DOI: 10.1111/jdv.

15171 JEADV

ORIGINAL ARTICLE

A randomized, double-blind controlled study of the efficacy

and safety of topical solution of 0.25% finasteride admixed
with 3% minoxidil vs. 3% minoxidil solution in the treatment
of male androgenetic alopecia
P. Suchonwanit,* P. Srisuwanwattana, N. Chalermroj, S. Khunkhet
Division of Dermatology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
*Correspondence: P. Suchonwanit. E-mail: poonkiat@hotmail.com

Abstract
Background The synergism of combined use between oral finasteride and topical minoxidil has been established in
treating androgenetic alopecia among men. However, the concern regarding adverse effects of finasteride use has been
rising.
Objective To compare the efficacy and safety of topical solution of 0.25% finasteride admixed with 3% minoxidil vs.
3% minoxidil solution in men with androgenetic alopecia.
Methods Forty men aged 18–60 years with androgenetic alopecia were randomized to 24 weeks of treatment with a
finasteride/minoxidil or minoxidil solution twice daily. Primary efficacy endpoint was the change from baseline in hair
density and hair diameter at week 24. Secondary endpoints included global photographic assessment by treatment-
blinded investigators and subjects. Changes in plasma dihydrotestosterone levels and adverse events were recorded.
Results At week 24, the combined solution of finasteride and minoxidil was significantly superior to minoxidil alone in
improvements of hair density, hair diameter and global photographic assessment (all P < 0.05). About 90% of patients
treated with the combined solution experienced moderate to marked improvement. The combined solution also had min-
imal effect on plasma dihydrotestosterone levels, approximately 5% reduction. There were also no systemic adverse
events reported by patients in both groups.
Conclusion Treatment with topical solution of 0.25% finasteride admixed with 3% minoxidil was significantly superior
to 3% minoxidil solution for promoting hair growth in male androgenetic alopecia, and well tolerated.
Received: 5 July 2017; Accepted: 20 June 2018

Conflict of interest
None declared.

Funding source
The authors have no relevant financial interest in this article.

Introduction androgen, appears to be an important causative factor.1–3 The

Androgenetic alopecia (AGA), characterized by a progressive
miniaturization of terminal scalp hair with a pattern distribu-
tion, is the most common cause of hair loss in adults. The aetiol-
ogy is considered as multifactorial, involving a complex
interplay between several genes, androgens and environmental
factors. The transformation into miniaturized hair is largely dri-
ven by androgens. Although the exact molecular mechanisms
are not fully understood, dihydrotestosterone (DHT), a potent
This study was approved by the MU-IRB (Mahidol University Institutional
Review Board) on June 17, 2015 (protocol number 06-58-20).
Clinical trials registration information: Clinicaltrials.in.th, identifier
TCTR20160910002.
enzyme 5a-reductase is required to convert testosterone into
DHT, yielding more powerful actions.
Currently, only two medications have been approved by the
US Food and Drug Administration for treatment of male AGA:
finasteride, a 5a-reductase inhibitor, 1 mg daily and topical
minoxidil (2% solution, 5% solution and 5% foam). The effec-
tiveness of both drugs in improving the disease has been demon-
strated in several well-designed studies.4–10 Combined use of
oral finasteride and topical minoxidil has also shown better ther-
apeutic efficacy during 1-year follow-up, compared to the use of
each single treatment.11,12
Long-term treatment with oral finasteride for hair loss is gen-
erally well tolerated. Adverse events have been reported only in a

