Therapy
Anne ISVY-JOUBERT1 Adult female acne treated with spironolactone:
Jean-Michel NGUYEN2,3
Aurélie GAULTIER2,3
Mélanie SAINT-JEAN1,3
Marie LE MOIGNE1,3
Elodie BOISROBERT1,3
Amir KHAMMARI1,3
Brigitte DRENO1,3
1 Department of Dermatology, Nantes
University Hospital, Nantes, France
2 Clinical Research Department,
Methodological Unit, Nantes, France
3 INSERM U892, 9 quai Montcousu 44093,
Nantes, France
Reprints: B. Dreno
<brigitte.dreno@wanadoo.fr>
Article accepted on 3/2/2017
T he prevalence of acne in the adult population is
increasing, particularly in women in whom 14%
to 54% of individuals are afflicted according to
different studies [1, 2, 3, 4, 5].
Two subtypes of acne in adult females are defined according
to the time at onset of the disease: (1) prolonged adolescent
acne, associated or not with periods of remission of varying
duration; and (2) late-onset acne, starting at the age of 25
years or later [1, 6, 7, 8].
An epidemiological study demonstrated that prolonged
adolescent acne is the most frequent (80%) compared to
late-onset acne [9]. The aetiology of both acne types is
similar and involves the colonization of the pilosebaceous
duct by Propionibacterium acnes and alterations in follic-
ular keratinization and differentiation with excess sebum
production. However, adult acne differs from adolescent
doi:10.1684/ejd.2017.3062
acne based on the hormonal factor which appears to be
particularly important as demonstrated by the flare-up of
acne lesions before menstruation, as well as the efficacy
of anti-androgens and oral fourth-generation contraceptives
for the treatment of acne. The reason for this may reside in
a hypersensitivity of androgen receptors identified in both
EJD, vol. 27, n◦ 4, July-August 2017
To cite this article: Isvy-Joubert A, Nguyen JM, Gaultier A, Saint-Jean M, Le Moigne M, Boisrobert E, Khammari A, Dreno B. Adult female acne treated with spironolactone:
a retrospective data review of 70 cases. Eur J Dermatol 2017; 27(4): 393-8 doi:10.1684/ejd.2017.3062
Eur J Dermatol 2017; 27(4): 393-8
a retrospective data review of 70 cases
Background: The prevalence of acne in the adult population is increas-
ing, particularly in women. Spironolactone regulates sebaceous gland
activity by blocking androgen receptor. Objectives: To evaluate retro-
spectively the efficacy of spironolactone in women with acne. Materials
& methods: Data from 70 women of at least 20 years, treated for
their acne between 2010 and 2015 with low-dose spironolactone
(≤150 mg/day), were analysed. Remission was defined by the number
of retentional lesions inferior or equal to five and inflammatory lesions
inferior or equal to two on the face. Variables influencing the response
were studied using the Cox model. Results: The mean age was 31.3
years; 39 (56%) women had prior courses of isotretinoin and 53 (76%)
had an oral contraception prior to treatment. Remission data from a
median treatment period of six months (95% CI: 4-9) were obtained
from 47 (71%) women. Markers for a positive response to spironolac-
tone were a high number of inflammatory lesions at inclusion (OR: 1.08;
95% CI: 1.03-1.13; p = 0.001) and relapse with previous isotretinoin
(OR: 2.46; 95% CI: 1.09-5.54; p = 0.03). The marker for a negative
response was an association with oral contraceptives containing first or
second-generation progestin (OR: 2.77; 95% CI: 1.35-5.71; p = 0.005).
Conclusion: This retrospective data analysis confirms that the use of
low doses of spironolactone is a valuable alternative in women with
acne in whom oral isotretinoin has failed. Moreover, the analysis shows
that first and second-generation oral contraceptives decrease the effi-
cacy of spironolactone, confirming the interest of using two third or
fourth-generation oral contraceptives.
Key words: adult, female, acne, spironolactone, contraception,
isotretinoin, progestin
sebocytes and keratinocytes and/or in an increased activ-
ity of enzymes involved in the metabolism of androgens in
sebocytes or keratinocytes [9, 10].
Clinical features of adolescent and adult female acne and
adolescent acne are similar: hyperseborrhoea, retentional
lesions (mainly closed comedones), and inflammatory
lesions are observed in both types. In addition, in adult
female acne, deep inflammatory lesions (cysts) located in
the mandibular region may be observed [6].
Spironolactone blocks androgen receptor, and its anti-
androgenic action is achieved by competitive inhibition
with dihydrotestosterone, as demonstrated by Rifka et al. on
human prepuce and prostate [11]. This competition occurs
on a specific cytosolic receptor and is not accompanied
by a decrease in 5-alpha-reductase activity [12]. How-
ever, Serafini et al. showed a decrease in 5-alpha-reductase
activity due to spironolactone [13]. This action on acne
remains unclear because the use of a selective inhibitor of
type I 5-alpha- reductase did not appear to lead to clinical
improvement of acne [14]. The positive role of spironolac-
tone is therefore rather linked to its anti-androgenetic action
through other routes.
393
Studies have demonstrated the efficacy of low doses of Table 1. Demographics and data at initiation of spironolac-
spironolactone on acne [15, 16, 17, 18, 19, 20]. However, to tone treatment.
date, no study has assessed the profile of women with acne
responding to this treatment. In the US, spironolactone has Age, years
been used off-label for a long time to treat acne [21]. Its use Mean ± SD 31.3 ± 8.4
as an oral acne treatment has not been granted in Europe. Range 20-52
Here, we report the results of a retrospective data analysis Acne onset
from women with acne treated with low doses of spironolac- Adolescence 54 (76%)
tone (≤150 mg/day). In addition, we investigated whether Adulthood 13 (18%)
treatment with spironolactone improves late-onset acne or Family history 50 (70%)
acne in the mandibular area, and propose an alternative to Previous oral isotretinoin course 39 (56%)
oral isotretinoin.
Contraception 53 (76%)
2nd and 4th -generation 17 (32%)
3rd and 4th -generation 15 (28%)
Material and methods Hormonal intrauterine contraceptive device 4 (8%)
Non-hormonal intrauterine contraceptive device 16 (30%)
Progestogen implant 0 (0%)
Study design Mechanical device 1 (2%)
Smoker 25 (36%)
This was a retrospective analysis of data from adult women
with acne treated with low doses (≤150 mg/day) of spirono- Breastfeeding 25 (36%)
lactone. The study complied with French legal requirements Sport ≥3 times/week 17 (24%)
for the conduct of retrospective studies. Beauty care 36 (51%)

