Research

JAMA Dermatology | Original Investigation

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

A Randomized Clinical Trial
Mariana Alvares Penha, MD, MSc; Hélio Amante Miot, MD, PhD; Michal Kasprzak, PhD; Paulo Müller Ramos, MD, PhD

Visual Abstract
IMPORTANCE There has been increased interest in low-dose oral minoxidil for androgenetic Supplemental content
alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be
evaluated in comparative therapeutic trials.

OBJECTIVE To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs
twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA.

DESIGN, SETTING, AND PARTICIPANTS This double-blind, placebo-controlled randomized

clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged
18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and
randomized. Data were collected from January to December 2021, and data were analyzed
from September 2022 to February 2023.

INTERVENTIONS Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily
and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for
24 weeks.

MAIN OUTCOMES AND MEASURES The primary outcome was change in terminal hair density
on the frontal and vertex regions of the scalp. The secondary outcomes were change in total
hair density and photographic evaluation.

RESULTS Among 90 enrolled participants, 68 completed the study; of these, the mean (SD)
age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group
and 35 in the topical treatment group. Both groups were homogenous in terms of
demographic data and AGA severity. For the frontal area, the mean change from baseline to
week 24 between groups was 3.1 hairs per cm2 (95% CI, −18.2 to 21.5; P = .27) for terminal
hair density and 2.6 hairs per cm2 (95% CI, −10.3 to 15.8; P = .32) for total hair density. For the
vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, −0.3
to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, −12.5 to 23.5; P = .32) for
total hair density. According to the photographic analysis, oral minoxidil was superior to
topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but not on the frontal scalp
(12%; 95% CI, −12 to 36; P = .24). The most common adverse effects in the oral minoxidil
group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]).

CONCLUSIONS AND RELEVANCE In this study, oral minoxidil, 5 mg, once per day for 24 weeks
did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA.

TRIAL REGISTRATION Brazilian Registry of Clinical Trials Identifier: RBR-252w9r

Author Affiliations: Department of

Dermatology, Faculty of Medicine of
Botucatu, São Paulo State University
(UNESP), Botucatu, Brazil (Penha,
Miot, Müller Ramos); TrichoLAB
GmbH, Warsaw, Poland (Kasprzak).
Corresponding Author: Paulo Müller
Ramos, MD, PhD, Department of
Dermatology, Faculty of Medicine of
Botucatu, São Paulo State University
(UNESP), Av Prof Mário Rubens
Guimarães Montenegro, s/n, Rubião
Júnior, Botucatu, São Paulo
JAMA Dermatol. 2024;160(6):600-605. doi:10.1001/jamadermatol.2024.0284 18618-970, Brazil (dermato.paulo@
Published online April 10, 2024. gmail.com).

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 Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia Original Investigation Research