JEADV 2018, 32, 2257–2263 © 2018 European Academy of Dermatology and Venereology
2258
minority.4–7 In spite of low incidence, some adverse effects, in
particular sexual dysfunction, may raise a significant concern
and impact on patients’ quality of life. To minimize systemic
adverse effects, topical finasteride has been suspected to be a
potential alternative option. Treatment with a solution of 0.005–
0.5% finasteride in men with AGA showed a greater increase in
hair growth comparing with the placebo group.13–15 When com-
pared to current standard treatment, finasteride 1 mg daily, 1%
finasteride gel revealed relatively similar therapeutic results in
promoting hair growth without any systemic side-effects.16
By reason of the synergism of duotherapy, topical formula-
tions containing both finasteride and minoxidil would provide
better outcomes as well as improve patient compliance. In the
previous studies, a solution of 0.1% finasteride admixed with
3% or 5% minoxidil showed greater improvements in hair count
and global photographic assessment, compared to the solution
of minoxidil alone.17,18 However, the difference in hair count
did not reach statistical significance. There were also neither sys-
temic adverse events nor differences in local side-effects between
both groups.
To enhance therapeutic efficacy, we decided to develop a new
mixed solution with a higher concentration of finasteride, 0.25%
finasteride and 3% minoxidil in an ethanol/propylene glycol/wa-
ter base. From the recent studies, the ability of 0.25% finasteride
solution in reducing plasma and scalp DHT levels was demon-
strated to be equivalent to that of finasteride 1 mg daily while
the plasma exposure was about 9-fold lower.19,20 Therefore,
0.25% finasteride solution has been suspected to be an optimal
concentration in order to yield therapeutic benefits and mini-
mize systemic drug absorption. This study aimed to determine
the clinical efficacy and safety of a topical formulation of 0.25%
finasteride admixed with 3% minoxidil (FMX) in the treatment
of male AGA, in comparison with 3% minoxidil solution (MX).
Methods
Study design
This was a randomized, double-blind controlled trial to assess
the efficacy and safety of FMX solution vs. MX solution in men
with AGA, conducted at a university-based hospital (Ramathi-
bodi Hospital, Mahidol University, Bangkok, Thailand). Partici-
pants were randomized to apply 1 mL of either FMX or MX
solution twice daily for 24 weeks, with an allocation ratio of
1 : 1. Randomization with a block size of 4 was generated using
a random number table. Patients and investigators were blinded
to treatment allocation until study completion.
Study products
FMX and MX solutions were prepared and stored in identical
bottles, each labelled with a container number, dosing instruc-
tions, storage conditions, and caution statements. Finasteride
has been considered hazardous as belonging to a group of
JEADV 2018, 32, 2257–2263
Suchonwanit et al.
endocrine disruptors which yield reproductive toxicity in
humans and animals. Handling with special cautions was used
to prevent public and environmental exposures. Subjects were
asked to return their remaining solution at every follow-up visit.
A balance of remaining study products and product accountabil-
ity were well maintained throughout the study. At the end, all
unused study solutions, as well as empty containers, were col-
lected and processed according to the hospital policies in medi-
cal waste management.
Study participants
Men between 18 and 60 years of age with AGA classified as type
III vertex, IV and V by the Norwood-Hamilton classification
were eligible for this study. Subjects were instructed to maintain
the same hair colour, style and length during the study. Principal
exclusion criteria included use of finasteride or dutasteride
within 18 months, use of other topical or systemic drugs with
hair growth-promoting properties in the past, and patients with
diseases that may affect hair growth. Additional exclusion crite-
ria were other scalp diseases and a history of allergic reaction to
any ingredient in the solutions. This study (protocol number 06-
58-20) was approved by the Mahidol University Institutional
Review Board on June 17, 2015 (clinicaltrials.in.th identifier:
TCTR20160910002). Date of first enrolment was June 23, 2015.
Written informed consent was obtained from all participants
before study procedures.
Assessments
The primary efficacy endpoint was the change from baseline in
hair density and hair diameter within a 1-cm diameter on the
vertex at week 8, 16 and 24 assessed by trichoscopy, photograph-
ing with a Folliscopeâ and measuring with Folliscope 2.8 soft-
ware (LeadM Corporation, Seoul, Korea). For repeated and
accurate measurements, the precise location on the scalp, where
the hair was measured over time, was determined by a combina-
tion of two techniques. The measurement area was initially
located using a flexible clear plastic sheet with 1 cm diameter
hole at the centre. Two or more scalp lesions, such as nevi,
hemangiomas or seborrhoeic keratoses, were permanently
marked on the sheet as reference sites. The aforementioned area
was confirmed by the intersection point of three distances from
fixed anatomical landmarks (tip of the nose, left tragus and right
tragus).
The secondary efficacy endpoint included global photographic
assessment by investigators and patients. Global photographs of
vertex and frontal views, with hair parted in the centre and
combed away from the centre part, were taken at baseline, week
8, week 16 and week 24, using a Nikon D5000 DSLR camera
(Nikon Corporation, Tokyo, Japan) mounted on the rotating
arm of a stereotactic head-positioning device for exposure fixa-
tion. The photographs were also controlled for camera angles
and lighting. Paired (baseline and week 24) global photographs
© 2018 European Academy of Dermatology and Venereology
Topical finasteride for male AGA 2259