Study population
Data from women with acne on the face or back and
with a minimum age of 20 years, who received spirono-
lactone between January 2010 and January 2015, were
analysed. Data from women with hydradenitis suppurativa
and rosacea and from women who concomitantly received
anti-androgens were not considered for the analysis.
Assessments
Efficacy and safety data from the first visit, when spirono-
lactone was prescribed, and from routine follow-up visits
at three to four months, six to eight months, and then every
six months, were analysed. Data collected at initiation of
spironolactone treatment included demographics and infor-
mation about onset, family history, and previous general
acne treatment with oral isotretinoin. Moreover, data on
breastfeeding, practicing sport at least three times per week,
external triggering factors such as sun exposure, stress,
smoking, contraception method, beauty care, seborrhoea
severity, and extra-facial acne were considered.
The main endpoint was the lesion count of superficial,
inflammatory total (papules and pustules) and retentional
lesions (open and closed comedones) on the face, back,
neck, and breast after six months of treatment. Good clinical
response (success) was defined as ≤2 superficial inflamma-
tory lesions (papules or pustules), ≤5 retentional lesions
(open or closed comedones), no nodules on the face, and
<5 superficial inflammatory lesions on the trunk including
the neck.
Data on acne severity was collected based on the number
of acne lesions using the ECLA scale (Evaluation Clinique
de Lésions d’Acné [Clinical Evaluation of Acne Lesions])
[22]. According to the ECLA, grading success was defined
as F1 R0 or R1, Is0 or 1 IP0, and F2 0 or 1 for the neck,
chest, and back, respectively.
Additionally, data concerning the severity level of sebor-
rhoea assessed at all visits using a semi-quantitative scale
(1 = mild, 2 = moderate, and 3 = severe) were collected.
Side effects were collected at each visit according to
the CTCAE (Common Terminology Criteria for Adverse
Events) classification [23].
Statistical analysis
Time to success was considered. During a first analysis,
all predicting factors were tested individually using a Cox
model. In a second step, a multivariate model was devel-
oped using a stepwise selection of predictors according to
the AIC (Akaike Information Criterion). The R3.2 software
was used for all analyses.
Results
Patient characteristics
Data from 70 women with a mean age of 31.3 years (20-34
years) were analysed; the majority of women had an acne
onset during adolescence. Detailed population characteris-
tics are summarized in table 1. A total of 53 women (76%)
had mild acne (<10 superficial inflammatory lesions), 12
women (17%) had moderate acne (10-20 superficial inflam-
matory lesions), and five women (7%) had severe acne (>20
superficial inflammatory lesions) (table 2).
Remission
A remission analysis was conducted on data from 52 women
with complete data profiles for all selected time points.
Of those patients, 71% (n = 47) were considered to have
been treated successfully. Among them, 28 (60%) were
reported to have a previous relapse under isotretinoin.
The observed median response occurred after six months
(CI 95%) [4, 5, 6, 7, 8, 9]. Figure 1 presents the response
of retentional, superficial inflammatory lesions on the neck,

