REVIEW

URRENT
C
OPINION

5a-Reductase inhibitors in androgenetic alopecia

Elizabeth Yim, Katherine L. Baquerizo Nole, and Antonella Tosti

Purpose of review
The authors will review the current literature on efficacy and safety of 5-alpha reductase inhibitors (5aRIs)
for androgenetic alopecia (AGA).
Recent findings
The 5aRI finasteride and dutasteride are effective in treating AGA and promoting hair regrowth. 5aRI can
be given orally, topically and more recently through mesotherapy. However, there has been an increasing
concern about permanent sexual adverse events such as impotence and infertility. Most of these reports are
published as case reports, and two studies reporting persistent sexual side-effects after discontinuation of
finasteride had serious method limitations, as patients were recruited from a website. To our knowledge,
permanent sexual adverse events have yet to be published in higher quality studies, such as randomized
controlled trials. Although patients treated with 5aRIs have an increased incidence of sexual adverse
events, these events decrease if discontinued or over time with continued therapy.
Summary
Sexual side-effects are uncommon and resolve spontaneously in most patients even without discontinuing
therapy. Significant effort is underway to find delivery systems that optimize delivery and reduce systemic
absorption of topical 5aRs including hydroxypropyl chitosan and liposomal and nanoparticulate systems.
Keywords
5a-reductase, 5a-reductase inhibitor, androgenetic alopecia, dutasteride, finasteride

INTRODUCTION
Androgenetic alopecia (AGA) is the most common
form of hair loss and occurs in both men and
women. The prevalence is highest in whites, reaching 80% in men over the age of 70 [1]. In AGA,
5a-reductase (5aR) enzymes convert testosterone to
dihydrotestosterone (DHT), a potent metabolite of
testosterone. DHT binds to androgen receptors with
a five-fold greater affinity than testosterone, activating genes responsible for the gradual transformation
of large terminal follicles to small, miniaturized
follicles [2 ,3]. There are three isoforms of 5aR.
Type 1 is mainly present in sebaceous and sweat
glands in the skin. Type 2 predominates in the
genital skin, beard, prostate and scalp hair follicles
[4]. Type 3 is found throughout the epidermis and
dermis, and in higher concentrations than types 1
and 2 in the dermis [5].
Currently, oral finasteride, a type 2 5a-reductase
inhibitor (5aRI), is approved for the treatment of
AGA in men in the USA, Canada, Europe, South
America and Asia. Dutasteride is a dual type 1 and 2
5aRI that is US Foods and Drug Administration
(FDA) approved only for benign prostatic hyperplasia (BPH) treatment. It is approved for treatment of
&&

AGA in Korea and has been used off-label worldwide.

In the last few years, there has been a rising
concern about severe and possibly long-lasting sideeffects of these medications, including persistent
erectile dysfunction, infertility and depression.
The authors will discuss the literature of the role
of 5aRIs in treating AGA, and their side-effects.
A MEDLINE and PubMed search was done in
March 2014 to identify clinical studies and case
reports regarding efficacy and tolerability of finasteride and dutasteride in AGA. The keywords were
finasteride, dutasteride, topical finasteride,
5-alpha reductase inhibitors, androgenetic alopecia, 3-oxo-5-alpha-steroid 4-dehydrogenase Inhibitor, male pattern baldness and female pattern
Department of Dermatology and Cutaneous Surgery, University of Miami
Miller School of Medicine, Miami, Florida, USA
Correspondence to Antonella Tosti, MD, University of Miami Leonard M.
Miller School of Medicine, 1600 NW 10th Ave. RMSB, Room 2023-A,
Miami, FL 33136, USA. Tel: +1 305 243 8205; fax: +1 305 689 2211;
e-mail: ATosti@med.miami.edu
Curr Opin Endocrinol Diabetes Obes 2014, 21:493498
DOI:10.1097/MED.0000000000000112

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Reproductive endocrinology

KEY POINTS

5aRIs, such as finasteride and dutasteride, are a well
tolerated and effective treatment for AGA. They can be
delivered orally, topically or through mesotherapy.

However, patients should be informed of such sideeffects such as decreased libido, decreased ejaculatory
volume and increased risk for developing
gynecomastia, prostate cancer and depression.

Sexual side-effects are uncommon and resolve
spontaneously in most patients even without
discontinuing therapy.

baldness. We also reviewed the drug package inserts

and postmarketing data. We also searched the references of selected studies to identify studies not
retrieved in the initial search (the snowball method).

