Efficacy and Safety of Topical 5% Azelaic Acid Solution Versus 2% Minoxidil Solution in the Treatment of Female Pattern Hair Loss

Abstract

Objective: To determine the efficacy and safety of 5% azelaic acid solution in comparison with 2% minoxidil solution in the treatment of FPHL. Materials and Methods: Twenty-six FPHL patients with Ludwig grade I or II were randomly treated with 5% azelaic acid solution or 2% minoxidil solution twice daily for 6 months. At baseline, 2, 4, and 6 months, hair density and hair shaft diameter were assessed at the targeted fixed area. At 6 months, patient and investigator assessments of hair growth were performed using a 7-point scale. Results: Hair density and hair shaft diameter in the patients treated with 5% azelaic acid and 2% minoxidil solution were significantly increased compared to the baseline in all cases and visits (P < 0.05). There were no statistically significant differences in hair density and hair shaft diameter changes between both groups (P > 0.05). Both the investigator and patient assessments were comparable between both groups at 6 months. Pruritus was the major adverse effect reported in both groups, but only mild and all could be tolerated. Conclusion: 5% Azelaic acid solution might be an effective treatment for FPHL, comparable with 2% minoxidil, and could be an alternative treatment for FPHL in minoxidil-allergic patients and pregnant women.

Full text

Volume 75, No.12: 2023 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index 887
Original Article SMJ
Kanchalit Thanomkitti, M.D., ChutiponPruksaeakanan, M.D., Chanika Subchookul, M.D., Norramon
Charoenpipatsin, M.D., Daranporn Triwongwaranat, M.D., Supenya Varothai, M.D., Rattapon uangtong,
M.D., Tanyalak Chumnumrat, B.Sc.
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ailand.
Efcacy and Safety of Topical 5% Azelaic Acid
Solution Versus 2% Minoxidil Solution in the
Treatment of Female Pattern Hair Loss
ABSTRACT
Objective: To determine the ecacy and safety of 5% azelaic acid solution in comparison with 2% minoxidil solution
in the treatment of FPHL.
Materials and Methods: Twenty-six FPHL patients with Ludwig grade I or II were randomly treated with 5% azelaic
acid solution or 2% minoxidil solution twice daily for 6 months. At baseline, 2, 4, and 6 months, hair density and
hair sha diameter were assessed at the targeted xed area. At 6 months, patient and investigator assessments of
hair growth were performed using a 7-point scale.
Results: Hair density and hair sha diameter in the patients treated with 5% azelaic acid and 2% minoxidil solution
were signicantly increased compared to the baseline in all cases and visits (P < 0.05). ere were no statistically
signicant dierences in hair density and hair sha diameter changes between both groups (P > 0.05). Both the
investigator and patient assessments were comparable between both groups at 6 months. Pruritus was the major
adverse eect reported in both groups, but only mild and all could be tolerated.
Conclusion: 5% Azelaic acid solution might be an eective treatment for FPHL, comparable with 2% minoxidil,
and could be an alternative treatment for FPHL in minoxidil-allergic patients and pregnant women.
Keywords: Androgenetic alopecia; azelaic acid; female pattern hair loss; minoxidil allergy; pregnancy (Siriraj Med
J 2023; 75: 887-893)
Corresponding author: Chutipon Pruksaeakanan
E-mail: chutipon.pruksa@gmail.com
Received 24 October 2023 Revised 16 November 2023 Accepted 16 November 2023
ORCID ID:http://orcid.org/0000-0002-3475-6741
https://doi.org/10.33192/smj.v75i12.266001
All material is licensed under terms of
the Creative Commons Attribution 4.0
International (CC-BY-NC-ND 4.0)
license unless otherwise stated.