394 EJD, vol. 27, n◦ 4, July-August 2017

Table 2. Clinical examination at initiation. ence was observed regarding family history or type of acne
(adult onset/pubertal onset), breastfeeding, a high level of
Seborrhoea carbohydrate consummation, beauty care, practicing sport,
0 or 1 or 2; n (%)* 54 (77%) the presence of lesions on the neck or trunk at inclusion, or
3 or 4; n (%)* 16 (23%) a predominance of retentional lesion.
Retentional lesions (median ± SD) 4.5 ± 10.4 Based on the AIC, three predicting factors were selected for
Superficial inflammatory lesions (mean ± SD) 6± the final Cox model: the use of first or second-generation
Mild <10; n (%) 53 (76%) oral contraception containing progestin, the number of
Moderate (10 to 20); n (%) 12 (17%) superficial inflammatory lesions, and previous use of oral
Severe >20; n (%) 5 (7%) isotretinoin. Results showed a significant decrease in suc-
Neck lesions cess (OR = 0.27; 95% CI: 0.10-0.77; p = 0.01) for women
0/1*; n (%) 62 (87%) with a first or second-generation oral contraception con-
2/3/4*; n (%) 8 (11%) taining progestin. In contrast, a high number of superficial
Back lesions inflammatory lesions at inclusion and previous treatment
0/1*; n (%) 60 (85)%
with oral isotretinoin significantly increased the probabil-
2/3*; n (%) 10 (15%) ity of success (OR = 1.08; 95% CI: 1.03-1.13; p = 0.001 and
Chest lesions
OR = 2.46; 95% CI: 1.09-5.54; p = 0.029, respectively).
Among the 18 women who stopped spironolactone due to
0/1* 68 (97%)
2/3* 2 (3%) a lack of efficacy, after a gradual decrease of 25 mg every
three months, four (22%) had relapsed after two and seven
*according ECLA graduation months, respectively, but had a positive response after the
reintroduction of spironolactone.

9
Seborrhoea
At inclusion, 72.9% of the patients had seborrhoea which
8 was graded superior or equal to Grade 2. After six months
of treatment with spironolactone, 14.3% of women were
7 still considered as Grade 2 and none were considered as
Grade 3.
6

5 Treatment-related side effects

For 17 patients (24%), treatment-related side effects were
4 reported; all were mild or moderate (Grade 1 or 2) according
the CTCAE classification. The most frequent side effects
3
were menstrual irregularities (8.6%), cramp/tetany (4.2%),
low blood pressure (2.9%), anorexia/loss of weight (2.9%),
2 and giddiness (2.9%). Maculo-papular rash, generalised
eczema, sadness, nausea, dysphagia, diarrhoea, pollakiuria,
1 hot flush, and breast tenderness were each reported in one
patient (1.4%). A clinical, but non-significant, increase in
0 serum potassium level was reported in one woman.
T0 6M 12M

