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Treatment of Acne Vulgaris During Pregnancy and Lactation

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Acne vulgaris is a common problem encountered by pregnant and lactating women. Unfortunately, in clinical practice, treatment is often not optimized as a result of the lack of safety data and unified recommendations on the use of the various anti-acne therapies. In this narrative review, current data on their safety is summarized. We recommend the use of topical medications as first-line treatment for acne vulgaris in pregnant and lactating women. These include antibiotics (erythromycin, clindamycin, metronidazole and dapsone), benzoyl peroxide, azelaic acid and salicylic acid. Oral agents and/or light-based therapy may be considered as second-line treatment. The former consists of oral macrolides (erythromycin and azithromycin), cephalexin or zinc compounds. Blue-violet or red light phototherapy may be used as monotherapy or in addition to topical and/or oral therapies. Hormonal therapy, antibiotics consisting of tetracyclines, co-trimoxazole and fluoroquinolones, and both oral and topical retinoids should be avoided.
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1 23
Drugs
ISSN 0012-6667
Volume 73
Number 8
Drugs (2013) 73:779-787
DOI 10.1007/s40265-013-0060-0
Treatment of Acne Vulgaris During
Pregnancy and Lactation
Y.L.Kong & H.L.Tey
1 23
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THERAPY IN PRACTICE
Treatment of Acne Vulgaris During Pregnancy and Lactation
Y. L. Kong H. L. Tey
Published online: 9 May 2013
ÓSpringer International Publishing Switzerland 2013
Abstract Acne vulgaris is a common problem encountered
by pregnant and lactating women. Unfortunately, in clinical
practice, treatment is often not optimized as a result of the
lack of safety data and unified recommendations on the use of
the various anti-acne therapies. In this narrative review,
current data on their safety is summarized. We recommend
the use of topical medications as first-line treatment for acne
vulgaris in pregnant and lactating women. These include
antibiotics (erythromycin, clindamycin, metronidazole and
dapsone), benzoyl peroxide, azelaic acid and salicylic acid.
Oral agents and/or light-based therapy may be considered as
second-line treatment. The former consists of oral macro-
lides (erythromycin and azithromycin), cephalexin or zinc
compounds. Blue–violet or red light phototherapy may be
used as monotherapy or in addition to topical and/or oral
therapies. Hormonal therapy, antibiotics consisting of tet-
racyclines, co-trimoxazole and fluoroquinolones, and both
oral and topical retinoids should be avoided.
1 Introduction
Acne vulgaris is a chronic dermatological disorder charac-
terized by the presence of comedones and inflammatory
papules, pustules and nodules mainly affecting sebaceous
gland-rich areas of the body. It is a disease of the piloseba-
ceous unit and results from four major pathophysiologic fac-
tors: seborrhea, hyperkeratinization, follicular colonization
with Propionibacterium acnes and, subsequently, the release
of immune mediators that result in inflammation [13].
Acne is a common condition, with a lifetime prevalence
of 85 % [1]. Although it is often perceived to be a disorder
afflicting only the youth, post-adolescent acne, which is
defined as acne affecting people more than 25 years of age,
has an incidence of up to 54 % in women and 40 % in men
and is increasingly being recognized [1]. Post-adolescent
acne has been consistently shown in studies to predominate
in females [1], and acne is a common problem faced by
pregnant women. During pregnancy, acne often worsens
because of a rise in serum androgen levels [4], which
results in an increase in sebum production and secretion.
Acne is well known to result in significant psychosocial
morbidity [5], and this is particularly significant during the
perinatal period, during which time post-natal blues and
depression may develop and have serious consequences.
The ubiquity and chronicity of acne vulgaris have led to a
growing number of acne medications being available on the
market. However, published information on the effects of
these medications on the developing fetus and infant is
limited. Pregnant or lactating women are often excluded
from clinical trials for ethical reasons. Available information
on the teratogenicity of these medications is often obtained
from cases of inadvertent exposure in which a woman has
used the products before she found out she was pregnant.
We reviewed the current literature to evaluate the safety
of the common and newer acne medications for use in
pregnancy and lactation. A PubMed search on the treatment
of acne vulgaris was performed over the last 35 years, from 1
January 1977 to 7 April 2013. The evidence for the safety of
these therapies in pregnancy and lactation was then evalu-
ated with reference to PubMed articles over the same 35-year
period, their manufacturers’ recommendations, medicine
package inserts and book chapters. As pregnant or lactating
women are almost always excluded from randomized control
trials, currently available evidence is limited to animal
Y. L. Kong H. L. Tey (&)
National Skin Centre, 1 Mandalay Road,
Singapore 308205, Singapore
e-mail: teyhongliang111@yahoo.com
Drugs (2013) 73:779–787
DOI 10.1007/s40265-013-0060-0
Author's personal copy
studies, retrospective studies, case reports, anecdotal evi-
dence and extrapolations from studies not designed to
directly examine the safety of these agents in pregnancy. The
results of our review are summarized and presented in a
narrative manner in this article.
