Article published online: 2021-12-13

THIEME
422 Review Article

Pharmacological Management of Pattern Hair Loss

Sandeep Suresh Sattur1 Indu Sandeep Sattur1

1 HAIRREVIVE- Centre for Hair Restoration & Skin Rejuvenation, Address for correspondence Sandeep Suresh Sattur, MCh,
Santacruz West, Mumbai, Maharashtra, India HAIRREVIVE- Centre for Hair Restoration & Skin Rejuvenation, 103,
Options Commercial Centre, Dr Vasant Awsare Marg, Milan Subway
Indian J Plast Surg 2021;54:422–434. road, Santacruz West, Mumbai, Maharashtra, 400054, India
(e-mail: drsattur@[Link]).

Abstract Pattern hair loss (PHL) is a condition that worsens with time and the only way it can be
Keywords slowed down is with pharmacological intervention. Pharmacological treatments for
► Pattern Hair Loss PHL, from an evidenced-based perspective with respect to safety and efficacy, are
► Minoxidil limited to only two drugs, minoxidil and finasteride. However, there are a host of drugs
► Finasteride being used, off-label with limited evidence. This article attempts to review the
► Post finasteride literature on this topic, and the authors add to this, with their experience of over
syndrome two decades on incorporating pharmacologic treatments along with hair transplanta-
► Dutasteride tion in their management of PHL.
► Topical finasteride

Introduction 1. The existing deficit in facial aesthetics caused by hair loss

(static component), which is usually addressed by hair
Pattern hair loss (PHL) is the most common form of hair loss
transplantation.
seen in both genders (male pattern hair loss [MPHL] and
2. Potential for hair loss to get worse with time (dynamic
female pattern hair loss [FPHL]). Although not a true medical
component), which is pharmacologically managed.
disease or a threat to life, it is a cosmetic problem which
technically starts at puberty and progresses with age and Both components need to be dealt with to achieve satis-
significantly impacts the quality of life in affected individu- factory outcome. Ensuring that the patient comprehends this
als.1–4 Man has tried to treat hair loss for centuries without a along with the fact that medical management is long-term,
rational approach.5–7 Today, with internet savvy patients, possibly life long, is the key to successful management.
most would have tried a host of remedies, online advocated Pharmacological management is necessary for all patients
treatments, over-the-counter (OTC) products, etc. With so of PHL due to its progressive nature and that includes
many options available, the irony of pharmacological inter- patients undergoing hair transplantation.1,3,4,9,10
ventions is that to date there are only two approved drugs for The hallmark of PHL is gradual reduction in hair shaft
PHL, both of which were not born out of a rational drug diameter, caused by reduced dermal papilla (DP) volume
design but out of serendipity.3,8 Misinformation and resis- with reduced dermal papilla cells (DPCs).11 The objective of
tance to open-ended treatment is the limiting factor in the pharmacological treatment in PHL is to reverse miniaturiza-
pharmacological management of PHL. tion to improve scalp coverage and prevent or slow further
hair thinning and loss.
Currently, the pharmacological options with the best level
Role of Pharmacologic Intervention in PHL
of evidence from the efficacy and safety perspectives are
According to the authors, PHL has the following two topical minoxidil and oral finasteride for MPHL and topical
components: minoxidil l for FPHL.1–4

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 Pharmacological Management of Pattern Hair Loss Sattur and Sattur 423

Table 1 Prior to starting treatment, it is essential to get a Pharmacological Management of Pattern

thorough blood workup mentioned in1 Hair Loss
Tests to be done before medical treatment of PHL The approved drugs with labeled use in PHL, which have level
Complete blood cell count 1 evidence for efficacy and safety with level A recommenda-
Comprehensive metabolic panel tion1,4,19,20 are as follows:

TSH • Topical minoxidil 2% in MPHL and FPHL and 5% twice a day

Iron evaluation (serum ferritin, serum iron, total iron-binding in MPHL and once a day in FPHL.
capacity) • Oral finasteride 1 mg in MPHL.
Free and/or total testosterone and DHT Off-label therapies and those with lower levels of evidence
Vitamins D and B12 and recommendations are as follows:
Additionally, in women—DHEAS and serum prolactin • Dutasteride.
Abbreviations: DHEAS, dehydroepiandrosterone sulfate; DHT, dihy-
• Topical finasteride.
drotestosterone; TSH, thyroid-stimulating hormone. • Spironolactone.
• Cyproterone acetate.
• Peptides.
• Bimatoprost and latanoprost.
The cause of PHL is thought to be multifactorial, of which
some of the elements are identified (androgens and genes)
Minoxidil
and some still under speculation (microscopic follicular
inflammation, oxidative stress, prostaglandins, retinoid Originally, minoxidil was an antihypertensive agent that was
receptors and PPAR pathways, etc.), leaving a wide scope of used largely for patients with severe and refractory hyper-
therapeutic intervention. But, to date, only two molecules tension. The credit for identifying its role in restoring hair
have been found to be helpful and safe.1–4,11–13 goes to dermatologist Guinter Kahn who was the first to
connect increased hair growth as a side effect of minoxidil
usage in 1971.21 Topical use for PHL was formally approved in
Pretreatment Assessment
1986 (2% for MPHL), 1993 (5% for MPHL and 2% for FPHL), in
A confirmed diagnosis made on the basis of a positive family 2006 (5% foam for MPHL), and in 2014 (5% foam for
history, hair loss which is patterned (hair loss in the frontal, FPHL).22,23
midscalp and crown/vertex regions with sparing of occipi-
toparietal region), and presence of anisotrichosis on tricho- How Does Minoxidil Work in PHL
scopy are mandatory before starting treatment (►Table 1).14 PHL in men and women are the only labeled indications for
topical minoxidil. Minoxidil is a piperidino-pyrimidine de-
rivative (2,4-diamino-6 piperidino-pyrimidine-3-oxide)
Hurdles in Initiating and Maintaining
which works like a prodrug, needing conversion to its active
Patients on Pharmacological Treatment
metabolite—minoxidil sulfate (MS)—to exert its pharmaco-
The age group of patients consulting for hair loss varies logical actions. The active metabolite is responsible for
between late teens to those in their sixties or seventies, vascular as well as the follicular actions of minoxidil.22,24
with the majority of them being in their third or fourth MS exerts its antihypertensive effect by opening of plasma
decade of life.15,16 The younger patients are significantly membrane adenosine triphosphate (ATP)-sensitive potassi-
distressed with the hair loss, leading to a negative body um channels (KATP channels).22 The exact mechanism by
image. Moreover, most patients come armed with online which minoxidil promotes hair growth is uncertain and has
information (or misinformation) and bias.17,18 It is one of the been under investigation for the last few decades. Although
challenges faced by doctors to constantly counter this infor- increase in local blood flow has been suggested as a possible
mation and convince the patient of the right treatment mechanism of hair growth, in vitro studies involving follicles
protocols, albeit without any conflict of interest. To take in culture media have shown that minoxidil does indeed
oral or topical medications, which are not curative for the work on the KATP channels present in the hair follicle, even in
rest of their lives, is the most important limiting factor in the absence of any local vasculature.25,26 Various operating
initiating medical treatment. Patient compliance is key to mechanisms contributing to the follicular benefits of minox-
success of pharmacological management of PHL. Regular idil have been put forward. Apart from the effects on KATP
periodic (every 2 or 3 months) photographic documentation channels, minoxidil causes upregulation of vascular endo-
of the hair loss status helps patients to objectively see the thelial growth factor (VEGF), which may be responsible for
improvement in the hair loss status, which spurs them to local angiogenesis, increased local growth factors—VEGF,
persevere to the treatment protocol. Compliance to treat- hepatocyte growth factor (HGF) and insulin-like growth
ment is also facilitated by empathetic and patient fact (IGF1), increased prostaglandin E2 (PGE2) production
counselling. in dermal papilla fibroblasts by stimulation of prostaglandin

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
424 Pharmacological Management of Pattern Hair Loss Sattur and Sattur

Fig. 1 Proposed mechanisms of action of minoxidil on hair follicles.

Fig. 2 Results of minoxidil in pattern hair loss (PHL).

endoperoxide synthase, upregulating the b catenin pathway, Fig. 4 Results of minoxidil in pattern hair loss (PHL).
decreased catagen by inhibiting TGF b-induced apoptosis of
hair matrix cells, activating ERK and aKt pathways as well as All these actions translate into improved hair growth. Short-
activating adenosine1 and 2 receptors in DPCs; finally, it may ening of telogen results in increased shedding after initiating
also play a role suppressing androgen receptor (AR)-related treatment. This is seen within a week of starting minoxidil
functions (►Fig. 1).22,24–28 and may last a few weeks. The benefits are objectively
Application of minoxidil causes anagen prolongation, noticeable between 6 to 12 months after starting therapy
delays catagen progression, and shortens telogen.22,26,29 (►Figs. 2, 3, 4).

Pharmacokinetics of Topical Minoxidil

Direct follicular action without systemic effects justifies
topical use of minoxidil30 but hurdles of transdermal ab-
sorption need it to be mixed with water, ethanol and
propylene glycol (PG).26 PG is necessary to improve absorp-
tion but is also the cause for irritation of the skin. Limited
systemic absorption (less than 99%) limits the possibility of
vascular effects.31 Minoxidil action on the follicle is depen-
dent on the expression of sulfotransferase enzyme in the hair
follicles, which can vary in the population, and this is the
reason for differential effects of minoxidil.32 The levels of this
enzyme can be impacted favorably (retinoic acid) or unfa-
Fig. 3 Results of minoxidil in pattern hair loss (PHL). vorably by certain substances (aspirin, salicylates).32,33

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
 Pharmacological Management of Pattern Hair Loss Sattur and Sattur 425