A
ndrogenetic alopecia (AGA) is the main cause of hair
loss among men.1 It occurs due to progressive minia- Key Points
turization of the hair follicles and shortening of the
Question Is oral minoxidil effective in treating androgenetic
anagen phase.2 AGA causes low self-esteem and negatively alopecia in men compared with topical minoxidil, 5%?
affects the quality of life.3
Findings In this double-blind, placebo-controlled randomized
To our knowledge, oral finasteride and topical minoxidil
clinical trial including 90 men with androgenetic alopecia, daily
are the only medications approved by the US Food and Drug
oral minoxidil, 5 mg, was well tolerated and did not demonstrate
Administration (FDA) for the treatment of male AGA.4 Al- superiority over topical minoxidil, 5%, in men with androgenetic
though proven to be effective, these medications pose some alopecia after 24 weeks of treatment.
clinical challenges. Many patients are reluctant to use finas-
Meaning Low-dose oral minoxidil (5 mg per day) had similar
teride due to the possibility of adverse sexual effects.5 Topi-
efficacy to topical minoxidil, 5%, for men with androgenetic
cal minoxidil, on the other hand, can cause changes to hair tex- alopecia and can be an option for patients who prefer oral therapy
ture, hair combing problems, and scalp irritation that may lead or are intolerant to topical treatment.
to low compliance.6
There has been increased interest worldwide in low-dose
oral minoxidil, 0.25 to 5 mg, per day as an alternative therapy The participants were sequentially allocated, and treat-
for AGA.7 It has already been evaluated in retrospective and ment packages were distributed in brown, opaque, sealed en-
noncomparative prospective clinical studies, but to our knowl- velopes randomly numbered in blocks generated by a com-
edge, there are no comparative therapeutic trials of low-dose puterized system operated by a researcher not involved in
oral minoxidil for male AGA.4 patient evaluation (H. A. M.). Participants, investigators, and
This double-blind, placebo-controlled randomized clini- the outcome assessors were blinded to treatment groups.
cal trial aims to compare the efficacy, safety, and tolerability Clinical and demographic data were assessed at inclu-
of oral minoxidil, 5 mg, once per day vs topical minoxidil, 5%, sion. Before treatment was started, patients underwent manual
twice per day for 24 weeks for male patients with AGA. measurement of blood pressure and heart rate. They were
evaluated again only after 24 weeks. Mean arterial pressure
was calculated using the formula (systolic arterial pres-
sure + [2 × diastolic arterial pressure])/3.
Methods Standard panoramic photographs were taken of the fron-
Patients tal, vertex, and parietal areas at 45° and 90° at baseline and
A total of 90 male patients aged 18 to 55 years consented to week 24. Two circular areas measuring 2 cm2 were shaved on
enroll in our research conducted at a specialized clinic in Presi- the frontal and vertex areas to leave 1 mm–long hair shafts.
dente Prudente, Brazil, from January to December 2021. All These areas were tattooed at the 2 points, and standardized
had AGA classified as 3V, 4V, or 5V using the Norwood- trichoscopic pictures were obtained for hair counting at base-
Hamilton scale.8 The diagnosis was established by a board- line and week 24. White hair was dyed black for better iden-
certified dermatologist (M. A. P.) based on careful clinical and tification. Moreover, patient histories and physical examina-
trichoscopic assessment. We excluded patients who under- tions were performed to evaluate edema, tachycardia,
went treatment for alopecia within the previous 6 months as palpitation, hair growth in other body parts, and any addi-
well as patients with a history of hair transplant, cardiopathy, tional adverse effects during the treatment.
nephropathy, dermatoses involving the scalp, any clinical con- The oral minoxidil group received capsules of minoxidil,
ditions causing hair loss, and hypersensitivity to minoxidil. This 5 mg, plus a placebo solution to apply to the scalp. The topi-
project was approved by the Ethics Committee of the Facul- cal minoxidil group received a topical minoxidil solution, 5%,
dade de Medicina de Botucatu, São Paulo State University plus placebo capsules. The active pharmaceutical ingredi-
(UNESP) and registered in the Brazilian Registry of Clinical ents of the oral treatment and the placebos were manufac-
Trials. All participants provided written informed consent. The tured by a compounding pharmacy and had the same excipi-
trial protocol can be found in Supplement 1, and the statisti- ents and similar visual appearance. The placebo solution
cal analysis plan can be found in Supplement 2. This study contained identical vehicles and diluents of the active solu-
followed the Consolidated Standards of Reporting Trials tion with minoxidil, 5%, and the same physical appearance and
(CONSORT) reporting guideline. sensory perception. The packaging of both active drugs and
placebos were identical.
Study Design Participants were instructed to ingest the capsule at bed-
This was a double-blind, placebo-controlled parallel random- time and apply 1 mL of the solution with dry hair twice daily
ized clinical trial conducted at a single center, with longitudi- (morning and night). They were advised the solution should
nal follow-up at 24 weeks. After signing the informed con- remain in contact with the scalp for at least 4 hours before the
sent form, participants were randomized 1:1 into 2 groups: those next wash.
who received oral minoxidil, 5 mg, once a day plus placebo The sample size calculation was based on the expecta-
solution for topical application twice daily and those who re- tion of an increase of 35 terminal hairs per cm2 in the oral mi-
ceived 1 mL of topical minoxidil, 5%, twice daily plus oral pla- noxidil group and 12 terminal hairs per cm2 in the topical mi-
cebo once a day (Figure). noxidil group, a power of 80%, an α of 5%, a 0.7 correlation

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 Research Original Investigation Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

Figure. CONSORT Flowchart

90 Men with androgenetic alopecia aged

18-55 y eligible for inclusion

90 Randomized

45 Randomized to topical minoxidil, 5%, 45 Randomized to oral minoxidil, 5 mg, once

twice per d plus oral placebo once per d per d plus topical placebo solution twice per d

10 Excluded
7 Unable to attend the 12 Excluded
appointment at 24 wk 11 Unable to attend the
1 Insomnia appointment at 24 wk
1 Hair shedding 1 Had headache
1 Eczema on the scalp