were evaluated by a panel of 3 dermatologists, who were blinded Table 1 Demographics and baseline characteristics
to the treatment group, based on 7-point rating scale FMX group MX group
(
3 = marked deterioration,
2 = moderate deterioration, N = 19 N = 18

1 = mild deterioration, 0 = no change, 1 = mild improve- Age, years
ment, 2 = moderate improvement, 3 = marked improvement). Mean (SD) 39.3 (11.9) 44.4 (12.5)
Patients were also requested to rate their paired global pho- Age hair loss first noticed, years
tographs with the same 7-point rating scale. Mean (SD) 32.3 (2.7) 35.1 (2.7)
Safety assessment included the recording of all adverse events, Duration of AGA, years
assessing sexual problems by a self-administered questionnaire Mean (SD) 8.1 (5.5) 10 (8)

at every visit, and laboratory testing of plasma DHT levels, as Norwood-Hamilton type, n (%)

well as the others including complete blood count, blood urea III vertex 4 (21.1) 4 (22.2)
IV 8 (42.1) 10 (55.6)
nitrogen, serum creatinine, and liver function, at baseline and
V 7 (36.8) 4 (22.2)
week 24.
Hair density (hair/cm2)
Mean (SD) 100.3 (16.2) 105 (18.4)
Statistical analyses
Hair diameter (lm)
The sample size was determined using historical data of hair
Mean (SD) 47 (10) 49 (10)
density on the vertex of men with AGA classified as Norwood- Plasma DHT level (pg/mL)
Hamilton type III–V from Ramathibodi Hospital, and based on Median 511 483
data from the previous comparative study that the mean change Minimum-maximum 63–1273 257–978
from baseline to week 24 in hair density of patients in the com-
AGA, androgenetic alopecia; DHT, dihydrotestosterone.
bined solution and minoxidil-solution groups were 4.8 and
2.9 hairs/cm2, respectively.18 To prove a difference with a 5%
significance level and 80% power, the minimum sample size was
36. Considering a dropout rate of 10%, total sample size
required was 40. group showed a significant difference (P = 0.003 and 0.04,
Statistical analysis was performed with SPSS v.18.0 (SPSS Inc., respectively). FMX was significantly superior to MX in increas-
Chicago, IL, USA). Demographic data were analysed using stan- ing of hair density at week 16 and 24, as well as in increasing of
dard descriptive statistics. Differences of changes from baseline hair diameter at week 24 (all P < 0.05; Fig. 1). The mean change
in hair density and hair diameter between treatment groups were from baseline in total hair density at week 24 was
evaluated by repeated measures analysis of variance (ANOVA), fol- 61.84  15.65 hairs/cm2 in the FMX group and
lowed by Fisher’s protected least significant difference test. Dif- 34.88  10.24 hairs/cm2 in the MX group, with an amount of
ferences in global assessment scores were measured using chi- superiority at about 27 hairs/cm2. The mean change from base-
square test. Wilcoxon rank-sum test was used to compare the line in hair diameter at week 24 was 17  5.24 lm in the FMX
change from baseline of DHT levels between treatment groups. group and 13  4.15 lm in the MX group, with an amount of
P-value <0.05 was considered statistically significant. superiority at 4 lm.