Adverse Effects with Topical Minoxidil

Topical minoxidil is a safe drug which is evident from the fact
that it is an OTC medication in many countries. But some
minor adverse effects may be seen in some patients. These
could be temporary and gradually reduce with time but
sometimes the irritation is more severe, mandating discon-
tinuation or modification of therapy.
The most common adverse effect which is also responsi-
ble for patients defaulting on treatment is PG-induced irri-
tant dermatitis (contact allergy to minoxidil is rare). This can
be significant in a subset of patients, mandating discontinu-
ation of the treatment or change of formulation. The irrita-
tion is directly proportional to the minoxidil concentration
(5% > 2%) ►Fig. 5.26
Another reason why patients discontinue minoxidil is the
initial increased hair fall caused due to shortening of telogen
phase, and this should be mentioned to patients while
starting minoxidil therapy, but the authors feel that this
could be a pointer to its effectiveness in that patient. Fig. 6 Increase in facial hair after minoxidil application.
Other adverse effects that may be seen are hypertrichosis,
especially on the face in women. This is linked to the
concentration of minoxidil (5% > 2%) or could be due to
improper application.26 It is always a good idea to photo-
graph the face with the side burn and chin regions before
starting treatment, so as to document any increase in facial
hair with minoxidil usage ►Fig. 6.
Many patients are reluctant to use it in work or social
situations, as the hair sometimes appears to be dry, dull, and
stiff. This could probably be due to improper application
(delivering most minoxidil onto the hair instead of the scalp),
Fig. 7 Minoxidil crystal precipitation on hair
leaving precipitate of minoxidil on the hair shaft (►Fig. 7).
This reluctance can be overcome by educating the patient on
correct application techniques and use of conditioners and
leaving on serums applied between minoxidil applications
(►Fig. 8a and b).34
It is extremely rare for patients to complain about hypo-
tension, but some patients may complain about palpitations,
irritation or burning of eyes, weight gain, etc.35 Although it
qualifies as an OTC product, topical minoxidil can have an
impact on the cardiovascular system.35 This may become
significant in patients with cardiac compromise. Cardiolo-
gists’/physicians’ opinion regarding safety of starting topical
minoxidil in such patients is important. Although not com-

Fig. 8 (a) Dull look after minoxidil application. (b) Addressing dull
look after minoxidil application with leave on serum.
Fig. 5 Irritant dermatitis caused by minoxidil application.

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
426 Pharmacological Management of Pattern Hair Loss Sattur and Sattur

mon, some patients do complain of headaches.26 Lowering Oral Minoxidil

the dose helps in these cases. The minoxidil story seems to be coming to a full circle now
with studies exploring the potential use of oral minoxidil
How to Use Topical Minoxidil (OM) in treating hair loss. The proponents of OM have
For patients to reap benefits out of the use of topical rationalized its use in this form to overcome the disadvan-
minoxidil, they need to ensure correct application of minox- tages of topical applications, namely, scalp irritation, daily
idil. It is helpful to demonstrate to the patient the correct way twice application, unpredictable outcomes, etc.41,42 Differ-
to apply minoxidil or direct them to videos which demon- ent dosing regimens have been utilized in scarring and
strate the same. Minoxidil is for application to scalp, and for nonscarring alopecia, varying from 0.25 to 5 mg daily with
this, the scalp has to be dry. women requiring lower doses than men.42 However, the
Minoxidil is applied to the scalp as a liquid or foam, ideally studies have shown that efficacy of 1mg OM is similar to 5%
right after bathing, so it is not washed away from towel-dried topical minoxidil. The adverse effects are seen in fair number
scalp (one need not blow dry it, it is okay if it is slightly of patients (20%) using OM, of which hypertrichosis is the
damp). Maximum efficacy requires application two times most frequent (significant enough to mandate laser hair
daily to the affected area for men; one time daily for women reduction).43 In the authors’ opinion, the risk benefit ratio
(if using 5%). No other application should be made on the of OM as compared with topical minoxidil and the fact that
scalp for at least 4 hours after minoxidil application.36 There the available evidence for OM is not of very high quality and
is no need to massage it onto the scalp. It is important to does not justify use of OM routinely in the management of
avoid the eyes and make sure to wash hands after PHL and that topical minoxidil is still the first-line thera-
application. py.26,43,44 More studies would be needed to elucidate safety
Its off-label uses are found in the following area: alopecia and efficacy of OM and justify its use as the first-line therapy
areata, beard augmentation, eyebrow augmentation, post- in PHL. As a strict off-label indication with detailed informed
chemotherapy hair fall and telogen effluvium,26 and some consent, and after proper cardiac evaluation, it could be
have recommended for preoperative use on chest to get more considered in motivated young healthy adults with no
follicles in anagen phase before harvesting them with follic- comorbidities who do not tolerate topical minoxidil or see
ular unit extraction (FUE).37 benefits in spite of proper and diligent usage.45,46