INTRODUCTION
Androgenetic alopecia (AGA), also known as pattern
hair loss, is the most common form of nonscarring alopecia,
aecting up to 80% of men and 50% of women throughout
their lifetime.1 It is characterized by progressive hair loss
due to miniaturization of the hair follicles, resulting in
vellus transformation of the terminal hairs.2 Androgens
and genetic predisposition appear to play important roles
in etiopathogenesis.2,3 Current treatments of AGA that
are approved by the US Food and Drug Administration
(FDA) consist of oral nasteride (5α-reductase inhibitor)
in men, and topical minoxidil and low-level light therapy
(LLLT) in both men and women.4,5
Concerning female pattern hair loss (FPHL), the
treatment options are limited. Although the roles of
androgens and genetic susceptibility are less apparent than in
male AGA, oral nasteride and other antiandrogens appear
to be helpful in FPHL. However, these medications are

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o-label and restricted, especially in women of childbearing
age due to their teratogenicity and the increase in risk
of breast cancer.4 erefore, topical minoxidil is the
only FDA-approved rst-line medication for FPHL
prescribed in general practice. However, concern has
been raised in FPHL patients with pregnancy, and so
minoxidil should be avoided for pregnant women.4,6
ere have been reports of neonatal hypertrichosisand
fetal malformations (heart, brain, and vascular)related
to topical minoxidil use during pregnancy.7,8 Although
topical minoxidil usage by mothers offers no harm
to breastfed children according to expert consensus,
minoxidil-induced hypertrichosis in a breastfed infant
was recently reported.9 erefore, minoxidil should be
prescribed under supervision, especially when a substantial
maternal dosage is part of the therapy and while nursing
a premature baby.9
Elevated estrogen levels during pregnancy slow
down the hair follicles’ normal cycle of shedding. As a
result, most pregnant women with FPHL can actually
have less hair loss.10 However, some of them might also
suer from ongoing hair loss during the gestational
period, which may happen as a result of iron deciency
anemia, stopping the oral contraceptive pill, stress, or an
imbalance of essential vitamins.11,12 Further hair thinning
usually has a negative impact on quality of life and self-
esteem.
Azelaic acid is an eective topical treatment for
various dermatologic conditions, such as rosacea, acne,
and hyperpigmentation, owing to its anti-inammatory,
antioxidant, and antibacterial properties.13 In addition,
azelaic acid is also an inhibitor of 5α-reductase, which
is a key enzyme in the pathogenesis of AGA.14 A recent
study also showed that azelaic acid could protect hair
bulge cells from ultraviolet B damage via an increase in
catalase activity, and upregulate Gli1 and Gli2 expression,
which could enhance telogen to anagen transition and
promote hair growth.15 erefore, azelaic acid is believed
to be benecial in the treatment of AGA, and there
are many commercial topical preparations containing
minoxidil solutions in combination with 5% azelaic acid.
Moreover, topical azelaic acid is considered to be safe
to apply during pregnancy (pregnancy category B) and
breastfeeding.16 However to the best of our knowledge,
there has been no previous study on the ecacy of azelaic
acid topical solution monotherapy or a controlled study
comparing the ecacy of azelaic acid topical solution and
the standard treatment of AGA. us, the objective of
this study was to determine the ecacy and safety of 5%
azelaic acid solution in comparison with 2% minoxidil
solution in the treatment of FPHL.
MATERIALS AND METHODS
Study design
This prospective, randomized, double-blinded
comparative study was conducted at the Department
of Dermatology, Faculty of Medicine Siriraj Hospital,
Mahidol University. e study was approved by the
Siriraj Institutional Review Board and informed consent
was obtained from all participants. Overall, 26 FPHL
women were enrolled and randomized to receive 5%
azelaic acid topical solution or 2% minoxidil topical
solution by block randomization (1:1 allocation ratio).
e patients were instructed to apply the solution all
over their thinning scalp twice daily. e patients were
evaluated at months 0 (baseline), 2, 4, and 6.
