst visit and yearly and categorized the MGPA in every N-H
classication at the rst visit (Figure 2).
Subjective ecacy - Questionnaire
e subjective ecacy was assessed using a long-term AGA
treatment questionnaire, which was digitalized to the following
numerical rating scale (NRS: 0-3: slightly, 4-6: moderate, 7-10:
Yanagisawa M (2019) Long-term (10-year) ecacy of nasteride in 523 Japanese men with androgenetic alopecia
Volume 5: 2-5
Clin Res Trials, 2019 doi: 10.15761/CRT.1000273
A
. B.
C
. D.
E
. F.
G
. H.
I. J.
K
.
Figure 2. Scalp photographs at the rst visit and yearly, were evaluated about MGPA and N-H
A: At rst visit
B: At 1 year of treatment
C: At 2 years of treatment
D: At 3 years of treatment
E: At 4 years of treatment
F: At 5 years of treatment
G: At 6 years of treatment
H: At 7 years of treatment
I: At 9 years of treatment
K: At 10 years of treatment
Figure 1. The modied global photographic assessment score (MGPA): the standardized
7-point rating score using scalp photographs: 1, signicant disease progression; 2, moderate
disease progression; 3, slight disease progression; 4, no change; 5, slight improvement; 6,
moderate improvement; and 7, signicant improvement.
Scalp photographs of representative patient's for evaluation of MGPA.
Vertex photographs and (or) forehead photographs were taken for every patient at each
examination and used for evaluation.
A: Base line (MGPA=4) (Vertex photograph at rst visit)
B: Base line (MGPA=4) (Forehead photograph at rst visit)
C: MGPA=5 (Vertex photograph at 6 months of treatment)
D: MGPA=5 (Forehead photograph at 6 months of treatment)
E: MGPA=6 (Vertex photograph at 24 months of treatment)
F: MGPA=6 (Forehead photograph at 24 months of treatment)
G: MGPA=7 (Vertex photograph at 60 months of treatment)
H: MGPA=7 (Forehead photograph at 60 months of treatment)
(There is no display about cases of MGPA: 1/2/3)
A. B.
C. D.
E
. F.
G
. H.
signicant) [15,16] (Figure 3). Questionnaire items were as follows.
Q1: To what degree are you satised with your treatment? Q2: To what
degree do you feel your hair has improved? Q3: To what degree do
you wish to continue treatment? Q4: How would you compare your
hair loss to the hair of people of the same age pre-treatment? Q5: How
would you compare your hair loss to the hair of people of the same
age 10 years post-treatment? Numerical variables of the results are
presented as summary statistics (mean ± standard deviation); the data
were analyzed using Welch’s t-test for the ecacy evaluation. Statistical
analyses were performed using Microso Excel Statistics program
version 2.14; a P<0.05 was considered statistically signicant.
Safety Evaluation
Adverse reactions were recorded to evaluate safety by questionnaire.
Results
Patient Characteristics
e characteristics of all patients evaluated for AGA treatment
efficacy were as follows: age at rst visit, 37.8 ± 10.0 years; age range,
20–69 years; and values of each N-H at the rst visit: I/II/III/IV/V/VI/
VII, 6/116/204/124/61/18/3, respectively.
Yanagisawa M (2019) Long-term (10-year) ecacy of nasteride in 523 Japanese men with androgenetic alopecia
Volume 5: 3-5
Clin Res Trials, 2019 doi: 10.15761/CRT.1000273
Ecacy Evaluation in 10 years treatment
Objective ecacy - Scalp photographs
e proportions of patients with improvement (MGPA ≥ 5) or
prevention of disease progression (MGPA ≥ 4) at treatment year 10
were 91.5% (487/532) and 99.1% (527/532), respectively. e ecacy
evaluation showed that the MGPA improved significantly from year
1 through to year 10 of treatment compared with the baseline (MGPA
= 4). e MGPA of each N-H group was linear according to the N-H
number; the total was between N-H:III and N-H:IV (Figure 4 and
Table 1). Receiver operating characteristic curve (ROC) analysis was
performed to classify patients with improvement (MGPA ≥ 5) and
deteriorating (MGPA<5) condition at year 10 of treatment; the cut-o
point was N-H: III. (the area under the curve [AUC], which indicates
the predictive value, was 0.746.). Furthermore, the MGPA of the total
study population and the N-H:I/II/III group at the rst visit improved
from year 5 through to year 10, with statistically signicant dierences
(P<0.001). e early stage AGA group (N-H: I/II/III at rst visit)
showed more improvement with long-term AGA treatment (10-year)
with nasteride than the other groups did in the objective evaluation.
e N-H classication of AGA patients improved by approximately 1
grade over the 10-year treatment with nasteride; significant dierences
were observed from pre-treatment (3.35 ± 1.11) to post-treatment (2.55
± 1.30, P<0.001) in comparison of digitized classication.