35 Included in the intention-to-treat analysis 33 Included in the intention-to-treat analysis

coefficient between measurements, and up to 30% of ex- Pearson χ2 and χ2 tests for trend. Continuous variables were
pected dropout, resulting in 45 patients for each group at 2 represented by means with SDs or medians with IQRs if indi-
evaluations (baseline and week 24).9 cated by the Shapiro-Wilk test.14
The longitudinal comparison of patient outcomes be-
Effectiveness tween times was performed using a generalized linear model
Primary Outcome of mixed effects with a robust covariance matrix (Šidák post
The primary outcome was change in terminal hair density in hoc correction) and adequate probability distribution for each
the target area. Terminal hairs (diameter of 0.06 mm or more) sample.15 Data analysis was performed with the IBM SPSS ver-
in the target area in the frontal and vertex regions were blindly sion 29.0 (IBM), and 1-tailed P values less than .05 were con-
counted at baseline and week 24. All images were processed sidered significant for the change of hair density.16
at TrichoLab, Hagen, Germany. Automated hair detection was
followed by manual correction by 3 independent operators and
inspection by qualified analyst.10,11
Results
Secondary Outcomes A total of 90 male participants with AGA were enrolled in the
Secondary outcomes included change in total hair density in study. Table 1 presents the main clinical and demographic data.
the target area, assessment of standardized clinical photo- Most participants had mild to moderate AGA, and the groups
graphs, and assessment of adverse effects, blood pressure, and were homogeneous. A total of 68 completed the study and had
heart rate. All hairs in the target area in the frontal and vertex 24-week follow-up data; of these, the mean (SD) age was 36.6
regions were blindly counted at baseline and 24 weeks using (7.8) years. There were 12 dropouts (27%) in the oral minoxi-
the same methodology described above.10,11 For assessment dil group; 11 were unable to attend appointments during the
of standardized clinical photographs, patients were in- COVID-19 pandemic, and 1 had headache. In the topical min-
structed to maintain the same hairstyle, color, length, and hair- oxidil group, 10 patients (22%) did not complete the treat-
cut throughout the study. Three dermatologists who were ment; 7 were unable to attend appointments during the
blinded to treatment compared the baseline with the week 24 COVID-19 pandemic, 1 had insomnia, 1 had persistent scalp ec-
images. They needed to achieve common agreement using a zema, and 1 had intense hair shedding. There was no differ-
5-point comparison scale (Global Aesthetic Improvement ence between the proportions of dropouts between groups.
Scale), ranging from great worsening (−2), slight worsening (−1), Table 2 presents the main outcomes of the study. At 24
no change (0), slight improvement (1), and great improve- weeks, the mean changes from baseline in terminal and total
ment (2).12 Assessment of adverse effects, blood pressure, and hair density were not different between the groups. For the
heart rate was performed at baseline and 24 weeks. frontal area, the mean change from baseline to week 24
between groups was 3.1 hairs per cm2 (95% CI, −18.2 to 21.5;
Statistical Analysis P = .27) for terminal hair density and 2.6 hairs per cm 2
All patients were analyzed using the intention-to-treat prin- (95% CI, −10.3 to 15.8; P = .32) for total hair density. For the ver-
ciple at 24 weeks regardless of treatment adherence. Patients tex area, the mean change from baseline to week 24 was 23.4
who discontinued treatment or were missing data (ie, drop- hairs per cm2 (95% CI, −0.3 to 43.0; P = .09) for terminal den-
outs) were not included in the final efficacy analysis.13 sity and 5.5 hairs per cm2 (95% CI, −12.5 to 23.5; P = .32) for
To represent categorical variables, we used counts and fre- total hair density. The percentage increase in terminal hair den-
quencies. Additionally, we calculated 95% CIs using 5000 boot- sity was 27.1% (95% CI, 6.5-47.8) higher for the oral minoxidil
strap resamplings. Their proportions were compared using group (P = .005) in the vertex and 13.1 (95% CI, −11.5 to 37.5%;

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 Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia Original Investigation Research