Participants
FPHL patients aged ≥ 18 years, with a Ludwig
classication grade I or II, were recruited in the study.
ey must not have received any topical or systemic
hair loss treatment for at least 6 months prior to the
enrollment. e exclusion criteria included patients who
had other scalp, systemic, or psychiatric conditions that
could be the cause of alopecia. Pregnant or breastfeeding
women were also excluded.
Azelaic acid and minoxidil solution
Both 5% azelaic acid and 2% minoxidil solution
were formulated by the Pharmacy Department, Faculty
of Medicine Siriraj Hospital, Mahidol University. Both
solutions used the same vehicles, consisting of 50% ethyl
alcohol, 25% propylene glycol, and 25% puried water.
Outcome assessment
Hair density and diameter
On the day of enrollment, each patient was tattooed
with 4 dots forming a 1x1 cm square on the vertex area
of the scalp, using a brown cosmetic tattoo ink (Micro
Pigments, Biotouch Inc., Los Angeles, CA, USA) that
would gradually disappear aer 6 months. At each visit,
hairs in the target area were cut to approximately 1
mm in length and collected. Macrophotographs of the
target area on the scalp were taken using a dermoscopic
device (Dino-Lite DermaScope®, Dino-Lite, Naarden, the
Netherlands) and DinoCapture soware. All hairs in the
target area were manually counted and reported as the
total hair and terminal hair counts. e hair diameter at
each visit was calculated by the mean hair diameter of
ten representative hairs from the target area. Each hair
was measured using an electronic external micrometer
(RS PRO External Micrometer, RS Components Ltd.,
Corby, UK). Both the hair density and hair diameter at
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each visit of all the participants were evaluated by the
same author (C.P.), who was blinded to the treatment.
Global photographic review (GPR)
Standardized photographs were taken using a digital
camera (Digital Canon PowerShot G15, Canon Inc., Tokyo,
Japan) at baseline and 6 months. All the photographs at
baseline and 6 months were evaluated by two blinded
expert dermatologists (K.T. and D.T.) for assessing the
improvement in the patient’s global hair volume using a
7-point scale (-3 = signicant worsening; -2 = moderate
worsening; -1 = slight worsening; 0 = no change; +1 =
mild improvement; +2 = moderate improvement; +3 =
signicant improvement).
Patient’s own evaluation
Aer 6 months, patients evaluated their improvement
of FPHL compared with the baseline using a 7-point
scale, as in the GPR assessment.
Safety assessments
At every patient visit, safety evaluations of 5%
azelaic acid solution and 2% minoxidil solution were
conducted utilizing the combined information from the
history taking, physical examination, and photoimaging.
e majority of recorded adverse events were related
to scalp irritation, including erythema, itching, scaling,
and pruritus. Subjects rated the severity as none, mild,
moderate, or severe. Inspection of the returned container
of the designated preparation allowed for the assessment
of patient drug compliance.
Statistical analysis
All the data were analyzed using PASW Statistics,
version 18.0 (SPSS Inc, Chicago, IL, USA). Descriptive
statistics were demonstrated as the frequency, percentage,
mean ± standard deviation (SD), median, and range. All
the continuous data were evaluated for normality by
the Shapiro–Wilk test. e paired t-test and repeated
measured ANOVA were used to compare the mean hair
density and hair diameter of each visit. e independent
t-test was used to compare the means of the two groups.
Nonparametric data were compared using the Mann–
Whitney U test. Pearson chi-square test and Fisher’s exact
test were used to compare the categorical data between
the two groups. A P-value of <0.05 was considered to
be statistically signicant.
RESULTS
Demographic data of the patients
This trial enrolled a total of 26 FPHL patients
with a mean age of 38.7 years. At baseline, the patients’
demographics and hair loss characteristics were similar
between both treatment groups (Table 1). Most of them
had grade I hair loss severity on the basis of the Ludwig
classication.
TABLE 1. Demographic data of patients with female pattern hair loss treated with 5% azelaic acid and 2% minoxidil
topical solution.