FINASTERIDE
Finasteride is a 5aRI that binds irreversibly to 5aR
and has a half-life of 68 h [6]. It is a potent inhibitor
of 5aR type 2 and type 3, and a weak inhibitor of 5aR
type I [4]. It has been reported to improve male
pattern hair loss within 3 months [7]. Intake of
finasteride has led to a significant reduction of scalp
and serum DHT [8], increases in hair counts and
improvements in patient and investigator assessments of hair appearance [9,1012]. In addition,
significant increases in serum testosterone levels
have been observed in patients treated after 12
and 24 months [13,14]. Long-term efficacy studies
have shown increased hair counts at 24 [12] and
48 months [10,11]. Individuals on finasteride have
maintained their hair weight up to 4 years, whereas
individuals not taking finasteride experienced progressive decrease in hair weight [10]. Improvement
in quality of life has also been reported with finasteride [15].
Finasteride is most effective on the vertex, and
less in the fronto-temporal areas of the scalp. In
younger men, finasteride may help reduce hair
loss in all areas of the scalp compared with older
men [16,17]. Finasteride may be more effective in
individuals who have a higher density of body hair
than those who did not [18 ], as well as in individuals who improved in the first year [19]. In a 10-year
follow-up study, only 32% of individuals who were
unchanged or worsened in the first year had an
improvement at 10 years [19]. This suggests that
patients who show no improvement at 12 months
are less likely to show an improvement with longterm use of finasteride.
Efficacy of oral finasteride in the treatment of
female pattern hair loss (FPHL) is controversial. A
&

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randomized controlled trial (RCT) did not show a

difference between finasteride 1 mg daily vs. placebo
in postmenopausal women [20]. However, this dosage may be insufficient for women and a recent trial
showed improvement in hair density and thickness
in 87 normoandrogenic FPHL patients after 1-year
follow-up on 5 mg [21].

TOPICAL FINASTERIDE
For patients who are concerned about systemic sideeffects of 5aRI, an alternative is topical administration [22]. Sitticharoenchai [23] demonstrated
that finasteride 0.5% lotion increased hair count
and improved photographic assessment at 6 months
in 50 men. A double-blind RCT (n 38) showed
that finasteride 1% gel was equally as effective as
finasteride 1 mg in increasing total hair count after
6 months of treatment [24].

FINASTERIDE VS. MINOXIDIL

In addition, there is evidence that finasteride 1 mg
is superior to minoxidil 2% [25,26], but not to
minoxidil 5% [27]. In addition, combined therapy
with oral finasteride and topical minoxidil is more
effective than monotherapy [25,28]. However, finasteride may not prevent telogen effluvium with worsening of AGA after discontinuing minoxidil [29].
This may be attributed to different mechanisms of
action of the two medications.

DUTASTERIDE
Oral dutasteride 0.5 mg daily is generally well
tolerated with a low incidence of sexual sideeffects [30]. It is three times and 100 times more
potent than finasteride in inhibiting type 2 5aR
and type 1 5aR, respectively [31,32]. Dutasteride
has an extremely long half-life (45 weeks) [33].
Dutasteride 0.5 mg daily has been shown to significantly increase hair counts and have a higher
efficacy by individual self-assessment and photographic assessment when compared with placebo
[34].
A meta-analysis of studies comparing dutasteride 0.5 mg to finasteride 1 and 5 mg demonstrated
similar efficacy outcomes, measured with global
photographic assessment, patient self-assessment
and hair counts [35 ]. However, a higher dose of
dutasteride 2.5 mg had a superior efficacy to finasteride 5 mg in treating AGA, with a reduction in
serum DHT by 92 vs. 73% by finasteride [4,32]. Scalp
DHT decreased by 79 and 51% with 2.5 and 0.5 mg
of dutasteride, respectively, compared with 41%
with 5 mg of finasteride.
&&

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5a-reductase inhibitors in androgenetic alopecia Yim et al.

Not included in this meta-analysis was an RCT

(n 917 men) that was published in 2014 comparing dutasteride at 0.02, 0.1 or 0.5 mg daily, finasteride 1 mg daily and placebo. At 24 weeks, dutasteride
0.5 mg had significantly higher hair count and
width, and improved hair growth compared with
finasteride and placebo [36 ].
There are no studies investigating the effect of
dutasteride combined with minoxidil. There is only
one case report using dutasteride 0.5 mg as an adjuvant to finasteride after the initial response to finasteride declined [37 ]. After 3 months, they observed
a dramatic increase in hair density.
&&