P = .15) in the frontal scalp. For total hair density, there was an
Table 1. Baseline Clinical and Demographic Data of 90 Men
increase of 2.1% (95% CI, −8.1 to 12.3; P = .27) in the oral min- With Androgenetic Alopecia Included in the Study
oxidil group compared with the topical minoxidil group in the
No. (%)
vertex and a decrease of 0.2% (95% CI, −8.4 to 8.0; P = .89) in
Oral minoxidil Topical minoxidil
the frontal area. Characteristic (n = 45) (n = 45)
According to the consensus of the 3 dermatologists blinded Age, mean (SD), y 37.2 (8.4) 35.9 (7.1)
to treatments, 20 of 33 in the oral minoxidil group (60%) and Phototype
17 of 36 in the topical minoxidil group (48%) had clinical im- I-II 16 (36) 11 (24)
provement in the frontal area, with no significant difference
III 20 (44) 27 (60)
between the groups (difference, 12%; 95% CI, −12 to 36; P = .24).
IV 9 (20) 7 (16)
More patients in the oral minoxidil group (23 of 33 [70%]) had
Level of education
clinical improvement in the vertex area than patients in the
Elementary school 1 (2) 0
topical minoxidil group (16 of 35 [46%]) (difference, 24%;
95% CI, 0-48; P = .04). High school 11 (24) 13 (29)

The changes in the main cardiovascular parameters (eg, Graduate school 33 (73) 32 (71)
heart rate and blood pressure) did not differ between groups Norwood-Hamilton scale grade
(Table 2). Only 3 of 45 patients (7%) in the topical minoxidil 3V 24 (53) 27 (60)
group and 1 of 45 (2%) in the oral minoxidil group discontin- 4V 16 (36) 13 (29)
ued treatment due to adverse effects (P = .61). Table 3 shows 5V 5 (11) 5 (11)
the adverse effects reported. Hypertrichosis was the main ad- BMI, mean (SD)a 27.1 (3.9) 28.1 (4.3)
verse effect reported and was more prevalent in the oral mi- HR, mean (SD), beats per min 71.6 (8.6) 70.3 (9.6)
noxidil group (22 [49%] vs 11 [25%]; P = .02). In both groups,
Blood pressure, mean (SD), mm Hg
it was generalized, well tolerated, and did not influence pa-
Systolic 123.3 (12.2) 122.2 (10.4)
tient compliance. Headache was more prevalent in the oral mi-
Diastolic 81.3 (6.6) 81.3 (6.9)
noxidil group, while local effects (itching and eczema) were
MAP, mean (SD), mm Hg 95.3 (8.0) 95.0 (7.4)
more common among those using topical minoxidil.
There was no difference between the groups regarding Abbreviations, BMI, body mass index; HR, heart rate; MAP, mean arterial pressure.
a
variation in mean arterial blood pressure over time. None of Calculated as weight in kilograms divided by height in meters squared.
the participants reported dizziness, fainting, or vertigo. Rest-
ing heart rate also showed no difference between groups. Tran- adverse effects that may be observed with 5α-reductase in-
sient hair loss was experienced during the first 2 months of hibitors, making it an attractive choice for this condition.5
treatment by 4 patients (9%) in the oral minoxidil group and To our knowledge, the only existing data to date regard-
7 (16%) in the topical minoxidil group (P = .34). ing increased hair density with oral minoxidil, 5 mg, once per
day for men with AGA comes from the noncomparative pro-
spective study by Panchaprateep and Luengarun18 who ob-
served 30 Thai patients for 24 weeks. In that study, there was
Discussion an increase in nonvellus hair density of 35.9 hairs per cm2
In this study, after 24 weeks, oral minoxidil, 5 mg, once per (23.6%) and in total hair density of 35.1 hairs per cm2 (19.2%)
day improved terminal and total hair density, although it did on the vertex region. Here, we observed a similar percentage
not show superiority compared with topical minoxidil, 5%. increase in terminal hair density on the vertex (21.6%; 95% CI,
However, in the expert photographic evaluation at the vertex 8.6-34.0) but not in total hair density (8.7%; 95% CI, 1.5-16.2).
and concerning the percentile increase of terminal hair den- The topical minoxidil group had lower-than-expected re-
sity in the vertex area, oral minoxidil therapy demonstrated sults in terminal and total hair density. Differences in results
superiority. Both treatments presented a safe profile and were among studies may be related to population or environmen-
well tolerated. tal factors, evaluation methods, lack of patient compliance, and
Oral minoxidil is a potent vasodilator approved by the FDA other reasons. Moreover, this study was carried out during the
for the treatment of hypertension, usually in doses of 10 to 40 COVID-19 pandemic, which restricted follow-up visits and pre-
mg daily. At these doses, the most common adverse effects are cluded identification of those with COVID-19 infection and pos-
hypertrichosis, tachycardia, headache, and edema. It was sible implications, like the frequent reports of infection-
first described as a therapeutic option in men with AGA in induced telogen effluvium.19 Head-to-head randomized clinical
1980.17 Since then, its topical formulation has been studied for trials are essential to compare different therapies. Despite the
AGA, having received FDA approval in 1988. Numerous expectations of the great superiority of oral minoxidil for AGA,
clinical trials have proven its effectiveness, but the challenge up to now, this modality did not prove to be incontestably
of patient adherence persists.6 superior to topical minoxidil either for men or women.
Low-dose oral minoxidil has emerged as a promising al- In a previous randomized clinical trial comparing oral mi-
ternative to topical minoxidil for the treatment of AGA in re- noxidil, 1 mg, with topical minoxidil, 5%, for female pattern
cent years. One of its main advantages is to avoid the prob- alopecia, we found no difference in hair density improve-
lems of topical therapy.7 Additionally, it does not cause sexual ment between the groups.20 However, if the outcomes of these