Subjective evaluation - Questionnaire
e high subjective ecacy of AGA treatment was revealed
by the answers to Q1, “To what degree are you satised with your
treatment?” (7.09 ± 1.78); Q2, “To what degree do you feel your hair
has improved?” (6.95 ± 1.82), and Q3, “To what degree do you wish to
continue treatment?” (8.26 ± 1.84).
A signicant dierence was observed between Q4 and Q5 (pre- and
10-year post-treatment, 3.41 ± 2.12 and 4.93 ± 2.21, respectively, P <
0.001) (Table 2). Furthermore, a comparison between the N-H: I/II/
III and N-H:IV/V/VI/VII groups at rst visit revealed a statistically
signicant dierence in the answer to Q 1, 2, 4, and 5 (P<0.001) and
Q3 (P<0.05). e early stage AGA group (N-H: I/II/III at rst visit) also
showed a greater improvement following long-term (10-year) treatment
with nasteride than the other groups did in the subjective evaluation.
Safety Evaluation
During the study period for 10 years, no serious adverse reaction
was recognized. Mild and temporary adverse reactions were recorded
in 6.8% (36⁄532) of the entire study population by questionnaire. e
adverse reactions were decreased libido (5.6%, n=30) and erectile
dysfunction (3.0%, n=16). All adverse reactions were mild and all
patients continued treatment for 10 years.
Discussion
Ecacy Evaluation
Objective evaluation - Scalp photographs
We evaluated the long-term (10-year) ecacy and safety of AGA
treatment with 1 mg/day nasteride in a large study population (532
patients), as the rst study of this kind in Japan, to our knowledge. A
high objective ecacy was demonstrated by the MGPA, which revealed
improvement and prevention of disease progression in 99.1% of the 532
Japanese men with AGA treated with 1 mg/day nasteride for 10 years.
Furthermore, the outcome was similar to or better than that reported
N-H Number 0Y 1Y 2Y 3Y 4Y
I6 4.00 5.33 ± 0.51 5.56 ± 0.50 5.72 ± 0.62 6.00 ± 0.64
II (a,v) 116 4.00 5.17 ± 0.61 5.59 ± 0.70 5.82 ± 0.72 5.99 ± 0.75
III (a,v) 204 4.00 5.21 ± 0.47 5.59 ±0.53 5.79 ± 0.55 5.95± 0.56
IV (a) 124 4.00 5.09 ± 0.42 5.38 ± 0.50 5.53 ± 0.57 5.62 ± 0.60
V (a) 16 4.00 5.02 ± 0.29 5.35 ± 0.41 5.38 ± 0.40 5.37 ± 0.46
VI 18 4.00 5.02 ± 0.36 4.98 ±0.38 5.00 ± 0.29 5.00 ± 0.27
VII 3 4.00 4.78 ± 0.31 5.00 ± 0.27 4.89± 0.29 4.89 ± 0.42
Total 532 4.00 5.14 ± 0.51 5.49 ± 0.59 5.66 ± 0.62 5.78 ± 0.66
5Y 6Y 7Y 8Y 9Y 10Y
6.22 ± 0.53 6.39 ± 0.53 6.39 ± 0.64 6.50 ± 0.63 6.61 ± 0.49 6.50 ± 0.57
6.13 ± 0.67 6.20 ± 0.67 6.20 ± 0.65 6.29 ± 0.67 6.27 ± 0.70 6.33 ± 0.66
6.09 ± 0.58 6.13 ± 0.58 6.13 ± 0.59 6.20 ± 0.61 6.21 ± 0.60 6.22 ± 0.59
5.74 ± 0.62 5.75 ± 0.62 5.75 ± 0.73 5.74 ± 0.73 5.74 ± 0.74 5.72 ± 0.79
5.38 ± 0.53 5.34 ± 0.53 5.34 ± 0.58 5.33± 0.64 5.28 ± 0.68 5.34 ± 0.61
4.96 ± 0.47 4.87± 0.47 4.87 ± 0.49 4.89 ± 0.58 4.89 ± 0.66 4.87 ± 0.64
4.78 ± 0.31 4.78 ± 0.31 4.78 ± 0.42 4.67 ± 0.27 4.67 ± 0.27 4.67 ± 0.27
5.89 ± 0.68 5.92 ± 0.72 5.92 ± 0.72 5.96 ± 0.77 5.96 ± 0.78 5.96 ± 0.78
Mean ± Standard Deviation (Mean ± SD) *, there were signicant dierences in MGPA at
year 10 between N-H:I/II/III and N-H:IV/V/VI/VII groups (P<0.001)
Table 1. Changes in modied global photographic assessment scores (MGPA) from before
treatment through to year 10 in each Norwood-Hamilton scale (N-H) group at rst visit
Q1 7.09 ± 1.78
Q2 6.95 ± 1.82
Q3 8.26 ± 1.84
Q4 3.41 ± 2.12
Q5 4.93 ± 2.21
Table 2. Numerical analysis of answers to questionnaire using numerical rating scale (NRS)
Mean ± SD *
Q1: To what degree are you satised with your treatment?