&&

TOPICAL DUTASTERIDE
We found only one study investigating the use of
topical dutasteride. A small trial (n 15) used a
formulation containing dutasteride, finasteride
and minoxidil at unknown concentrations (trade
secret). Patients were given the option of adding
minoxidil foam 5%, ketoconazole 2% shampoo
and/or finasteride 1 mg daily. Although all patients
demonstrated significant hair regrowth by photographic assessment, these effects were observed earlier in patients using all four components [38]. The
small sample size, the undisclosed formulation and
the addition of other therapeutic options make
interpretation of these results difficult.
More recently, dutasteride has been used as an
agent in mesotherapy [39], a technique involving
microinjection of medication and/or vitamins,
which has recently attracted attention as a treatment for several cosmetic indications, including
hair loss. Despite the amount of publicity, scientific
data about its efficacy are scarce. The largest trial in
men (n 90) compared dutasteride (0.005%) alone,
dutasteride-containing solution (dutasteride 0.05%
along with dexapanthenol, biotin and pyridoxine)
and a 0.9% saline control. There was a significant
increase of anagen hair, anagentelogen ratio and
mean hair shaft diameter in the group with dutasteride-containing solution. This difference could
be explained by differences in the concentration
or by the addition of hair growth promoters
[40 ]. A double-blind trial on 126 women compared
mesotherapy with a dutasteride-containing solution
(dutasteride 0.025%, along with dexapanthenol,
biotin, pyridoxine), and a saline control. They
found that 62.8% of dutasteride-treated patients
improved at the end of 18 weeks vs. 17.5% of controls, with no difference in side-effects, which were
minimal [2 ].
&&

&&

SIDE-EFFECTS
The safety and tolerability of 5aRIs have been documented through many clinical trials for treating

AGA and BPH [8,13,16,41,42]. However, side-effects

may occur and long-term safety of 5aRIs needs to
be discussed.

SEXUAL SIDE-EFFECTS
In the last few years, the media has largely covered
the risk of nonreversible sexual side-effects due to
5aRIs. Published RCTs have shown that drug-related
sexual adverse experiences, including decreased
libido, erectile dysfunction and decreased ejaculate
volume, were higher in treated groups, but the
overall incidences were generally low and did not
necessarily require discontinuation of treatment
[9,10,16,19]. These side-effects were always reported
reversible upon cessation of the medication or on
continued treatment. In one study, the incidence of
sexual dysfunction was not significantly different
from the placebo group [7]. However, a systematic
review of nine trials showed that finasteride therapy
had an increased risk of sexual disturbances, including erectile dysfunction, decreased libido, ejaculation dysfunction and withdrawals because of sexual
adverse events, but all were not found to be significant (P 0.85, P 0.41, P 0.60, P 0.55, P 0.38,
respectively) [12]. Sexual side-effects can depend on
increased oestrogen levels due to the metabolization
of testosterone through the aromatase enzymes or
to a reduction of DHT in the brain.
Although not reported in RCTs, there have been
reports of sperm DNA damage [43,44]. However,
most patients had other conditions contributing
to infertility, such as a varicocele [45,46], and
obesity [46], which finasteride may amplify
[47,48]. The largest study that randomized 99
men with normal semen parameters to receive
dutasteride 0.5 mg, finasteride 5 mg or placebo for
1 year found that only finasteride 5 mg had a mild
effect on spermatogenesis. There were also two studies reporting persistent sexual side-effects after discontinuation of finasteride, but had serious method
limitations as patients were recruited from a website,
Propeciahelp.com, and serum hormone levels were
not evaluated [47,48]. Therefore, further data are
needed to validate the reported cases of persistent
sexual side-effects.
A meta-analysis comparing safety of dutasteride
0.5 mg and finasteride 1 and 5 mg revealed that the
treatment groups did not significantly differ from
placebo in eliciting sexual dysfunction [35 ].
Higher doses of dutasteride, such as 2.5 mg daily,
had an increase in sexual adverse events compared
with 0.5 mg dutasteride and 5 mg finasteride [32].
However, the incidence of sexual adverse events
decreased over time with continued therapy, or if
discontinued. Side-effects were mild or moderate in
severity. There were no reports on fertility effects.

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Because of its long half-life, dutasteride causes persistent suppression of DHT levels after discontinuation [32].