Minoxidil Combinations and Formulations Finasteride

Significant irritation caused by PG have prompted various As with minoxidil, serendipity once again played a role in
attempts to overcome these issues by replacing PG and identifying finasteride as a treatment for MPHL, when it was
alcohol with alternative solvents. PG-free preparations observed to promote hair growth in bald men who were
were designed (PG-free foam) in a bid to reduce the irritation taking it for benign prostate hyperplasia (BPH), leading to its
and ensure patient compliance to the treatment.26,38 As a approval by US Food and Drugs Administration (FDA) in 1997
personal experience, the authors have observed that the for the treatment of MPHL (androgenic alopecia [AGA]).8
stability of locally available minoxidil foam preparations in
tropical climate is not optimal and the minoxidil containers How does Finasteride Work in MPHL
need to be refrigerated before use. What we know about androgens and MPHL
Minoxidil absorption is known to increase with the con-
• There is increased expression of ARs, 5 α reductase type 2
centration of minoxidil, but studies comparing 5% minoxidil
enzyme (SRD5A2) and dihydrotestosterone (DHT) in the
with 10% found that the former was superior to the latter in
follicles of the balding regions.
hair regrowth and caused less irritation at the same time.39
• There is decrease aromatase enzyme expression in the
The increased irritation does not justify usage of higher
follicles of balding scalp.
concentration, and the authors do not recommend usage
• Blocking conversion of testosterone (T) to DHT delays or
of strengths higher than 5%.
prevents progress of hair loss in MPHL.47–52
Attempts have been made to add minoxidil with other
pharmacological actives and not always successfully.40 The contributory role of androgens in FPHL is still not
Tretinoin is thought to increase the absorption of minoxi- clear.52,53 The role of androgens in FPHL becomes significant
dil and also upregulate the expression of sulfotransferase, if there is presence of clinical hyperandrogenism (hirsutism,
but studies have revealed that using a combination of weight gain, irregular menses, difficulty in conceiving) or
minoxidil 5% þ tretinoin 0.01% once a day was not superior evidence of biochemical excess of androgens. Detailed as-
to minoxidil 5% twice a day. This combination can cause sessment to rule out hyperandrogenism is a must in patients
significant irritation and may also interfere with minoxidil with FPHL, which includes testosterone, free and total, DHT,
absorption. There is a possibility that if retinoic acid is dehydroepiandrosterone sulfate (DHEAS), prolactin and sex
applied a couple of hours before minoxidil application, hormone-binding globulin.51
then it may prove beneficial, but more studies are needed Steroid type II 5α -reductase (SRD5A2), an intracellular
on the same.34 enzyme present in the outer root sheath in the DP of
Topical combination of minoxidil with finasteride is dis- balding follicles, converts T into DHT, which is the preferred
cussed in the following section. ligand for AR.54 DHT binding to the AR puts into motion a

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
 Pharmacological Management of Pattern Hair Loss Sattur and Sattur 427

cascade of events, which ultimately leads to hair follicle

miniaturization.
Finasteride, a synthetic 4-azasteroid compound, is a spe-
cific and competitive inhibitor of SRD5A2, which converts T
into 5α DHT.55,56 Finasteride is known to reduce the scalp
and serum DHT levels by 60 to 70%.51,54 Various studies of
finasteride 1 mg orally taken daily have shown cessation of
hair loss progression and improved hair growth in a signifi-
cant number of patients. Finasteride usage in MPHL has
shown to increase the duration of anagen with increase in
hair count, improved scalp coverage, and increased hair
mass.1,56 Finasteride does not affect T levels or binding of
DHT to AR and therefore does not possess androgenic, Fig. 10 Results of using topical minoxidil and oral finasteride.
antiandrogenic, estrogenic or antiestrogenic, or progesta-
tional or steroid hormone-related properties.56,57

Pharmacokinetics
Finasteride when taken orally has a mean half-life of
approximately 6 hours, mandating a daily dosage to main-
tain uniform blood levels. Extensive hepatic metabolism is
by the cytochrome P450 enzyme system, specifically
CYP3A4 enzyme subfamily. Finasteride does not have any
major drug interactions56,58 but drugs like erythromycin or
rifampicin, which impact CYP3A4 enzyme, should be used
carefully with finasteride, and the authors recommend
evaluation of liver function before starting treatment.57
Finasteride is recommended in the dosage of 1 mg daily
for treatment of MPHL. Although various dosages ranging
from 0.01 mg to 5 mg/day have been tried, 1 mg dosage has Fig. 11 Results of using topical minoxidil and oral finasteride.
been found to be optimal.57
Finasteride has level 1 evidence for efficacy to prevent
progression and improve hair loss in MPHL.1,4,19,20,32,54,56–59 in the transplanted and surrounding areas. Improvement of
Studies have revealed that the hair count and weight start these hairs not only stabilizes hair loss progression but also
show increase by approximately 6 months and the improve- augments hair transplant outcomes. This approach goes a
ment continues at least for up to 5 years.20,57 Treatment long way in optimizing donor supply over patient’s lifetime
started earlier in the course of hair loss always responds and increasing the interval between two trans-
better (►Figs. 9, 10, 11). plants.9,10,60,61 When planning a transplant, it is important
The authors have routinely used a combination of topical to put these considerations across to the patient and empha-
minoxidil and oral finasteride as an adjunct to hair trans- size the benefits of a holistic approach (►Fig. 12).
plant surgery to tackle the dynamic and static aspects of
MPHL. When used preoperatively (at least 12–16 weeks), it Adverse Effects of Oral Finasteride
helps to improve yield by prolonging anagen and also helps to Finasteride has been widely used since 1992 for BPH and
reduce postoperative telogen effluvium. When used postop- 1997 for MPHL, and millions of patients having used it and
eratively, medications help to improve the vellus hair present benefitted from it since then. This is a reflection of its safety
and efficacy. However, the controversy surrounding the
adverse effects continues, confounding the doctors as well
as patients about its role in therapy.
The adverse effects related to finasteride usage can be
divided into sexual (reduced libido, erectile dysfunction
[ED], ejaculatory problems) and nonsexual (breast tender-
ness and enlargement; depression; hypersensitivity reac-
tions including rash, pruritus, urticaria, and swelling of the
lips and face; and testicular pain).
The widespread information or misinformation on the
Internet regarding the potential adverse effects of finaste-
ride, along with the fact that United States National Institutes
of Health added a link for postfinasteride syndrome to its
Fig. 9 Results of using topical minoxidil and oral finasteride. Genetic and Rare Disease Information Centre,62 has created a

