Randomized controlled trial on the efficacy and safety of the combination therapy of topical 0.1% finasteride − 5% Minoxidil in male androgenetic alopecia

Abstract

Current FDA-approved treatments for androgenetic alopecia (AGA) are oral finasteride and topical minoxidil. Topical finasteride offers a potential alternative with similar efficacy and fewer systemic side effects. This study evaluated the effectiveness and safety of combining topical finasteride and minoxidil for male AGA. This 12-week randomized controlled trial divided subjects into two groups which are topical finasteride 0.1%-minoxidil 5% (treatment) and topical minoxidil 5% (control) (NCT05990400, registered 2023-08-04). Hair density, hair diameter, terminal hair rate, and vellus hair rate (assessed using phototrichogram), and the occurrence of side effects (SE) was monitored at four-week intervals. Out of 40 subjects, 2 dropped out in the treatment group. Significant increases in hair density, diameter, and terminal hair rate; and decrease of vellus hair rate were observed at each visit compared to baseline, yet no differences between groups. Systemic SEs included libido reduction (control), mild erectile dysfunction, and chest pain (treatment). Common local SEs (itching, shedding, and dandruff) were similar between groups. One patient (treatment) experienced contact dermatitis. Combining topical finasteride 0.1% with topical minoxidil 5% has similar safety and effectiveness for increasing hair density and diameter in male AGA patients compared to topical minoxidil 5% after 12 weeks of observation.

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ORIGINAL PAPER
Archives of Dermatological Research (2025) 317:691
https://doi.org/10.1007/s00403-025-04216-9
2019, 31.2% of patients with hair loss were diagnosed with
AGA [2]. This condition can lead to psychological stress,
ultimately aecting a patient’s self-condence and quality
of life [3]. Androgen plays a crucial role in AGA pathogen-
esis [4, 5]. In hair follicles, testosterone is converted into
its stronger androgen receptor-anitive form, dihydrotes-
tosterone (DHT), by the enzyme 5-α reductase. Binding
of DHT to androgen receptor proteins causes alterations
in signaling between mesenchymal-derived dermal papilla
and epithelial-derived follicular cells, leading to hair follicle
miniaturization [2, 4–6].
Two FDA-approved treatments for AGA are oral nas-
teride and topical minoxidil. Oral nasteride inhibits the
conversion of testosterone to dihydrotestosterone (DHT),
promoting hair growth. However, it may have side eects
such as sexual dysfunction [7–10]. Topical minoxidil works
by increasing blood ow and promoting hair growth [7].
Combining topical nasteride and minoxidil is an option
with promising results, as shown in studies comparing it
to monotherapy [11–13]. Some studies suggest that topical
Introduction
Androgenetic alopecia (AGA), or male pattern baldness,
is a condition triggered by a vulnerability to androgen hor-
mones, causing progressive hair follicle miniaturization and
shortened hair growth phases. About 50–60% of men expe-
rience AGA after 50, rising to 80% past 70 years old [1].
According to a report from our institution between 2017 and
Lili Legiawati
lililegiawati@yahoo.com
1 Department of Dermatology and Venereology Faculty of
Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo
National Central General Hospital, Jakarta, Indonesia
2 Department of Dermatology and Venereology Faculty of
Medicine, Universitas Indonesia - Tangerang District General
Hospital, Tangerang, Indonesia
3 Clinical Epidemiology and Evidence-Based Medicine Unit
Faculty of Medicine, Universitas Indonesia - Dr. Cipto
Mangunkusumo Hospital, Jakarta, Indonesia
Abstract
Current FDA-approved treatments for androgenetic alopecia (AGA) are oral nasteride and topical minoxidil. Topical n-
asteride oers a potential alternative with similar ecacy and fewer systemic side eects. This study evaluated the eec-
tiveness and safety of combining topical nasteride and minoxidil for male AGA. This 12-week randomized controlled
trial divided subjects into two groups which are topical nasteride 0.1%-minoxidil 5% (treatment) and topical minoxidil
5% (control) (NCT05990400, registered 2023-08-04). Hair density, hair diameter, terminal hair rate, and vellus hair rate
(assessed using phototrichogram), and the occurrence of side eects (SE) was monitored at four-week intervals. Out of 40
subjects, 2 dropped out in the treatment group. Signicant increases in hair density, diameter, and terminal hair rate; and
decrease of vellus hair rate were observed at each visit compared to baseline, yet no dierences between groups. Systemic
SEs included libido reduction (control), mild erectile dysfunction, and chest pain (treatment). Common local SEs (itching,
shedding, and dandru) were similar between groups. One patient (treatment) experienced contact dermatitis. Combining
topical nasteride 0.1% with topical minoxidil 5% has similar safety and eectiveness for increasing hair density and
diameter in male AGA patients compared to topical minoxidil 5% after 12 weeks of observation.
Keywords Androgenetic alopecia · Finasteride · Minoxidil · Side eect · Topical
Received: 20 September 2024 / Revised: 12 March 2025 / Accepted: 21 March 2025
© The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2025
Randomized controlled trial on the ecacy and safety of the
combination therapy of topical 0.1% nasteride − 5% Minoxidil in
male androgenetic alopecia
Farah FaulinLubis1· LiliLegiawati1· MarthaSaulina2· Siti R.F.Saldi3
1 3
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