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 Research Original Investigation Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

Table 2. Main Outcomes of 68 Participants Who Completed the Study at Baseline at Week 24

Oral minoxidil (n = 33) Topical minoxidil (n = 35)

Measure Baseline Week 24 Baseline Week 24 Difference (95% CI)a P valueb
Density of hair, mean (SD), cm2
Frontal
Terminal 91.2 (47.6) 101.5 (54.4) 105.3 (42.2) 109.7 (49.0) 3.1 (−18.2 to 21.5) .27
Total 190.2 (61.2) 201.0 (61.4) 207.4 (63.7) 215.5 (58.9) 2.6 (−10.3 to 15.8) .32
Vertex
Terminal 96.8 (48.1) 111.4 (58.8) 134.3 (51.4) 125.4 (61.6) 23.4 (−0.3 to 43.0) .09
Total 190.3 (55.8) 201.9 (57.7) 211.6 (67.8) 216.5 (65.1) 5.5 (−12.5 to 23.5) .32
Hair density improvement, % (95% CI)
Frontal
Terminal NA 20.0 (4.8-39.9) NA 7.0 (−4.7-20.4) 13.1 (−11.5 to 37.5) .15
Total NA 7.0 (3.0-11.5) NA 6.4 (0.7-13.5) −0.2 (−8.4 to 8.0) .89
Vertex
Terminal NA 21.6 (8.6-34.0) NA −5.6 (−17.5-6.4) 27.1 (6.5 to 47.8) .005
Total NA 8.7 (1.5-16.2) NA 4.9 (0-10.8) 2.1 (−8.1 to 12.3) .27
GAIS, No. (%)
Frontal
−2 NA 1 (3) NA 0 NA
−1 NA 1 (3) NA 2 (6) NA
0 NA 11 (33) NA 16 (46) NA .24
1 NA 11 (33) NA 12 (34) NA
2 NA 9 (27) NA 5 (14) NA
Vertex
−1 NA 2 (6) NA 1 (3) NA
0 NA 8 (24) NA 18 (51) NA
.04
1 NA 16 (48) NA 14 (40) NA
2 NA 7 (21) NA 2 (6) NA
HR, mean (SD), beats per min 72.1 (8.4) 72.9 (7.6) 70.2 (9.8) 72.2 (9.5) 0.7 (−3.3 to 4.8) .72
Blood pressure, mean (SD), mm Hg
Systolic 125.1 (13.2) 123.0 (9.5) 121.4 (11.2) 118.3 (9.9) 4.7 (0.0 to 9.4) .07
Diastolic 81.8 (6.8) 80.9 (6.8) 81.1 (6.8) 79.7 (8.6) 1.2 (−2.4 to 4.8) .52
MAP, mean (SD), mm Hg 96.33 (8.4) 94.9 (7.1) 94.6 (7.5) 92.6 (8.4) 2.4 (−1.3 to 6.1) .21
b
Abbreviations: GAIS, Global Aesthetic Improvement Scale; HR, heart rate; One-tailed P value.
MAP, mean arterial pressure; NA, not applicable.
a
Based on 5000 bootstrap resamplings.