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
428 Pharmacological Management of Pattern Hair Loss Sattur and Sattur

Fig. 12 Showing beneficial effects of oral finasteride and topical minoxidil in hair transplant outcomes.

bias in the minds of patients as well as doctors who are very with finasteride).62,73 The art of counselling is to develop
reluctant to use this medication. innovative ways to reduce nocebo effects without withhold-
The incidence of sexual adverse effects with SRD5A ing information or scaring the patient.78 In practice, the
inhibitors quoted in literature range from 0.9 to 38%.62 Of authors navigate this difficult issue by sharing patient expe-
the sexual adverse effects, ED is more common than ejacula- riences and emphasizing the positive outcomes of finasteride
tory dysfunction and loss of libido.1,62 Literature on adverse with before and after pictures, downplaying the expectations
effects of finasteride includes different doses, different drugs of adverse effects (without distorting facts), being empathet-
(finasteride and dutasteride) with different indications (BPH ic to the patient’s situation and, most importantly, answering
and MPHL), and different age groups. There are some pub- all their queries patiently. An effort is made to get the history
lications which link finasteride usage with sexual adverse regarding any existing sexual or psychiatric problems faced
effects62–67 and others which state that the association is not by them. If the patient has history of any sexual problems or
significant or does not exist.68–73 More importantly, meta- psychological issues, starting finasteride is avoided or
analysis of data regarding finasteride adverse effects in MPHL deferred.
is not associated with statistically significant incidence.68–70 Another adverse issue linked to finasteride is depression.
This could be probably due to the lower dosage used and the Over the years, increased usage and subsequent postmarket-
younger study population. ing feedback have been responsible for adding depression to
ED has two components—organic (levels of androgens and the list of adverse symptoms in the package insert of finas-
normal anatomy of genitals) and psychogenic, and both of teride.62 SRD5A enzyme is not only responsible for reduction
these components may have an intricate relationship.70 of T to DHT but also progesterone and deoxycorticosterone to
Finasteride lowers serum DHT without altering T levels dihydroprogesterone (DHP) and dihydrodeoxycorticoster-
which, due to its humoral endocrine and local paracrine one (DHDOC), respectively. 3 α reduction converts DHT,
effects, is more relevant or critical to maintaining erectile DHP and DHDOC to steroid metabolites, which act on the
function than the locally acting DHT.68,74 Most studies gamma-aminobutyric acid (GABA) A receptors. The hypoth-
emphasize the importance of T in erectile physiology, which esis for the cause of depressive symptoms occurring with
is highlighted by the fact that patients with congenital finasteride therapy is linked to reduced levels neuroactive
deficiency of SRD5A have normal erectile physiology.68,74,75 steroids, caused by SRD5A inhibition. Levels of neuroactive
On a subjective level, patients answering the International steroids have been found to be inversely proportional to
Index of Erectile Function questionnaire showed no differ- various psychiatric conditions including depression.79 Ani-
ence in scores before and 6 months after starting finasteride mal studies have yielded evidence which supports the fact
1 mg.76,77 Another factor is that hair loss may itself cause that finasteride is a depressogenic drug, but human studies
depression, lead to sexual problems, and confound the have not corroborated the same. This could be due to species
occurrence of ED. difference in finasteride activity or the accuracy of the
From a psychogenic perspective, one possible explanation modalities used to assess depression-like symptoms in ani-
for the sexual adverse effects could be the “nocebo effect,” mals.79 Recent publications however have found the risk of
which is not directly related to the specific pharmacological developing depression after finasteride therapy to be low and
effect of the drug, but due the information about the drug not statistically significant.80,81 However, more studies
being given during counselling (especially sexual side effects would be needed to validate these findings and till then it