5% Azelaic acid solution 2% Minoxidil solution P-value
(n = 13) (n = 13)
Age, y, mean (SD) 40.1 (6.6) 37.3 (4.2) 0.216
Family history of AGA, n (%) 8 (61.5) 5 (38.5) 0.239
Age of onset, y, mean (SD) 33.5 (7.9) 31.5 (6.0) 0.473
Duration of hair loss, months, median (range) 84 (5 to156) 60 (24 to 156) 0.638
Ludwig classication, n (%) 1.000
Grade I 11 (84.6) 10 (76.9)
Grade II 2 (15.4) 3 (23.1)
Baseline hair density, per cm2, mean (SD)
Total hair 139.1 (34.3) 158.1 (36.9) 0.419
Terminal hair 109.2 (31.6) 127.7 (34.2) 0.644
Baseline hair diameter, μm, mean (SD) 66.0 (7.7) 65.5 (9.3) 0.548

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Hair density and hair diameter
e hair density and hair diameter of the participants
treated with 5% azelaic acid and 2% minoxidil solution
at each follow-up visit are shown in Table 2. Compared
to the baseline, the hair density and hair diameter of
both groups signicantly increased aer two months of
treatment. ere were no signicant dierences in the
mean percentage of improvement in hair density and
diameter between both groups during six months. At
the end of the study, the hair density of the 5% azelaic
acid solution group and 2% minoxidil solution group
increased by 20.4% and 21.1%, respectively. e diameter
of the hair improved by 5.3% in the group receiving 5%
azelaic acid solution and 7.6% in the group receiving 2%
minoxidil solution.
Global photographic review
e investigators assessment of both groups at six
months were comparable. Five patients (38.5%) treated
with 5% azelaic acid solution showed a mild to moderate
improvement in their FPHL (4 mild improvement, 1
moderate improvement), compared with four patients
(30.8%) treated with 2% minoxidil solution (1 mild
improvement, 3 moderate improvement). Clinical
photographs demonstrating the treatment responses
aer a 6-month period of using 5% azelaic acid solution
and 2% minoxidil solution are shown in Fig 1 and Fig 2,
respectively.
Patient’s own assessment
Regarding the patient’s own assessment, 12 patients
(92.3%) treated with 5% azelaic acid solution reported
an improvement in their hair loss (5 mild improvement,
7 moderate improvement), while 11 patients (84.6%) treated
with 2% minoxidil solution reported an improvement (3
mild improvement, 4 moderate improvement, 4 signicant
improvement) at the end of the study.
Adverse eects
e major reported adverse eect of both 5% azelaic
acid and 2% minoxidil topical solution was pruritus,
comprising 46.2% of patients in the azelaic acid group and
23.1% in the minoxidil group (Table 3). Most patients in
both groups rated only a mild degree of pruritus, which
tended to improve over time. One patient treated with
2% minoxidil solution complained of dryness, while one
patient treated with 5% azelaic acid solution reported
scaling. No patients reported erythema, or a burning or
stinging sensation.
TABLE 2. Comparison of hair density and hair diameter at each follow-up visit aer treatment with 5% azelaic
acid and 2% minoxidil topical solution
5% Azelaic acid solution 2% Minoxidil solution
Azelaic acid
Difference in percentage
(n = 13) (n = 13) vs. of improvement
Minoxidil between both groups
P-value P-value Mean
Mean (SD)
(compared
Mean (SD)
(compared
P-value difference P-value
to baseline) to baseline)
Total hair density, per cm
2
Baseline 139.1 (34.3) 158.1 (36.9) 0.186
2 months 154.7 (37.1) 0.001 180.5 (45.9) 0.001 0.129 -2.4 0.592
4 months 161.2 (35.5) <0.001 187.0 (45.0) <0.001 0.118 -2.1 0.718
6 months 167.5 (35.0) <0.001 191.5 (39.6) <0.001 0.115 -0.4 0.947
Hair diameter, μm
Baseline 66.0 (7.7) 65.5 (9.3)
2 months 68.0 (9.3) 0.017 68.1 (8.4) 0.043 0.968 -1.5 0.475
4 months 69.4 (7.9) 0.001 69.1 (8.0) 0.010 0.939 -0.8 0.735
6 months 69.5 (7.9) <0.001 70.5 (9.3) 0.004 0.760 -2.6 0.282
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TABLE 3. Reported adverse eects from 5% azelaic acid and 2% minoxidil topical solution.