studies are taken together, they suggest a trend toward a greater

Table 3. Main Adverse Effects
improvement in the oral minoxidil group. Perhaps this
No. (%) superiority can only be evidenced in larger studies or with a
Oral minoxidil Topical minoxidil longer follow-up time.
Adverse effect (n = 45) (n = 45) P value
The adverse effects of low-dose oral minoxidil were mild
Hypertrichosis 22 (49) 11 (25) .02
and well tolerated, and only 1 patient stopped the medication
Headache 6 (14) 1 (2) .046
due to headache. Hypertrichosis was the most commonly re-
Itching on the scalp 1 (2) 5 (11) .09
ported adverse effect and was more prevalent in the oral mi-
Nightmares 1 (2) 2 (5) .58 noxidil group. There were no significant changes in heart rate
Scalp eczema 1 (2) 7 (16) .02 and blood pressure in the oral minoxidil group, endorsing its
Shedding 4 (9) 7 (16) .34 negligible hypotensive potential for healthy individuals.21 Large
Appetite increase 0 1 (2) .33 case series have reinforced the safety of low-dose oral
Insomnia 1 (2) 2 (5) .58 minoxidil.22,23
Lower limb edema 1 (2) 0 .33
Furthermore, it is known that minoxidil may cause tran-
sient hair loss in the first 2 months of treatment due to the early
Abdominal pain 1 (2) 0 .33
release of hairs in the telogen phase (premature teloptosis). This
Pain in lower limbs 1 (2) 0 .33
reaction was previously described in up to 17% of patients using

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 Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia Original Investigation Research

topical minoxidil.24 In our study, this happened in 16% of pa- compare different doses of oral minoxidil as well as its use with
tients in the topical minoxidil group and only 9% in the oral topical minoxidil or 5α-reductase inhibitors.
minoxidil group. It is crucial to inform patients about its tran-
sient and self-limited nature to prevent early treatment inter-
ruption.
Conclusions
Limitations In conclusion, oral minoxidil, 5 mg, once per day did not dem-
Our study has limitations, including its monocentric format, onstrate superiority over topical minoxidil, 5%, twice per day in
the relatively small sample size, and the substantial rates of the treatment of male AGA after 24 weeks. Nevertheless, the over-
follow-up loss. Nevertheless, to our knowledge, this was the all photographic improvement in the vertex was superior in the
first double-blind randomized clinical trial to evaluate the ef- oral minoxidil group. Low-dose oral minoxidil has shown to be
ficacy of oral vs topical minoxidil for men with AGA. Further well tolerated and, therefore, is an option for patients who prefer
larger clinical trials with longer follow-up times are needed to oral therapy or are intolerant to topical treatment.