Results Global photographic assessment by investigators There was

Among 40 men with AGA enrolled into the study (20 men in
each treatment group), 37 participants (92.5%) completed the
study. One participant in the FMX arm dropped out after the
first visit for unknown reasons while two participants in the MX
arm dropped out after 8 weeks due to the inconvenience of
methods. Analyses of demographics and efficacy were performed
with the intention-to-treat population, whereas the per-protocol
population was used in the analysis of safety data. Demographics
and baseline characteristics were similar between treatment
groups (Table 1).
Efficacy
Hair density and hair diameter Changes from baseline to week
24 in hair density and hair diameter between FMX and MX
substantial agreement on individual scores rated by a panel
of 3 dermatologists (Fleiss’ j = 0.62). FMX showed signifi-
cant superiority over MX in promoting hair growth at week
24 [P = 0.026; Fig. 2(a)]. About two-thirds of FMX-treated
subjects, accounting for 63.1%, were rated as showing
marked improvement, compared to 22.2% of MX-treated
subjects.
Global photographic assessment by patients FMX also
showed significant superiority over MX in promoting hair
growth at week 24 [P = 0.032; Fig. 2(b)]. Similarly, 52.6% of
FMX-treated subjects were rated as showing marked
improvement, compared to 16.7% of MX-treated subjects.
Global and trichoscopic photographs taken at baseline and week
24 are provided in Figures 3 and 4.

JEADV 2018, 32, 2257–2263 © 2018 European Academy of Dermatology and Venereology
2260 Suchonwanit et al.

(a) Finasteride + minoxidil (a)

14 Finasteride + minoxidil
Mean change from baseline in 70 Minoxidil
**
61.84 Minoxidil 12
12

Number of subjects
60
hair density (hairs/cm2)
10
10
50 *
42.84 8
40 6
6
30 27 34.88 4 4
4
26.05
20 2 1
19.11
10 0
Deterioration/ Mild Moderate Marked
No change improvement improvement improvement
0
Global photographic assessment by investigators
16

24
0

8
k

k (b)
ee

ee

ee

ee
W

(b) 12 Finasteride + minoxidil

20 Minoxidil 10
10

Number of subjects
†
Finasteride + minoxidil
17
Mean change from baseline

Minoxidil 8
16 8 7 7
in hair diameter (µm)