GYNECOMASTIA AND BREAST CANCER

There have been several reports of gynecomastia
linked to finasteride [49,50]. Thompson et al. [51]
reported 4.5% incidence of gynecomastia in individuals receiving 5 mg finasteride vs. 2.8% of those
receiving placebo. Two RCT studies testing 0.5 mg
dutasteride for BPH and prostate cancer reported an
incidence rate of gynecomastia of 1.9 [52] and 1.8%
[53], respectively. In patients taking 1 mg finasteride
for AGA, Rossi et al. [19] reported no cases of gynecomastia in a 10-year follow-up of 118 patients.
Only one patient out of 184 patients receiving
0.5 mg dutasteride in an RCT reported gynecomastia
[36 ].
Another important concern is a possible link
between finasteride and breast cancer. Between
1992 and 2009, there were 50 worldwide case reports
of male breast cancer with 5 mg and three cases with
1 mg of finasteride [54]. On the basis of these reports,
the UKs Medicines and Healthcare Products Regulatory Agency, which parallels the role of the FDA,
published a warning in 2009 regarding finasteride
and potential risk of male breast cancer [54]. However, a recent study found no association between
breast cancer and finasteride exposure of 13 year
time frames when comparing 339 male breast cancer
cases matched to 6780 controls [55].
&&

DEPRESSION
Although there are reports of depression during
finasteride treatment [43,5658], this side-effect
has not been documented in clinical trials of finasteride for AGA [8]. Mechanisms underlying this
possible side-effect are unclear, but it has been
postulated that depression may be due to reduction
of 5aR activity in the brain, wherein the enzymes are
found in neurons, oligodendrocytes and astrocytes.

PROSTATE CANCER
The Prostate Cancer Prevention Trial, which
randomized 19 000 men to receive finasteride
5 mg daily or placebo, found that after 7 years,
finasteride prevented or delayed the appearance of
prostate cancer [51]. However, men on finasteride
were more likely to develop moderate and highgrade prostate cancers. The Dutasteride and Prostate
Cancer study produced similar results, showing a
reduced risk for low-grade prostate cancer, but an
increased number of high-grade Gleason score
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cancers in the treatment group compared with

placebo [52]. These results have been attributed to
enhanced detection of prostate cancer in patients on
finasteride. Thompson et al. [51] showed that the
sensitivity of PSA was higher for men in the finasteride group than in the placebo, which may explain
the detection of high-grade prostatic cancers. Recent
animal studies showed that mice treated with dutasteride had the greatest inhibition of prostatic intraepithelial neoplasia progression and prostate cancer
development [59].

TERATOGENICITY
Finasteride is contraindicated in child-bearing
women due to teratogenic effects on the male offspring. Inhibition of conversion of foetal testosterone to DHT could impair virilization of a male
foetus. It is recommended that men being treated
with dutasteride should not donate blood until at
least 6 months past their last dose to prevent administration to a pregnant female transfusion recipient.

TOPICAL FORMULATIONS
The most reported side-effects are mild erythema
[24] or contact dermatitis [60,61]. To our knowledge, no sexual side-effects have been reported in
humans with topical formulations. Although the
risks of a topical formulation are usually less than
those associated with systemic forms, topical finasteride can be absorbed and animal studies have
shown a decrease in prostatic weight and size of
sebaceous glands [62,63]. Finasteride 0.05% was
initially reported to reduce serum DHT by 30% after
4 weeks [64], but a subsequent larger investigation
was unable to duplicate these results [61].
Side-effects associated with mesotherapy with
dutasteride include mild pain, headache [39] and
pruritus [2 ]. Although not statistically significant,
a decline in semen volume, sperm concentration
and sperm motility has been reported, with recovery
months after discontinuing treatment [40 ]. No
significant decrease of DHT, libido or erectile or
ejaculatory function has been reported given the
small number of treated patients; however, more
data are needed before making a conclusion [40 ].
The technique itself can cause significant sideeffects and there are reports of patchy scarring
alopecia [65], scalp abscess and subcutaneous fat
necrosis [66].
&&

&&

&&

CONCLUSION
Our review shows that 5aRIs are a well tolerated and
effective treatment for AGA. Sexual side-effects are
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5a-reductase inhibitors in androgenetic alopecia Yim et al.

uncommon and resolve spontaneously in most

patients even without discontinuing therapy. Early
intervention is desirable, as treatment is more effective at arresting progression of hair loss than stimulating regrowth. When managing patients with
AGA, baseline photographs are helpful and should
be repeated every 6 months. Patients should be
educated about the pros and cons of treatment
and informed about possible side-effects. Long-term
studies using dutasteride in AGA patients are still
warranted. Significant effort is underway to find
delivery systems that optimize delivery and reduce
systemic absorption of topical 5aRs, including
hydroxypropyl chitosan and liposomal and nanoparticulate systems. Given the promising results of
systemic 5aRIs in AGA, we eagerly await the result of
future clinical trials.
Acknowledgements
There was no funding for this manuscript.
Conflicts of interest
There are no conflicts of interest.

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Volume 21
Number 6
December 2014

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