ARTICLE INFORMATION 3. Cash TF. The psychosocial consequences of using SPSS. Nat Protoc. 2016;11(6):1112-1129. doi:10.
Accepted for Publication: January 29, 2024. androgenetic alopecia: a review of the research 1038/nprot.2016.048
literature. Br J Dermatol. 1999;141(3):398-405. 16. Miola AC, Miot HA. P value and effect-size in
Published Online: April 10, 2024. doi:10.1046/j.1365-2133.1999.03030.x
doi:10.1001/jamadermatol.2024.0284 clinical and experimental studies. J Vasc Bras. 2021;
4. Gupta AK, Venkataraman M, Talukder M, 20:e20210038. doi:10.1590/1677-5449.210038
Author Contributions: Dr Penha had full access to Bamimore MA. Relative efficacy of minoxidil and
all of the data in the study and takes responsibility 17. Zappacosta AR. Reversal of baldness in patient
the 5-α reductase inhibitors in androgenetic receiving minoxidil for hypertension. N Engl J Med.
for the integrity of the data and the accuracy of the alopecia treatment of male patients: a network
data analysis. 1980;303(25):1480-1481. doi:10.1056/
meta-analysis. JAMA Dermatol. 2022;158(3):266-274. NEJM198012183032516
Concept and design: Penha, Miot, Müller Ramos. doi:10.1001/jamadermatol.2021.5743
Acquisition, analysis, or interpretation of data: 18. Panchaprateep R, Lueangarun S. Efficacy and
Penha, Kasprzak, Müller Ramos. 5. Pereira AFJR, Coelho TOA. Post-finasteride safety of oral minoxidil 5 mg once daily in the
Drafting of the manuscript: Penha, Miot, syndrome. An Bras Dermatol. 2020;95(3):271-277. treatment of male patients with androgenetic
Müller Ramos. doi:10.1016/j.abd.2020.02.001 alopecia: an open-label and global photographic
Critical review of the manuscript for important 6. Mapar MA, Omidian M. Is topical minoxidil assessment. Dermatol Ther (Heidelb). 2020;10(6):
intellectual content: All authors. solution effective on androgenetic alopecia in 1345-1357. doi:10.1007/s13555-020-00448-x
Statistical analysis: Miot, Kasprzak, Müller Ramos. routine daily practice? J Dermatolog Treat. 2007;18 19. Müller-Ramos P, Ianhez M, Silva de Castro CC,
Obtained funding: Penha, Miot. (5):268-270. doi:10.1080/09546630701383727 Talhari C, Criado PR, Amante Miot H.
Administrative, technical, or material support: 7. Muller Ramos P. Oral minoxidil for hair loss: Post—COVID-19 hair loss: prevalence and
Penha, Miot, Müller Ramos. update and perspectives. Hair Transplant Forum Int. associated factors among 5,891 patients. Int J
Supervision: Penha, Miot, Müller Ramos. 2023;33:93-94. doi:10.33589/33.3.93 Dermatol. 2022;61(5):e162-e164. doi:10.1111/ijd.16041
Conflict of Interest Disclosures: Dr Penha 8. Wirya CT, Wu W, Wu K. Classification of 20. Ramos PM, Sinclair RD, Kasprzak M, Miot HA.
reported grants from Brazilian Dermatology Society male-pattern hair loss. Int J Trichology. 2017;9(3): Minoxidil 1 mg oral versus minoxidil 5% topical
Support Fund (FUNADERM) during the conduct of 95-100. doi:10.4103/ijt.ijt_46_17 solution for the treatment of female-pattern hair
the study. No other disclosures were reported. loss: a randomized clinical trial. J Am Acad Dermatol.
9. Overall JE, Doyle SR. Estimating sample sizes for
Funding/Support: This study was supported by the repeated measurement designs. Control Clin Trials. 2020;82(1):252-253. doi:10.1016/j.jaad.2019.08.060
Brazilian Dermatology Society Support Fund 1994;15(2):100-123. doi:10.1016/0197-2456(94) 21. Sanabria BD, Palmegiani E, Seron AF,
(FUNADERM). 90015-9 Perdomo YC, Miot HA, Müller Ramos P. Prospective
Role of the Funder/Sponsor: The funder had no 10. Kasprzak M, Sicińska J, Tosti A. Follicular map: cardiovascular evaluation with 24-hour Holter and
role in the design and conduct of the study; a novel approach to quantitative trichoscopy. Skin 24-hour ambulatory blood pressure monitoring in
collection, management, analysis, and Appendage Disord. 2019;5(4):216-220. doi:10.1159/ men using 5-mg oral minoxidil for androgenetic
interpretation of the data; preparation, review, or 000497193 alopecia. J Am Acad Dermatol. 2023;88(2):436-437.
approval of the manuscript; and decision to submit doi:10.1016/j.jaad.2022.05.026
the manuscript for publication. 11. Bokhari L, Cottle P, Grimalt R, et al. Efficiency of
hair detection in hair-to-hair matched trichoscopy. 22. Sanabria B, Vanzela TN, Miot HA, Müller Ramos P.
Data Sharing Statement: See Supplement 3. Skin Appendage Disord. 2022;8(5):382-388. doi:10. Adverse effects of low-dose oral minoxidil for
Additional Contributions: We thank the 1159/000524345 androgenetic alopecia in 435 patients. J Am Acad
Department of Dermatology and Radiotherapy of Dermatol. 2021;84(4):1175-1178. doi:10.1016/j.jaad.
12. Narins RS, Brandt F, Leyden J, Lorenc ZP, 2020.11.035
the Faculdade de Medicina de Botucatu, São Paulo Rubin M, Smith S. A randomized, double-blind,
State University (UNESP), who supported and multicenter comparison of the efficacy and 23. Vañó-Galván S, Pirmez R, Hermosa-Gelbard A,
allowed the study, and the Brazilian Dermatology tolerability of Restylane versus Zyplast for the et al. Safety of low-dose oral minoxidil for hair loss:
Society Support Fund (FUNADERM), which correction of nasolabial folds. Dermatol Surg. 2003; a multicenter study of 1404 patients. J Am Acad
financed the work. 29(6):588-595. Dermatol. 2021;84(6):1644-1651. doi:10.1016/j.jaad.
2021.02.054
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