6
12 11 13
4 3
2
8 9 2
6

6 0 Deterioration/ Mild Moderate Marked

4
No change improvement improvement improvement

Global photographic assessment by patients

0
16

24
0

8
k

k
ee

ee

ee

ee

Figure 2 Global photographic assessment based on paired glo-

W

bal photographs of the vertex and frontal views from baseline to

Figure 1 The mean change from baseline in (a) hair density and
(b) hair diameter at week 8, week 16 and week 24 of topical solu-
tion of 0.25% finasteride admixed with 3% minoxidil and 3%
minoxidil solution; *P = 0.002, **P = 0.003, †P = 0.034.
Safety
There were neither serious adverse events nor sexual problems
reported in both groups. One patient in the MX group com-
plained of headache, possibly related to study medication. A dry
and flaky scalp was developed in three patients and two patients
in the FMX and MX group, respectively. Two patients in each
group also experienced scalp pruritus. All adverse effects were
rated mild in severity, and there were no differences between
treatment groups. The median per cent decrease from baseline
in plasma DHT levels at week 24 was 5.7% in the FMX group
and 7.4% in the MX group, without a significant difference
between groups (P = 0.92; Table 2).
Discussion
Androgenetic alopecia is one of common hair disorders with a
multifactorial aetiology. Predisposition to the disease depends
mainly on genetics, and the pattern is most likely polygenic inher-
itance. Among hormonal factors, DHT seems to play a major
causative role. An excess of DHT conversion in the hair follicles is
suspected to cause hair miniaturization in male patients with
AGA. It was shown that bald skin from the scalp contained a
week 24 by (a) investigators and (b) patients.
higher amount of DHT than hair-bearing skin in men with
AGA.2,3 Besides, patients with 5a-reductase type 2 deficiency,
who have no ability to converse testosterone to DHT properly, do
not experience AGA in their life.21 The current treatment of male
AGA hence aims to inhibit this conversion at the tissue site.
Despite the clinically proven efficacy in treating male AGA of
low-dose finasteride, a competitive inhibitor of 5a-reductase,
several adverse effects have been reported, including loss of
libido, erectile dysfunction, gynaecomastia, male breast cancer
and depression. These drawbacks are believed to be a conse-
quence of DHT reduction in the other tissues expressing 5a-
reductase. Multiple randomized controlled trials demonstrate
low incidence of these adverse effects with often resolving after
drug cessation.4–7 However, persistent sexual dysfunction con-
tinues to be mentioned in case reports and uncontrolled stud-
ies.22–24 A meta-analysis highlights that 34 clinical trials of
finasteride for AGA had no adequate safety reporting.25 It is sug-
gesting that adverse effects of finasteride use are possibly
underdetected. Another analysis of postmarketing database in
the United States also indicates an increase in reports of finas-
teride-associated sexual dysfunction, regardless of dosage, age or
duration of treatment.26 Therefore, topical finasteride seems to
provide hope for directly acting on the target hair follicles as well
as reducing undesirable outcomes.