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
 Pharmacological Management of Pattern Hair Loss Sattur and Sattur 429

would be a good practice to rule out any preexisting psychi- motility, semen volume, and sperm concentration from
atric issues in the patient and also consider and discuss the baseline but no change in sperm morphology. These changes
possible sexual side effects and risk of depression with however were not statistically significant at 52 weeks. More-
patients prior to starting finasteride therapy.65 over, these changes reverted to baseline after discontinuing
treatment.74 Another study conducted in the male infertility
Finasteride and Prostate Cancer population showed improved semen parameters, including
The Prostate Cancer Prevention Trial (PCPT) results showed increased sperm count after discontinuation of finasteride.95
that finasteride users were 25% less likely to develop cancer This probably indicates that finasteride may not significantly
of the prostate. But the controversial finding was that the impact sperm parameters, but in patients with conditions
incidence of high-grade cancers was 0.7% in finasteride related to infertility, an amplification of the negative influ-
users.82,83 In view of these findings, the FDA subsequently ence of finasteride could occur.96 Keeping this in mind, the
in 2011 issued a safety warning of developing high-grade authors defer finasteride therapy in young men who are
cancer as an adverse effect of finasteride.83 Various studies planning to start their family, especially if the couple is
conducted later as well as further analysis of the PCPT having difficulty in conceiving.
outcomes by factoring in the biases and accounting for PSA
(increased sensitivity), showed that finasteride usage is not Postfinasteride Syndrome
linked to increased incidence of high-grade prostate Postfinasteride syndrome (PFS) is a collection of adverse
cancers.83–86 effects causing sexual, neuropsychiatric, and physical symp-
Prostate-specific antigen (PSA) is an important tumor toms which develop with use of finasteride for MPHL or BPH
marker for prostate cancer, and finasteride is known to and which persist after discontinuation of treatment.97–99
decrease the levels. There have been various recommenda- Majority of the studies which reported on PFS were found to
tions about interpreting PSA levels in patients taking finas- be of low quality, having come from doctors who are not
teride. As the levels are known to decrease, a compensatory treating hair loss, and most of them suffered from a strong
adjustment of the PSA concentration (to multiply the value selection bias and nocebo effect.100 Although most individu-
by two) is recommended to get the corrected value.87,88 als who suffer from PFS have homogenous symptoms, the
However, this correction is not valid for long-term manage- medical community is still not recognizing this as a medical
ment, and any increase above the baseline is to be viewed condition, as most reports cannot deny nor confirm its
with suspicion even if it is in normal range.89 The authors existence as a nosological entity.98,101 Nevertheless, it has
routinely advise PSA estimation in all male patients above been added to the Genetic and Rare Disease Information
the age of 45 years who are agreeable to start with finaste- Centre by the United States National Institutes of Health.62
ride. The test is then repeated after 6 months of therapy and One of the studies has labeled PFS as a delusional disorder of
then annually. The 6-month value is taken as the new the somatic type, in a person with probably a personality
baseline and any change in that value, even if it is in the disorder, with the potential of a mass psychogenic illness due
normal range, is taken seriously and further investigations to its media coverage.101 Most observations pertaining to PFS
advised. are mainly based on self-reporting of symptoms by the
patients, and limited medical studies have not been able to
Finasteride and Male Breast Cancer identify molecular mechanisms and/or genetic determinants
A report published by Medicines and Health care products underlying these adverse effects.99 The authors have not
Regulatory Agency (MHRA), United Kingdom, in 2009 men- seen a single case of persistent adverse effects with finaste-
tioned the occurrence of male breast cancer (MBC) in ride therapy in a practice over two decades, but they make it
patients who received finasteride.90 Another study in 2018 a point to watch out for the red flags like a history of
also suggested possible association between finasteride use preexisting psychological problems such as depression or
and MBC but added that this could also be attributed to the personality disorders before choosing to start with finaste-
increased surveillance and the way data was collected ride therapy.
(ascertainment bias), which could confuse the inference.91
In 2019, a large case-control study using individual-level Topical Finasteride
registry data from Denmark, Finland, and Sweden, which Although oral finasteride is approved for treatment of MPHL
adjusted for confounding factors, showed that there is no due to the incidence of small but significant number of
association between finasteride usage and MBC.92 adverse effects and reluctance of patients to use oral
finasteride; topical finasteride was explored as an alterna-
Finasteride and Fertility tive. Topical finasteride is an off-label use of finasteride for
A randomized, double-blind placebo-controlled study, MPHL. In India, it is available as a combination 0.1%
which reviewed the effect of 1 mg finasteride on fertility in finasteride with minoxidil 5%.102,103 The study by Casserini
young men, showed no significant effects on sperm concen- et al compared pharmacokinetics of topically applied finas-
tration, total sperm per ejaculate, sperm motility, or teride with the standard oral finasteride 1 mg. The plasma
morphology.58,93,94 DHT suppression was almost the same with topical and oral
However, a similar study using 5 mg dose did show a forms of finasteride, but at the same time, the maximum
statistically significant reduction in sperm count, sperm plasma concentration (Cmax) of finasteride was much