Q2: To what degree do you feel your hair has improved?
Q3: To what degree do you wish to continue treatment?
Q4: How would you compare your hair loss to the hair of people of the same age pre-treatment?
Q5: How would you compare your hair loss to the hair of people of the same age 10 years
post-treatment?
Figure 3. Numerical Rating Scale (NRS): entry example. NRS: the standardized 11-point
rating was scored by patients themselves, 0-3: slightly, 4-6: moderate, 7-10: signicant
Figure 4. Changes in modied global photographic assessment scores (MGPA) from
before treatment through year 10 of treatment on each Norwood-Hamilton scale (N-H)
group at rst visit.
Yanagisawa M (2019) Long-term (10-year) ecacy of nasteride in 523 Japanese men with androgenetic alopecia
Volume 5: 4-5
Clin Res Trials, 2019 doi: 10.15761/CRT.1000273
by other studies in Japan [8-10,13,17]. Dierences have been known
to occur in the progression of AGA symptoms between Japanese and
Caucasian men [8,18]. is ecacy of the investigated treatment in
Japanese men exceeded that reported in other studies in Caucasians.
e superior response of Japanese men with AGA was reported to
likely be attributable to their hair characteristics (greater diameter,
black color, and lower density), which facilitated the detection of slight
changes [10,19-23]. A novel nding observed in this study was the
signicant dierence in the improvement of AGA following nasteride
treatment between the N-H: I/II/III and N-H: IV/V/VI/VII groups
at the rst visit. e ROC analysis revealed a similar dierence, that
was performed to classify patients with improvement (MGPA≥5) and
deteriorating (MGPA<5) condition at year 10 of treatment; the cut-o
point was N-H: III (AUC: 0.746). Furthermore, the MGPA of the total
study population and the N-H: I/II/III group at the rst visit signicantly
improved from treatment year 5 to 10 (P<0.001). is ecacy was
dierent from that of a 5-year study in Japanese men, which reported
that the ecacy began to plateau aer 4 years of treatment [10]. Several
studies have reported that AGA progresses in N-H classication with
age, [7,11,12,18] and that younger patients show more improvement
than that of older patients with AGA treatment [24,25]. In this study,
AGA patients at the early stage of N-H classication showed more
improvement than patients at the later stage did.
Subjective evaluation - Questionnaire
Several studies using questionnaires on AGA administered to
patients and doctors have been reported [26-28]. We evaluated the
questionnaires administered to patients with AGA who were treated
with nasteride for 10 years. A highly subjective ecacy was revealed
by all answers to the questionnaires. Especially, the analysis showed
that the score of the response to Q3; “To what degree do you wish to
continue treatment?” was high (8.26 ± 1.84), which could be attributed
to the fact that the patients had undergone the treatment for 10 years
already. However, the subjective ecacy of long-term treatment of
AGA with nasteride was evident based on the dierences in the results
between Q4 and Q5 (pre- and post-treatment, 3.41 ± 2.12 and 4.93 ±
2.21, respectively, P<0.001). A high ecacy and signicant dierence
in improvement of AGA with nasteride treatment was also observed
between the N-H: I/II/III and N-H: IV/V/VI/VII groups at rst visit in
the objective evaluation using the questionnaire.