Facial inflammatory superficial lesion

Facial retentionnal lesion
Back
Chest
Neck
Figure 1. Clinical response to spironolactone after 6 and 12
months of treatment.
chest, and back to spironolactone after six and 12 months of
treatment. Table 3A displays results obtained for each vari-
able assessed separately and table 3B summarises results
obtained using a multivariate model.
According to the univariate model, the predominance
of inflammatory superficial lesions was considered to
have significantly increased the response to spironolactone
(OR = 1.05; 95% CI: 1-1.1; p = 0.02). No significant differ-
Discussion
Results from our retrospective data analysis confirmed the
efficacy and safety of spironolactone in women with acne
on both the face and back. In total, 71% of the 70 women
corresponding to the selection criteria responded to spirono-
lactone within a median treatment duration of six months.
The severity of seborrhoea had decreased confirming its
anti-androgenic action.
The efficacy of spironolactone for the treatment of adult
female acne has been confirmed based on a certain num-
ber of studies varying in study design and sample size,
especially involving those patients in whom other systemic
acne treatments, such as cyclines, zinc and isotretinoin,
had failed. Improvement of acne observed in these studies
varied between 33% and 97% for a treatment duration rang-
ing from 2 to 49 months, with four of these studies using

EJD, vol. 27, n◦ 4, July-August 2017 395

Table 3A. Results from univariate Cox model.

OR 95% CI p value
Contraception
3rd /4th -generation contraception with low androgenic 0.47 [0.21–1.03] 0.059
activity of progestin1 0.83 [0.34–2.03] 0.685
1st /2nd -generation contraception with intrinsic
androgenic activity2
neutral3
Tobacco consumption 0.76 [0.41–1.48] 0.441
Previous treatment with isotretinoin 1.54 [0.83-4.85] 0.17
Acne onset 1.21 [0.3-4.93] 0.778
Adult
Family history 0.82 [0.45-1.49] 0.507
Breastfeeding 0.80 [0.47–1.61] 0.647
High level of carbohydrates 1.04 [0.57-1.9] 0.901
Sport >3 times/week 1.60 [0.82-3.10] 0.165
Beauty care 1.30 [0.71-3.37] 0.393
Neck lesions at initiation 0.72 [0.39-1.33] 0.29
Trunk lesions at initiation 0.79 [0.41-1.49] 0.459
Retentional lesions 0.98 [0.95-1.01] 0.194
Inflammatory superficial lesions 1.05 [1.01-1.10] 0.023*
OR 95% CI p value
Contraception
3rd /4th -generation contraception with low androgenic 0.47 [0.21–1.03] 0.059
activity of progestin 0.83 [0.34–2.03] 0.685
1st /2nd -generation contraception with intrinsic
androgenic activity2
neutral3
Tobacco consumption 0.76 [0.41–1.48] 0.441
Previous treatment with isotretinoin 1.54 [0.83–4.85] 0.17
Acne onset 1.21 [0.3–4.93] 0.778
Adult
Family history 0.82 [0.45–1.49] 0.507
Breastfeeding 0.80 [0.47–1.61] 0.647
High level of carbohydrates 1.04 [0.57–1.9] 0.901
Sport >3 times/week 1.60 [0.82–3.10] 0.165
Beauty care 1.30 [0.71–3.37] 0.393
Neck lesions at initiation 0.72 [0.39–1.33] 0.29
Trunk lesions at initiation 0.79 [0.41–1.49] 0.459
Retentional lesions 0.98 [0.95–1.01] 0.194
Inflammatory superficial lesions 1.05 [1.01–1.10] 0.023*
OR: odds ratio; CI: confidence interval; 1 lowest androgenic activity of third and fourth-generation oral contraception; 2 progestins with intrinsic
androgenic activity of first and second-generation oral contraception, hormonal intrauterine contraceptive device, implants containing progestogen;
3 neutral: mechanical and non-hormonal intrauterine contraceptive device;*p<0.05.

Table 3B. Results from the multivariate Cox model with selection.

Predictors OR [IC95%] p value

Contraception with intrinsic androgenic activity of progestins1 0.27 [0.10-0.77]2 0.01*
Inflammatory lesions at inclusion 1.08 [1.03–1.13] 0.001*
Previous treatment with isotretinoin 2.46 [1.09–5.54] 0.029*
1 lowest androgenic activity of third and fourth-generation oral contraception; 2 compared to third/fourth-generation contraception with low androgenic
activity of progestins (reference value = 0); *p<0.05.