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
430 Pharmacological Management of Pattern Hair Loss Sattur and Sattur

be more potent than finasteride, as it can decrease serum

DHT by more than 90%, while finasteride decreases serum
DHT by 70%.54 Different studies compared dutasteride versus
finasteride to assess its efficacy and safety. It has been found
that dutasteride is slightly more efficacious than finasteride
and the adverse effect profile is better than finasteride.107,108
The dosage used is 0.5 mg daily. As dutasteride has a much
longer half-life and there is limited data of long-term safety,
the authors do not use it as a first-line treatment in MPHL.
The authors offer it as an off-label drug to patients who have
plateaued in their response to finasteride or have not
responded to finasteride only after proper counselling.
Fig. 13 Improved scalp coverage with topical finasteride and
minoxidil. Antiandrogens
FPHL with evidence of clinical or biochemical androgen
excess would be suitable for antiandrogen therapy as com-
pared with or without any evidence of hyperandrogenism.19
Hormonal treatment for FPHL can be divided into two broad
groups, antiandrogens and estrogenic (or antiestrogenic)
drugs.4 Two commonly used drugs are cyproterone acetate
and spironolactone, although evidence of efficacy for any of
these treatments is limited.54

Spironolactone
It is by far the most common antiandrogen used off-label in
FPHL.1,4 Spironolactone is a potassium-sparing diuretic,
Fig. 14 Improved scalp coverage with topical finasteride and structurally related to aldosterone (antagonist), which acts
minoxidil. as an antiandrogenic by competitively inhibiting the andro-
gen receptor in target tissues and also inhibits ovarian
production of androgens, reducing the levels of total T and
lower with topical finasteride.104 So, in effect an equal competitively blocking the AR.1,4,54 The dosage ranges from
therapeutic benefit was achieved without increasing the 50 mg/day to 200 mg/day for at least 6 months. Some
systemic exposure to finasteride; therefore, potentially patients may face adverse effects like postural hypotension
minimizing the incidence of adverse effects. The benefits and electrolyte imbalance.4 It is contraindicated in MPHL.
in terms of hair growth are comparable to oral finasteride
(►Figs. 13, 14, 15).102,103,105 Cyproterone Acetate
Cyproterone acetate (CA) is an AR blocker and potent pro-
Dutasteride gesterone derivative that prevents dihydroxytestosterone
Dutasteride, a potent type I and type II 5-α reductase from binding to the AR and inhibits release of follicle-
inhibitor, and the logic of using this is that dual 5α-reductase stimulating hormone (FSH) and luteinizing hormone (LH),
inhibition could result in greater efficacy than is observed in thereby reducing testosterone levels.1,4,54 CA is not approved
selective type 2 inhibition, and this dual inhibition could in the United States. It is available combined with ethynyl
prevent type 1-mediated synthesis of DHT106 It is approved estradiol as an oral contraceptive in many countries (2 mg CA
for BPH but is also prescribed as an off-label treatment for with ethinyl estradiol 0.035 mg) and started on day 1 of the
pattern hair loss.1,107 It has a high level of evidence for safety menses for 21 days, followed by a break of 7 days. Studies
and efficacy, as per the Japanese guidelines.20 It is thought to have shown statistically significant improvement in hair

Fig. 15 Improvement with minoxidil and later with minoxidil and finasteride combination

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
 Pharmacological Management of Pattern Hair Loss Sattur and Sattur 431