JEADV 2018, 32, 2257–2263 © 2018 European Academy of Dermatology and Venereology
Topical finasteride for male AGA
Figure 3 Baseline and week 24 global photographs of patients treated with topical solution of 0.25% finasteride admixed with 3%
minoxidil, who were rated as showing marked improvement.
The efficacy of topical finasteride in male AGA has been
reported in previously published studies. In 1997, Mazzarella
et al.13 firstly showed its benefits in reducing hair fall with
0.005% finasteride solution among patients with AGA. Other
two following studies using 0.1% and 0.5% finasteride solution
also revealed superior efficacy to placebo.14,15 Later, a topical gel
of 1% finasteride was compared to finasteride 1 mg daily in a
randomized controlled clinical trial of 38 male patients with
AGA over a 6-month period. Therapeutic response was not sig-
nificantly different between both groups at the fifth month, in
terms of increasing in terminal hair count and reducing in size
of alopecia. However, during the second to the fourth month,
the tablet showed a better response to the gel. One patient from
the gel group developed scalp erythema while one patient from
the tablet group complained of decreased libido.16 A recent
review of finasteride for topical use in AGA also demonstrated
its promising results.27
The synergistic effect of oral finasteride and topical minoxidil
in treating male AGA has been established; nevertheless, there
have been no long-term studies confirming this benefit. The
exact mechanism of minoxidil on hair growth is still unclear. It
is probably by an action of direct arteriolar dilatation bringing
about increased cutaneous blood flow, as well as enhanced levels
of oxygen, nutrients and growth factors to the follicles.28 There
JEADV 2018, 32, 2257–2263
2261
was also a trend towards superior efficacy of combined solutions
of 0.1% finasteride admixed with 3% or 5% minoxidil over the
solutions of minoxidil alone, in promoting hair growth among
male patients with AGA.17,18 As noted, 0.25% finasteride solu-
tion appears to be an optimal concentration from viewpoints of
efficacy and safety. A new topical formulation of 0.25% finas-
teride admixed with 3% minoxidil, FMX solution, was then cho-
sen to study.
Results of our study revealed that FMX solution provided a
good response in the treatment of male AGA over 6 months. It
established significant superiority over 3% minoxidil solution, in
terms of increases in hair density and hair diameter, as well as
improvements on global photographic assessment by both inves-
tigators and patients. The difference in hair density between
groups was significant since the fourth month of treatment. It
was noted that about 90% of FMX-treated patients experienced
moderate to marked improvement. Moreover, almost 60% of
patients treated with FMX solution were rated as marked
improvement, compared to about 20% of patients treated with
3% minoxidil solution. Regarding adverse effects, among FMX-
treated patients, there were no systemic adverse events or any
sexual dysfunction reported. Only mild local reactions were
described, including scaly scalp and pruritus, with no differences
from the minoxidil alone group.
© 2018 European Academy of Dermatology and Venereology
2262
Figure 4 Paired trichoscopic photographs taken at baseline and
week 24 of (a) a patient treated with topical solution of 0.25%
finasteride admixed with 3% minoxidil and (b) a patient treated with
3% minoxidil solution.
FMX solution decreased plasma DHT levels by approximately
5% at the sixth month. Most of circular DHT in men comes
from the peripheral conversion of testosterone and probably
reflects the production rate of DHT in the target tissues.29 For
that reason, the minimal effect of FMX solution on plasma DHT
reduction might infer a relatively normal conversion rate at the
other peripheral sites, with appearing less vulnerable to develop
systemic adverse effects. The impact on plasma DHT of 0.25%
finasteride solution in our study is rather different from the pre-
vious study, which resulted in a 60–70% reduction at
1 week.19,20 The reason might be a difference in the evaluation
period after treatment (1 week and 6 months) or dissimilar sol-
vents and bases of the solution possibly leading to differences in
systemic drug absorption.
As oral finasteride is believed to cause genital defects in the
male fetus, and it is not clear how much systemic absorption
takes place when finasteride is applied topically, pregnant and
childbearing women should be advised not to use finasteride
solutions. Potential risks associated with releases of pharmaceu-
ticals into the environment have become an increasingly impor-
tant issue. In contrast, little is known regarding the amount
released and ecotoxicological effects of pharmaceuticals on
human and animals. Finasteride also has a potential to disrupt
endocrine systems of exposed animals, in particular causing a
reduction in their androgen signalling.30,31 Even though the cur-
rent use of finasteride has been predicted to present an insignifi-
cant risk to the environment, as its oral forms are extensively
JEADV 2018, 32, 2257–2263
Suchonwanit et al.
Table 2 Plasma dihydrotestosterone levels in participants
DHT levels (pg/mL) FMX group median MX group median
(range) (range)
Baseline 511 (63 to 1273) 483 (257 to 978)
Week 24 526 (25 to 1600) 456 (271 to 1189)
Difference
26 (
752 to 915)
38 (
980 to 387)
DHT, dihydrotestosterone.
metabolized within the liver, when topical applications are intro-
duced, there might be a greater chance of environmental con-
tamination. The release of unprocessed finasteride residues into
the environment should become a major concern due to its high
resistance to biodegradation and high accumulation in adipose
tissue of aquatic organisms.32 Unused finasteride solutions
should not be thrown in the trash, poured down the drain or
flushed down the toilet. The best way to dispose is transferring
to authorized collectors, which later access to medical waste dis-
posal units. As unabsorbed portions of finasteride might be
flushed down the drain when being washed off, household
wastewater should be effectively treated before releasing into
aquatic ecosystems. Pharmacokinetic studies on the rate of per-
cutaneous absorption of finasteride should be further performed
not only for maximizing drug absorption but also for minimiz-
ing the release of active residues into the environment.
The limitations of this study were no long-term follow-up
data, and no evaluation of scalp DHT levels. In addition to hair
density and hair diameter, other trichoscopic parameters,
including the proportion of miniaturized hairs, proportion of
follicular units with perifollicular hyperpigmentation, and aver-
age number of yellow dots, could be used in monitoring treat-
ment efficacy in the further study. In conclusion, FMX solution
yielded a better therapeutic efficacy over 3% minoxidil solution
in treating male AGA over 6-month period. The treatment with
FMX solution was also well tolerated. This new solution might
be an alternative treatment option for male patients with AGA,
in particular ones who are concerned about complications from
oral finasteride.
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