International Journal of Research in Dermatology

Rai PB et al. Int J Res Dermatol. 2018 Aug;4(3):386-390

http://www.ijord.com

DOI: http://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20183163
Original Research Article

Comparing the therapeutic efficacy of topical minoxidil and finasteride

with topical minoxidil and oral finasteride in androgenetic alopecia:
a randomized trial
Priyam Bhaskar Rai, Pragya Khushwaha*, Nitish Jain, Swati Gupta

Department of Dermatology, Venereology and Leprosy, Muzaffarnagar Medical College and Hospital, CCS
University, Muzaffarnagar, Uttar Pradesh, India

Received: 13 April 2018

Accepted: 15 May 2018

*Correspondence:
Dr. Pragya Khushwaha,
E-mail: dr.pragya28@gmail.com

Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: There is an increased interest in the development and use of topical finasteride for treating androgenic
alopecia (AGA) due to growing evidence of side effects from oral finasteride. In this study we aimed to compare the
treatment outcomes of topical 5% minoxidil with 0.1% finasteride and topical 5% minoxidil with oral 1 mg
finasteride.
Methods: 50 patients of stage III and IV of Hamilton-Norwood scale were randomly assigned to either Group A
receiving topical 5% minoxidil and oral finasteride 1 mg and Group B receiving topical 5% minoxidil and topical
0.1% finasteride. After taking uninterrupted treatment for 12 months, patients were assessed for hair regrowth and
maintenance using global photography and trichoscopy and compared with baseline parameters. Patients in both the
groups were assessed for any adverse effects as well.
Results: At baseline, patients in both the treatment groups were similar with respect to their age at the time of
presentation, family history of hair loss and Hamilton Norwood scale. In group A, three discontinued treatment and of
the rest 65% maintained a good hair density and reduced hairfall. In group B, five discontinued treatment, of the rest
83% patients demonstrated good improvement in hair density (p<0.05).
Conclusions: The results of this study strongly support the use of topical finasteride in combination with topical 5%
minoxidil for AGA and this may obviate the need of taking long term oral finasteride.

Keywords: Androgenic alopecia, Finasteride, Minoxidil, Outcomes

INTRODUCTION depigmented hairs (vellus).2 Scalp biopsy on histological

examination reveals that perifollicular lymphocytic
Androgenic alopecia, commonly referred to as male- infiltration is very common and culminates in fibrosis of
pattern hair loss in men or as female-pattern hair loss in the follicle. The mechanism explaining the microscopic
women, affects at least half of all men by the age of 50 follicular inflammation resulting in fibrosis has been
years, and more later in life.1 This androgen-dependent poorly understood.
hair loss is heritable and occurs in a specific pattern. It
has been hypothesised that the genetically predisposed Minoxidil, developed as an anti-hypertensive agent,
hair follicles undergo miniaturization after being promotes hair growth through increasing the duration of
stimulated by androgens, which result in gradual anagen.3 Finasteride is a competitive inhibitor of type 2
replacement of large and pigmented hairs by thin and 5- reductase and inhibits the conversion of testosterone

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 Rai PB et al. Int J Res Dermatol. 2018 Aug;4(3):386-390