growth as compared with placebo.4 It is important to keep a the typical characteristics of pattern hair loss. Nutrient
track of liver function, as it can cause liver toxicity. The supplementation has been used empirically to address
authors have used it in patients of FPHL who also have hair loss concerns, with many patients using OTC products
polycystic ovarian disease (PCOD). to manage hair loss.111–113 However, the role of nutrient
deficiencies in causation of pattern hair loss has never been
Prostaglandin Analogues really verified.112 However, in patients of pattern hair loss
The beneficial effects of prostaglandin analogue on hair who have coexisting deficiencies of certain nutrients like
growth were noted when eyelashes improved with topical vitamin D or iron, supplementing these can improve the
use for treatment of glaucoma. PGD2 levels are associated outcomes in pattern hair loss.113 Data on the role of nutri-
with miniaturization in balding scalp while levels of PGE2 ent supplementation in the absence of deficiency is ex-
and PGF2 are reduced.59 PGF2 analogues bimatoprost and tremely limited.112
latanoprost are known to promote hair growth. But currently
there is insufficient evidence to use them in PHL.4,20
Summary
Ketoconazole The goal of the pharmacological management of PHL is to
Ketoconazole is an antifungal agent available as a shampoo in prevent further progression of hair loss and promote hair
combination with zinc pyrithione. It is thought to have local regrowth and improve scalp coverage. The key to successfully
DHT-blocking effects as well as an anti-inflammatory ef- management of PHL using medications is proper diagnosis,
fect.1,4,20 Furthermore, change in the microbiome of the hair adequate patient counselling, regular periodic follow-up,
follicle, causing microinflammation in the perifollicular re- watching for adverse issues, and constant reassurance to
gion, is thought to be one of the factors implicated in PHL.1,59 the patient. The success of the treatment is to a large extent
Use of ketoconazole with its antifungal properties and anti- controlled by patient compliance and ensuring this is impor-
inflammatory properties of zinc pyrithione has worked well tant. Emphasizing the following points is critical for its
in conjunction with topical minoxidil.59 A few noncontrolled success:
studies have shown benefits in MPHL as well as in FPHL with
androgen excess.1,4,20,59 1. That PHL is a condition that is going to progress with time
and medical management would be necessary either
Saw Palmetto (Serenoa repens) alone or in conjunction with hair transplantation.
Saw palmetto (SP), a botanical extract from the berries of 2. It is critical to give the patient all options of dealing with
Serenoa repens, is one among the many naturally occurring his or her hair loss, explaining the pros and cons of each
SRD5A inhibitors which has gained popularity as a magical approach. With all the options advertised on the Internet
remedy for MPHL.59,109,110 Very few studies of efficacy of SP and social media, patients tend to be overwhelmed and
in PHL exist and most of the data on SP is from studies of its confused. Patience and empathy along with clear recom-
use in BPH.110 It is listed in US Pharmacopeia under food mendations are helpful to the patient, especially young
supplements and available as dried berries or tablets of the men who are in denial and do not accept medical therapy
extract. The dosage is 160 mg twice a day.109 In absence of and would rather proceed with hair transplantation.
strong evidence of efficacy, it cannot be recommended. 3. It is important to mention the benefits and the adverse
Other botanicals which have been proposed to be used in effects without highlighting them; periodic photographic
PHL are green tea (C sinensis), pumpkin seed (C pepo), documentation of the progress is crucial and always
rosemary (Rosmarinus officinalis), grape seed (Vitis vinif- helps the patient to stay on track with the treatment.
era), and licorice (G glabra). These do not have supporting Important to point out that majority of the patients do
data to recommend their use in PHL. not encounter adverse effects.
4. Medical therapy is best started early, used daily, and
Peptides continued for life.
Botanical extracts have been used to treat PHL, especially 5. Currently, there are only two approved medications to
biomimetic peptides such as acetyltetrapeptide-1 and 3, achieve this along with off-label uses of other medica-
which are combined with an isoflavone derived from red tions, but in terms of efficacy and safety, only topical
clover (biochanin-A). There is very little literature support, minoxidil and oral finasteride in MPHL and topical mi-
and their role in management of PHL is not significant. noxidil for FPHL have the evidence to support their use.
Probably, they may play a role of placebo. 6. However, it is important to wait for at least 6 months
before expecting and visible change. It is ideal to combine
Nutritional Supplements minoxidil and finasteride in MPHL as they work
The hair follicle is a miniature organ with a high cellular synergistically.
turnover and a high metabolic rate, which mandates a 7. Pharmacotherapy plays an important role in the hair
constant supply of energy and nutrients. So, obviously transplant setting. Use of medications perioperatively
nutrient deficiencies will impact structure and growth of helps to optimize the amount of donor harvest and at
hair.111,112 The kind of hair loss seen with nutrient defi- the same time augments the results of the transplant,
ciencies is generally of a diffuse variety and does not have thereby conserving the donor area for future needs.

Indian Journal of Plastic Surgery Vol. 54 No. 4/2021 © 2021. Association of Plastic Surgeons of India. All rights reserved.
432 Pharmacological Management of Pattern Hair Loss Sattur and Sattur

8. Initial hair fall occurring with treatment should not be a 16 Krupa Shankar D, Chakravarthi M, Shilpakar R. Male androge-
cause of worry and usually settles in 8 to 10 weeks. It is netic alopecia: population-based study in 1,005 subjects. Int J
always helpful to educate the patient on the proper Trichology 2009;1(02):131–133
17 Gupta AK, Ivanova IA. Analysis of YouTube hair loss treatment
technique of minoxidil application.
information: What makes for engaging content? Dermatol Ther
9. Cosmetic management for dealing with dry and dull hair (Heidelb) 2020;33(06):e14244
after minoxidil application must be shown to the patient. 18 Gupta AK, Ivanova IA. Hair loss treatment information on Face-
10. Sexual side effects after oral finasteride therapy, if they book: content analysis and comparison with other online sour-
do occur, are usually seen after at least 6 months of ces. J Cosmet Dermatol 2021;20(02):577–583
19 Kanti V, Messenger A, Dobos G, et al. Evidence-based (S3)
therapy. It is important to reassure the patient. If they are
guideline for the treatment of androgenetic alopecia in women
not severe, it is okay to continue with the finasteride after
and in men - short version. J Eur Acad Dermatol Venereol 2018;
counselling or may be discontinued with the understand- 32(01):11–22
ing that the hair loss will return to pretreatment stage. 20 Manabe M, Tsuboi R, Itami S, et al; Drafting Committee for the
There is also the option of using topical finasteride with Guidelines for the Diagnosis and Treatment of Male- and Female-
minoxidil in apprehensive patients. Pattern Hair Loss. Guidelines for the diagnosis and treatment of
male-pattern and female-pattern hair loss, 2017 version. J
Conflict of Interest Dermatol 2018;45(09):1031–1043
None declared. 21 Stafford N, Kahn G. BMJ 2014;349:g7798
22 Rossi A, Cantisani C, Melis L, Iorio A, Scali E, Calvieri S. Minoxidil
use in dermatology, side effects and recent patents. Recent Pat
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