5% Azelaic acid solution 2% Minoxidil solution
(n = 13) (n = 13)
Dryness, n (%) 0 (0) 1 (7.7)
Pruritus, n (%) 6 (46.2) 3 (23.1)
Scaling, n (%) 1 (7.7) 0 (0)
Fig 1. Female pattern hair loss patients (Ludwig
grade I) who received 5% azelaic acid solution twice
daily for 6 months. Patient No. 1 (A baseline, B 6
months) and patient No. 2 (C baseline, D 6months).
Fig 2. Female pattern hair loss patients (Ludwig
grade I) who received 2% minoxidil solution twice
daily for 6 months. Patient No. 3 (A baseline, B 6
months) and patient No. 4 (C baseline, D 6 months).

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DISCUSSION
According to Stamatiadis et al.’s study, azelaic acid
was proved to be a potent inhibitor of 5α-reductase.14
Moreover, a recent study also demonstrated that azelaic
acid could improve telogen to anagen transition and
promote hair growth by upregulating Gli1 and Gli2
expression and protecting hair bulge cells from ultraviolet
B damage.15 erefore, azelaic acid might be an eective
treatment for AGA. ere are many commercial topical
preparations containing various concentrations of minoxidil
in combination with 5% azelaic acid. A previous randomized
controlled study on the ecacy of 5% minoxidil topical
solution monotherapy and a combination of 12.5%
minoxidil, 5% azelaic acid, and 0.025% betamethasone-
17-valerate showed a similar outcome in increasing hair
growth between both treatments, but the combination
solution signicantly decreased hair shedding compared
to 5% minoxidil monotherapy.17 However, evidence of the
ecacy of azelaic acid topical solution as a monotherapy
for AGA is lacking. Our study was the rst randomized
clinical study of the ecacy and safety of 5% azelaic
acid topical solution in comparison with 2% minoxidil
solution in the treatment of FPHL.
Both 5% azelaic acid and 2% minoxidil topical
solution signicantly increased both hair density and
hair diameter at 2, 4, and 6 months of treatment. ere
were no statistically signicant dierences between both
solutions in every follow-up visit (Table 2). Nonetheless,
the increases in hair density and the hair diameter of FPHL
patients treated with 5% azelaic acid solution were slightly
lower than those with 2% minoxidil solution, which is one
of the standard treatments for FPHL. e investigators
and patient’s own assessments also correlated with both
clinical parameters. Regarding GPR, slightly more FPHL
patients treated with 5% azelaic acid solution than 2%
minoxidil solution were considered to demonstrate mild
to moderate improvement at the end of the study. More
than half of the patients in both groups rated themselves
at least showing a moderate improvement from the
baseline condition.
e azelaic acid concentration in commercially
available hair formulations, combined with minoxidil
solution, varies between 1.5% to 5%. However, the 5%
azelaic acid used in our study was lower than typical
concentrations used for other dermatologic conditions,
such as rosacea, acne, and melasma, which range from
10% to 20%.13 A higher concentration of azelaic acid
might be more eective in improving hair thinning
but may also incur an increased risk of adverse events,
like pruritus, dryness, stinging, and burning sensation.
Further investigations are needed to establish the optimal
concentration of azelaic acid for the treatment of FPHL.