396 EJD, vol. 27, n◦ 4, July-August 2017

lesion count to evaluate patient response [18, 19, 20, 24].
A prospective study conducted with 14 adult females with
acne reported, for the first time, a clinical response with
spironolactone after failure of systemic treatments (zinc,
isotretinoin and/or tetracyclines), in 37.5% of patients with
acne on the back [24]. The observed response rate was
similar to that of our study.
In contrast to these clinical studies, our data review defined
success based on a validated acne scale assessed by the
physician, combined with a scale for the back, and with
no patient self-assessment [22]. Moreover, in assessing
acne lesions on the back, we confirmed the efficacy of
spironolactone on extra-facial lesions which was already
reported by Saint-Jean et al. [25]. However, whereas mainly
patients with moderate acne (10-20 superficial inflamma-
tory lesions) were assessed, in our analysis, we reviewed
data on a majority of patients (76%) with mild acne (<10
superficial inflammatory lesions). In this population, we
observed that more than 50% of the patients received at least
one isotretinoin course prior to initiation of spironolactone,
which is superior to those reported previously [26] and that
in this type of patient, spironolactone provides a signifi-
cantly better treatment response. Our results confirm those
reported in a retrospective data review of 85 women with
acne treated with low-dose spironolactone (100 mg/day;
14% isotretinoin failure) in whom complete remission was
observed in 33% and a marked improvement in another
33%, with 21% of the cured patients having received only
spironolactone. Treatment response was based on exami-
nation by the physician and interim patient history without
any further details [17].
To our knowledge, we have defined, for the first time, fac-
tors that help predict the outcome of treatment response to
spironolactone, thus defining a patient responder profile.
Our data review supports the hypothesis that the clin-
ical response to spironolactone may be correlated with
the number of inflammatory superficial lesions and that
the clinical response to spironolactone decreases with
the concomitant use of oral first or second-generation
contraceptives containing progesterone, while it increases
with the concomitant use of third and fourth-generation
oral contraception. The latter observation was already
reported in a prospective study conducted with 27 women
receiving a combination of an oral contraceptive con-
taining drospirenone (fourth-generation contraceptive) and
spironolactone at 100 mg/day. After six months of treat-
ment, spironolactone was effective in 85% of patients while
menstrual bleeding had decreased [20].
The observed tolerance of spironolactone was similar to
that reported in the literature [17, 24, 27, 28]. The observed
increase in serum potassium level in one of our patients
was clinically not significant. This result was paralleled
by a study conducted with 967 women with acne treated
with spironolactone, at up to 200 mg/day. The authors con-
cluded that routine potassium monitoring is unnecessary
for healthy women taking spironolactone to treat their acne
[29].
In women with a desire for procreation, teratogenicity is
an important concern, while in women above the age of
35 years, an increased risk of skeletal side effects caused
by isotretinoin has been reported [30]. For these reasons,
alternative treatments to oral isotretinoin are important to
consider for women with acne. Current European guidelines
recommend hormonal therapies in combination with a top-
EJD, vol. 27, n◦ 4, July-August 2017
ical treatment or systemic antibiotics as an alternative to
first-line treatment with oral isotretinoin in female patients
with severe papulopustular/moderate nodular acne [31].
However, the increasing concern of resistance to antibiotics,
even though not yet demonstrated for systemic cyclines, and
the potential desire of women to avoid systemic contracep-
tives to treat their acne, make spironolactone a valuable
systemic acne treatment.
In conclusion, results from our data review and the success-
ful off-label treatment for more than 30 years confirm that
spironolactone may be a valuable alternative systemic ther-
apy for adult female acne. Unfortunately, to date, no country
has granted authorization for the marketing of spironolac-
tone for this indication. Prospective comparative studies
may provide new elements for reopening the debate on the
use of spironolactone for the treatment of acne in women
for whom oral isotretinoin is contraindicated or treatment
with systemic acne treatments has failed. 
Disclosure. Financial support: none. Conflict of interest:
none.
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