Safety evaluation
Adverse reactions were recorded in 6.8% (36/532) in the safety
evaluation in this study, which was slightly higher than that observed in
other studies in Japanese men [8,9,17]. is observation was thought to
have been caused by the fact that the investigation period of this study
was longer than that of others and, therefore, the patients had aged
more. Incidences of decreased libido and erectile dysfunction have
been known to increase in proportion with age. In the investigation
in 40 years or older of Asians, the incidences of decreased libido and
erectile dysfunction were 6.0–38.7% and 40.6–70.0%, respectively
[29,23]. Overall, the adverse reactions were all mild, and the incidence
was lower than the generic incidence of decreased libido and erectile
dysfunction in Asians. As adverse reactions were recorded by patients
in a subjective questionnaire, the result was thought to be slightly
dierent from the correct number of adverse reactions in this study.
Strict safety evaluation was not investigated in this study. Several
studies on AGA treatment with nasteride have reported that there
are no signicant dierences from the placebo in adverse reactions,
[13,30,31] and that the risk of discontinuing the treatment because of
adverse reaction is similar to that of the placebo [32].
In summary, long–term (10-year) AGA treatment with nasteride
1 mg/day demonstrated a high ecacy and safety based on subjective
and objective evaluations in Japanese men. Specically, the N-H
classication of AGA patients improved by approximately 1 grade aer
10 years of treatment with nasteride. Furthermore, a novel discovery
of this study was that the group with N-H:I/II/III at the rst visit
showed greater improvement than the group with N-H: IV/V/ VI/VII
at rst visit, following 10 years of AGA treatment with nasteride. We
recommend that AGA patients should start treatment with 1 mg/day
nasteride at the early stage of classication of AGA (within N-H: I, II,
or III) for adequate ecacy.
Acknowledgments
We would like to thank the stas and residents of our departments.
Conict of interest statement
e authors state no conict of interests
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Volume 5: 5-5
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... 32 The long-term safety of finasteride, over a period of 10 years has been documented in studies. 33,34 Recent reports about postfinasteride syndrome have created a fear among patients seeking treatment. While low quality studies neither confirm nor refute postfinasteride syndrome as a valid nosologic entity, it would be just as inappropriate to dismiss it as nonexistent. ...
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Androgenetic alopecia (AGA) is a multi‐factorial disease that carries a significant psychological burden with it. Dihydrotestosterone, the main pathogenic androgen in AGA, is produced by conversion of testosterone, which is catalyzed by the 5‐alpha reductase (5‐AR) isoenzyme family. Finasteride and dutasteride are inhibitors of these enzymes. Finasteride, which is a single receptor 5‐alpha reductase inhibitor (5‐ARI), acts by blocking dihydrotestosterone (DHT). Dutasteride, a dual receptor DHT blocker, has a higher potency than its predecessor, finasteride. This review corroborates the evidence of superiority of dutasteride over finasteride, and its comparable safety profile concerning fertility, teratogenicity, neurotoxicity, and hepatotoxicity. This article is protected by copyright. All rights reserved.
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Background: Oral finasteride is an FDA-approved treatment for androgenetic alopecia (AGA). Topical finasteride, while not FDA-approved, lacks the systemic adverse effects associated with oral finasteride. The efficacy of topical finasteride has been evaluated. Aim: To review whether topical finasteride is a safe and effective treatment for male and female pattern hair loss. Method: A structured search in PubMed and Google Scholar identified 864 records, with 32 articles meeting the inclusion criteria for review. Results and discussion: In a phase III, randomized, controlled trial, the efficacies of topical 0.25% w/w finasteride spray (1-4 sprays; 50-200 μl/day) and once-daily finasteride 1 mg oral tablet were similar when administered for 24 weeks (mean change from baseline, 20.2 vs. 21.1 hairs/cm2 ). Additionally, a double-blind, randomized trial compared the efficacies of twice-daily finasteride 1% topical gel and once-daily finasteride 1 mg oral tablet for 6 months, and found similar results in both groups. Moreover, a combination of topical minoxidil and topical finasteride may enhance efficacy. Topical finasteride reduces both scalp and plasma DHT levels. In an open-label pharmacodynamic study, a 7-day treatment of twice-daily finasteride 0.25% topical solution and once-daily finasteride 1 mg oral tablet provided similar inhibition of plasma DHT. Topical finasteride reduces the potential for systemic side effects, including the risk of sexual dysfunction. The side effects are localized to the application site, for example, scalp pruritus, burning sensation, irritation, contact dermatitis, and erythema. Conclusion: Topical finasteride may be an alternative for those concerned about the oral formulation's systemic side effects.