to dihydrotestosterone (DHT).4 DHT, by binding to the dermatological conditions; patients with alopecia other
androgen receptors in the dermal papillae of the hair than androgenetic alopecia.
follicles, causes miniaturization of follicles, reduced
duration of anagen phase and decreased anagen to telogen Interventions
ratio. This presents clinically as decreased hair density.5
Though, oral finasteride is well tolerated, numerous Patients were randomized into two groups. Group A
preclinical and clinical studies have reported significant received topical 5% minoxidil and oral finasteride 1 mg.
sexual adverse effects like decreased libido, erectile Group B received topical 5% minoxidil and topical 0.1%
dysfunction, ejaculation disorders, and orgasm disorders finasteride. Examined patients were blinded to the type of
etc.6,7 Given the concerning efficacy and side-effects of treatment being given to the patient. The patients were
oral finasteride, there is an interest in the development of assigned to either of the two groups using the random
a better tolerated topical formulation. Since, hair follicles number method with 1:1 allocation ratio.
widely home in 5α-reductase, topical formulations of
finasteride in comparison to its oral formulations are Outcomes
expected to potentially reduce its systemic adverse
effects. In this study we aimed to compare the treatment Patients in both the groups received treatment for 12
outcomes of topical 5% minoxidil with 0.1% finasteride months. Primary endpoint was photographic score at the
with topical 5% minoxidil with oral 1 mg finasteride. end of 12 months from baseline. Standardized digital
photographs of the frontal and parietal region were taken
METHODS every three months with the patient’s head in a similar
position to ensure consistency of photography. Secondary
Study design endpoint was trichoscopy examination done by two
doctors blinded to the treatment. Quality of life
An interventional, prospective, double blinded assessment was done according to the male androgenetic
randomized clinical trial. alopecia quality-of-life (QoL) Questionnaire.8 Safety
evaluations were done on every visit by asking patients
Participants about any adverse event related to medication. Routine
investigations were ordered as and when required.
Patients in the age group of 18-45 years whose primary
complaint of androgenic alopecia and had stage III and Assessment criteria
IV of Hamilton-Norwood scale were included in the
study. The diagnosis of androgenic alopecia was made  Photographic assessment at every visit.
based on the history given by the patient and the clinical  Trichoscan (measurement of hair density and
examination. All patients taking treatment for androgenic diameter).
alopecia from the outpatient Department of Dermatology,  Patients overall satisfaction at the end of treatment.
Venerology and Leprosy at Muzaffarnagar Medical
College, Muzaffarnagar (UP) from March 2017 till Statistical analysis
March 2018 were included in the study. The patients
were in good general health with no evidence of any Using SPSS version 23 treatment outcomes were
major systemic disease. We excluded patients who were compared using the chi square or Fisher’s exact test. P
known to be hypersensitive to minoxidil or finasteride or value less than 0.05 was considered statistically
were using other therapies for restoring hair or taking any significant.
other systemic medications (like steroids, cytotoxic drugs
etc.). Informed written consent was taken from all the RESULTS
patients enrolled after explaining study drugs, its benefits
and side effects and further approval from Institutional During the study period, 50 men with androgenic
Ethical Committee was obtained. alopecia were enrolled and were allocated to the
treatment arms. The age of the patients ranged from 18 to
Inclusion criteria 45 years, with an average of 29.4±3.62 years. At baseline,
patients in both the treatment groups were similar with
We included patients who were not taking any treatment respect to their age at the time of presentation, age when
from last 3 months; patients of age group 18-45 years; hair loss began, family history of hair loss and Hamilton
patients who will give written informed consent; patients Norwood scale (Table 1). In Group A three patients
with androgenetic alopecia stage III-IV Hamilton- discontinued treatment and the remaining 22 patients who
Norwood classification in male. received an uninterrupted treatment, 14 patients’ hair
density was moderately maintained, as shown in Figure 1.
Exclusion criteria 5 patients in Group B discontinued treatment, and of the
remaining patients 20 demonstrated good hair growth and
Exclusion criteria were below 18 years and more than 45 maintenance. The rate of favourable treatment outcome
years; androgenic alopecia associated with other was slightly higher in receiving topical finasteride (Group
B) (p value less than 0.05). The findings of digital

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 Rai PB et al. Int J Res Dermatol. 2018 Aug;4(3):386-390

photography and trichoscopy are as shown in Figure 2.

Comaprison of clinical improvement
Adverse events encountered in both the groups are shown
in Table 2, most interesting side effects of oral finasteride 120%
in our patients facial edema (3 patients) and dryness of

Percentage of patients
100%
mouth (5 patients). Mean quality of life was comparable 17%
in both groups at baseline (Table 3) (p=0.72), but it was 80% 35%
significantly higher in patients of Group A as compared No clinical
60%
to patients of Group B at final follow up (46.27 vs. 40.53; improvement seen
p<0.05). At the end of study period, six cases in Group A 40% 83%
65% Clinical
and only one patient in Group B were labelled as non- 20% improvement seen
responders to the treatment (Table 4).
0%
Table 1: Baseline characteristics of the patients Group A Group B
included in the study. Treatment groups