As mentioned above, the possible mechanisms of azelaic
acid in the improvement of FPHL could be that azelaic
acid may inhibit 5α-reductase14 and promote telogen
to anagen transition.15 Its anti-inammatory property
might also be another explanation. In a recent study,
it was reported that the pathophysiology of both male
pattern hair loss (MPHL) and FPHL may be inuenced
by the presence of perifollicular inammation.18 Azelaic
acid could reduce the synthesis of pro-inammatory
cytokines and reactive oxygen species, thus it might be
capable of improving PHL.13
e US Food and Drug Administration (FDA) has
classied azelaic acid as pregnancy category B and can
be used in pregnant and breastfeeding women, whereas
minoxidil is not recommended due to several reports
of fetal abnormalities.16 According to our study, azelaic
acid could be a treatment option for pregnant women
with pre-existing FPHL, particularly in patients who
have previously received anti-hair loss treatments, in
particular, because discontinuation of those treatments in
patients who were trying to conceive could further result
in a deterioration of hair thinning and nally lead to a
negative impact on their quality of life and self-esteem.
us, 5% azelaic acid topical solution might be a valuable
alternative to 2% minoxidil solution for the treatment
of FPHL in pregnancy, as not only would it improve
FPHL, but it would also relieve stress and be benecial
to the quality of life of patients during pregnancy, as
minoxidil is restricted in these patients.
Topical minoxidil could cause transient telogen
hair shedding in some patients in the rst 8 weeks of
treatment.2 In this study, we expected to nd no change
or perhaps a slightly worsening in hair density in patients
treated with 2% minoxidil at 2 months aer treatment.
However, our study showed that the hair density in
patients treated with 2% minoxidil increased at 2 months
and continued increasing throughout the study, similar
to a previous study.19 is suggested that hair shedding
following minoxidil therapy might actually resolve before
8 weeks, or the quantity of hair growth might outnumber
hair shedding.
In our study, the most common adverse eect was
pruritus in both groups of patients. e explanation for
this might be due to the inclusion of propylene glycol in
both solutions or the active ingredient itself. Propylene
glycol is a well-known allergen and irritant that can cause
contact dermatitis.20 Other vehicles or solvents may be
used instead of propylene glycol to avoid skin irritation.
A previous study showed that the rates of pruritus and
dandru were signicantly lower in patients treated
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with 5% minoxidil topical foam (propylene glycol-free
preparation) than in those treated with 2% minoxidil
topical solution.21 Further investigations are needed to
assess the ecacy and safety of dierent vehicles used
in azelaic acid topical preparations in the treatment
of FPHL. In our study, pruritus was more commonly
observed in patients treated with 5% azelaic acid solution
than in those treated with 2% minoxidil solution. is
might be because azelaic acid is also a skin irritant and
probably causes additional pruritus.
Even though this study was a randomized, double-
blind, comparative study, our sample size of 26 patients
can be regarded as being relatively small. To accurately
determine the eectiveness and long-term safety of
topical azelaic acid for the treatment of both MPHL and
FPHL patients, a larger sample size with longer research
periods is needed in the future.
In conclusion, 5% azelaic acid topical solution
might be an eective treatment for FPHL, comparable
to 2% minoxidil solution. Furthermore, it could be
an alternative treatment for FPHL in pregnant and
breastfeeding women. More research on azelaic acid
solution is needed to determine the optimal concentration
of azelaic acid and the proper vehicles to use in FPHL
preparations.
ACKNOWLEDGEMENTS
is research project was supported by the Siriraj
Research Fund, Faculty of Medicine Siriraj Hospital,
Mahidol University, Grant number (IO) R016132032.
All authors received no personal nancial interest from
the research fund. e authors also gratefully thank
Mr. Suthipol Udompunthurak of the Research Group
and Research Network Division, Research Department,
Faculty of Medicine Siriraj Hospital, Mahidol University
for assistance with the statistical analysis.
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