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Background: Dihydrotestosterone (DHT), the most critical pathogenic androgen in hair loss, is identified as an etiologic factor of androgenetic alopecia (AGA). The AGA is a genetically common disorder among men and is characterized by the progressive conversion of hair follicles into small vellus hair. Steroid 5 alpha-reductase type 1 (5AR1) is a crucial target responsible for this gradual replacement. The 5AR1 function is determined by converting testosterone to DHT. The inhibitors of 5AR1 play their role by blocking the DHT production pathway. Objectives: This study focused on the potent inhibitors of the 5AR1 enzyme to suggest effective synthetic drugs for restoring hair loss with fewer side effects. Methods: The three-dimensional structure of 5AR1 was created using homology modeling methods. Then, the inhibitory effects of some significant compounds from natural sources were examined on the 5AR1 protein using molecular docking approaches. Results: The obtained results suggest that two natural compounds isolated from Serenoa repens, including beta-sitosterol and stigmasterol, could inhibit the regular activity of 5AR1 and can be recommended as safe and novel AGA medicines for hair restoration.
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Background: Dihydrotestosterone (DHT), the most critical pathogenic androgen in hair loss, is identified as an etiologic factor of androgenetic alopecia (AGA). The AGA is a genetically common disorder among men and is characterized by the progressive conversion of hair follicles into small vellus hair. Steroid 5 alpha-reductase type 1 (5AR1) is a crucial target responsible for this gradual replacement. The 5AR1 function is determined by converting testosterone to DHT. The inhibitors of 5AR1 play their role by blocking the DHT production pathway. Objectives: This study focused on the potent inhibitors of the 5AR1 enzyme to suggest effective synthetic drugs for restoring hair loss with fewer side effects. Methods: The three-dimensional structure of 5AR1 was created using homology modeling methods. Then, the inhibitory effects of some significant compounds from natural sources were examined on the 5AR1 protein using molecular docking approaches. Results: The obtained results suggest that two natural compounds isolated from Serenoa repens, including beta-sitosterol and stigmasterol, could inhibit the regular activity of 5AR1 and can be recommended as safe and novel AGA medicines for hair restoration.
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Background: Oral 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. Objectives: To evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride. Methods: This randomised, 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. Results: Of 458 randomised 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 considered 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 versus oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride. Conclusion: Topical 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.
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Androgenetic alopecia (AGA) is the most common type of hair loss and affects both men and women. Male pattern hair loss shows characteristic frontal recession and vertex baldness, whereas female pattern hair loss produces diffuse alopecia over the mid-frontal scalp. AGA is mediated by increased androgen susceptibility in affected scalp hairs. 5α-Reductase converts testosterone into dihydrotestosterone, a potent androgen, in the scalp. Both androgen receptors and 5α-reductase have higher expression levels in the balding scalp than in non-affected regions. Increased androgen susceptibility induces hair follicle miniaturization, which leads to the progressive loss of thicker terminal hairs in the balding scalp. Currently, topical minoxidil and oral 5α-reductase inhibitors, such as finasteride and dutasteride, are approved options for the pharmacological treatment of AGA. Topical minoxidil remains the mainstay of therapy for mild to moderate AGA in both men and women. The daily intake of 1-mg finasteride or 0.5-mg dutasteride shows better efficacy than topical minoxidil in regard to hair regrowth in male AGA. Anti-androgens can be used in female AGA wit clinical and biochemical evidence of hyperandrogenism. Patients may be overwhelmed and confused by the variety of treatment options for AGA management, including over-the-count drugs with low evidence quality. Therefore, physicians must be aware of the current guidelines for the management of AGA based on evidence-based approaches to select better options for patients.
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Introduction: Treatment with finasteride 1 mg/day represents the therapy of choice for androgenetic alopecia (AGA). We investigated how Italian dermatologists approach use of finasteride for treatment of AGA and common side effects reported by patients. Methods: A tablet-based survey was conducted from February 2017 to January 2018 in Italy to investigating use of 1 mg/day finasteride in the treatment of AGA. Approximately 1153 Italian dermatologists were surveyed about prescription frequency, therapy duration, treatment practices, and side effects eventually reported. Results: Dermatologists considered treatment with 1 mg/day finasteride to be the most efficacious treatment for AGA, as reflecting by its long-term (5 years) prescription. Data on sexual side effects from our survey are in line with previous scientific evidence, especially regarding loss of libido, erectile dysfunction, and problems with ejaculation, but also in the psychological sphere and regarding physical impairments such as myalgia and loss of muscle tone. Conclusions: This is the first preliminary observational study on how Italian dermatologists approach use of finasteride to treat AGA. Although side effects have been reported, especially in the sexual sphere, lack of alternative treatments with the same efficacy leads dermatologists to prescribe 1 mg/day finasteride with a tendency to prolong therapy in the long term. Funding: Giuliani S.p.A.