Group A Group B
Number of patients 25 25 Figure 1: Bar graph comparing the treatment
Age at the time of outcomes in the two groups.
28.5±4.4 29.2±4.9 Group A: Topical 5% minoxidil + Oral finasteride 1 mg; Group
presentation to hospital
Age when hair loss began 23.2±5.1 24.6±5.3 B: Topical 5% minoxidil + Topical finasteride 0.1%; P value
Family history of hair loss 18 17 using chi square less than 0.05.
Hamilton Norwood scale
Stage 3 14 12
Stage 4 11 13

Table 2: Side effect of finasteride in patients.

Group A Group B
Side effect
(%) (%)
Erectile dysfunction 2 (8) 0 (0)
Ejaculatory dysfunction 2 (8) 0 (0)
Anxiety/depression 4 (16) 0 (0)
Loss of libido 3 (12) 0 (0)
Facial edema 3 (12) 0 (0) A
Dryness of mouth 5 (20) 0 (0)
Itching 0 (0) 5 (20)
Erythema (over scalp) 0 (0) 4 (16)
Heaviness 0 (0) 3 (12)
Mood changes 2 (8) 0 (0)

Table 3: Comparison of improvement in quality of life

of patients.

Quality of Life Group Mean SD P value

A 38.60 11.17
Baseline 0.72
B 34.67 10.02
A 46.27 13.10 B
6 months <0.05
B 40.53 12.53
Figure 2: Digital photography and trichoscopy
Table 4: Distribution of patients as per response of comparing the treatment outcomes in the two groups:
treatment. (A) Group A patients, (B) Group B patients.
Group DISCUSSION
Response Total
A (n=22) B (n=20)
16 19 35 Oral 1 mg finasteride was FDA approved in year 1997 for
Responders
72.72% 95% 79.54% androgenetic alopecia of males. Since then no new drug
6 1 7 was introduced except dutasteride this drug has been
Non responders
27.27% 5% 0.7% approved for the treatment of scalp hair loss in South
Total 22 20 42
P value less than 0.05.

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 Rai PB et al. Int J Res Dermatol. 2018 Aug;4(3):386-390

Korea since 2009 and in Japan since 2015.9,10 It has not CONCLUSION
been approved for this indication in the United States.
Among different studies there are controversies about
Androgenetic alopecia is more of cosmetic concern rather sexual dysfunction associated with oral finasteride.
than a disease. It has tremendous psychological effect on Sexual side effects either significant or not, they do exist
young adult males. To maintain better density of hair and vary with patient’s psychological state because of
over scalp almost lifelong treatment with oral finasteride easy availability of information about everything on
is required, though side effects are thought to be very less internet and media, patients are more conscious about
with oral medication but still present. Till now various side effects of drugs. They should be properly counselled
studies have been done on oral finsteride for its efficiency and informed about the drug, especially younger ones
and side effects, but few on topical finasteride. Sintov et who are going to marry in near future. Higher therapeutic
al studied the effects of the topical base formulation for efficacy of topical minoxidil and finasteride was
finasteride and flutamide on the growth of human hair in demonstrated as compared to topical monixidil and oral
a murine transplantation model.11 According to them the finasteride for androgenic alopecia.
effective topical delivery of flutamide and finasteride for
alopecia is feasible, giving similar results to those The results of this study strongly support the use of
obtained with oral finasteride that is with no systemic topical finasteride in combination with topical minoxidil
side effects as demonstrated by Testosterone/ especially in younger ones and this may obviate the need
Dihydrotestosterone monitoring. of taking lifelong oral finasteride. Further long term
studies on larger samples at multiple centers are required
Another double blind randomized study done by to support the results of this study.
Hajheydari et al demonstrated similar effectiveness of 1%
finasteride in increasing total hair content, after 6 months Funding: No funding sources
of treatment, topical finasteride response was better in Conflict of interest: None declared
2nd, 3rd and 4th months of treatment, but equated that of Ethical approval: The study was approved by the
oral formulation of finasteride in the 5th and 6th month of institutional ethics committee
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