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This survey aimed to explore patient and physician attitudes towards male androgenetic alopecia (AGA), satisfaction with currently available male AGA treatments and investigate the factors affecting treatment choice. The survey was carried out in five countries (Japan, South Korea, Taiwan, Mexico and Brazil) between November and December 2015 using a standard market research methodology. Questionnaires were completed by patients with male AGA or hair loss/thinning and practicing physicians who were responsible for prescribing AGA treatment. In total, 835 patients and 338 physicians completed the questionnaire. Overall, 37.6% of patients reported satisfaction with the treatments they had used. The highest patient satisfaction was reported for 5-alpha-reductase inhibitors (53.9% of patients satisfied). In all countries, physicians were more likely than patients to think that male AGA has a major impact on patient confidence (89.3% vs 70.4%, respectively). There was agreement by physicians and patients that male AGA patients who are involved in their treatment decisions have better outcomes. Patients who were satisfied with AGA treatments were more likely to have the level of involvement they desired in treatment decisions (69.1% of satisfied patients) than dissatisfied patients (56.4% of dissatisfied patients). This survey provides valuable insights into the attitudes of patients and physicians in Asia and Latin America about male AGA and its treatments. The survey identified areas of disconnect between physicians and patients regarding the impact of male AGA, treatment consultations and the importance of treatment attributes. It also highlights the need for physicians to spend sufficient time with patients discussing AGA treatment approaches.
Chapter
Hamilton (1951), in a frontier work, extensively studied the developing patterns of scalp hair in men and women from the prenatal period through the tenth decade. He divided the balding patterns into eight types with three sub-divisions, then compared the incidence of baldness between Caucasian and Chinese.
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Finasteride is standard medical treatment for androgenetic alopecia; however, no large studies with 5 years or more of follow up have been performed in Japan. The authors followed Japanese men with androgenetic alopecia treated with finasteride for 5 years to evaluate long-term treatment efficacy. Of 903 men treated with finasteride (1 mg/day), 801 patients were evaluated over 5 years by modified global photographic assessment. Although the proportion of improvement was high (99.4%), modified global photographic assessment scores after 5 years of treatment were lower in patients with more advanced disease as measured by the modified Norwood-Hamilton scale. After separating patients into "sufficient" and "insufficient" efficacy groups according to the modified global photographic assessment score after 5 years (scores ≥6 and <6, respectively), multivariate analysis showed that independent risk factors of insufficient efficacy were age at start of treatment of 40 years or more (P = 0.021) and classification on the modified Norwood-Hamilton scale (P < 0.001), whereas presence of stress at start of treatment was a negative predictor (P = 0.025). In conclusion, continuous finasteride treatment for 5 years improved androgenetic alopecia with sustained effect among Japanese. Younger age and less advanced disease at start of treatment were the key predictors of higher finasteride efficacy. © 2015 Japanese Dermatological Association.
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A large percentage of men are still sexually active as they age. Hence, sexual problems potentially impair men’s quality of life even in later years. Erectile dysfunction, premature ejaculation and hypogonadism are among the common sexual health problems faced by men. Published data from Asian countries demonstrate that erectile dysfunction is associated with poor quality of life in the mental and vitality domains, with increased physical co-morbidity, such as diabetes, heart diseases, prostate hyperplasia, and hyperlipidemia, and with psychological ill-health e.g. depression. A great proportion of men are also bothered by their erectile dysfunction. Although the data on premature ejaculation and hypogonadism in Asian countries are limited, there is evidence to suggest that premature ejaculation is associated with perceived low general health status, increased depression, increased anxiety, and poor mental health and vitality scores. The data also suggests that hypogonadism is associated with a number of domains in quality of life scores and depression. In conclusion, in Asian countries, erectile dysfunction, premature ejaculation and hypogonadism should be actively identified and treated to improve men’s quality of life.
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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.