2 Risk Classification Systems
One of the most widely used pregnancy classifications is
the US Food and Drug Administration (FDA) assessment
system, which stratifies drugs into five risk categories.
However, it has been heavily criticized for its focus on
animal data and its readiness to label new medications as
class B (safe in pregnancy). Other classification systems
available include the Australian, Swedish and German
systems, which rely more on human data, and recently, the
more comprehensive Evidence-based Medicine system,
which takes into consideration the timing of drug exposure
[6]. A comparison of the US FDA and Australian preg-
nancy classification systems is made in Table 1.
For drug risk in lactating mothers, the more established
rating systems include that from the American Academy of
Pediatrics (AAP) and the Lactation Risks Categories
described by Hale [7]. The former stratifies drugs into three
groups: those that should be ‘used with concern,’ those with
unknown effects but ‘may be of concern’ and those that are
generally ‘compatible with breast feeding’ [8]. A newer
resource is the Drug and Lactation Database (LactMed)
produced by the National Library of Medicine. This peer-
reviewed database provides consumers with comprehensive
information about drugs that may be used in breastfeeding
mothers, including serum drug levels, possible adverse
effects on infants and alternative drugs to consider [9].
3 Current Practice
The lack of unified drug classification systems in preg-
nancy and lactation as well as the grave consequences of
drug teratogenicity has led clinicians to adopt a very con-
servative approach when prescribing medications in these
groups of women. The common perception that acne is a
cosmetic problem further prompts clinicians to choose less
effective treatment or even to withhold treatment com-
pletely during pregnancy and lactation.
4 Topical Therapy
As a general rule, topical agents are safer than oral medi-
cations for use in pregnancy and lactation, as systemic
availability of the drug is lower.
4.1 Antibiotics
Older formulations include topical erythromycin (FDA cate-
gory B), clindamycin (B) and metronidazole (B), which are
generally thought to be safefor use in pregnancy and lactation
[10]. When applied topically, systemic absorption of eryth-
romycin and clindamycin has also been found to be negligible,
once again implying its safety [4].The manufacturer of topical
metronidazole, however, recommends caution in its use dur-
ing pregnancy as there have been reports of tumorigenicity in
animal studies [11]. Newer formulations that include topical
dapsone 5 % gel (C) and nadifloxacin (N) are less well stud-
ied. Embryotoxicity has been reported in animals exposed to
more than 500 times the levels of topical dapsone normally
prescribed in humans [12] but no adverse reproductive events
have been reported in humans so far. The probable safety of
topical dapsone is supported by the safe use of the oral for-
mulation in treating conditions like dermatitis herpetiformis in
pregnancy [13]. While oral dapsone has been reportedto cause
hemolytic anemia in breastfed infants [14], the topical for-
mulation is likely to be safe for use in lactation because of low
levels of systemic absorption, as suggested by tolerance of its
use in glucose-6-dehydrogenase (G6PD) deficiency and sul-
fonamide allergic patients [15]. Nadifloxacin is a topical
fluoroquinolone antibiotic that has been shown to be effective
in treating acne vulgaris [16].Therehavebeennoreportsof
reproductive adverse effects, but this is a relatively new drug
and data are therefore limited.
4.2 Retinoids
There are conflicting reports on the safety of topical reti-
noids such as tretinoin (C), adapalene (C) and tazarotene
(X) in pregnancy. Isolated cases of congenital malforma-
tions from use of these agents have been reported [17,18],
but these incidences may be coincidental. Larger scale
studies have shown no increased risk of retinoid embry-
opathy with use of topical retinoids [19,20]. In one of the
largest prospective studies to date, Panchaud et al. dem-
onstrated that there was no statistically significant differ-
ence in the rates of spontaneous abortions and major/minor
birth defects between women exposed to topical retinoids
and the control group [20].
Tretinoin and adapalene are probably compatible with
lactation because of the low levels of systemic absorption [4,
21,22]. The safety of tazarotene in breastfeeding is uncertain.
4.3 Comedolytics
These include benzoyl peroxide (C) and azelaic acid (B),
which also have antimicrobial properties. Although no
studies on the use of these agents in pregnant women have
been done, both have minimal systemic absorption, and
780 Y. L. Kong, H. L. Tey
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hence their use in pregnancy and lactation should not be a
cause for concern [4,10]. Salicylic acid (C) has been used
as an over-the-counter dermatological agent for many years
with no reports of teratogenicity. Its oral form, aspirin, is
being used in low dosages to prevent pre-eclampsia [23],
and this affirms its safety. There is a theoretical risk of
Reye’s syndrome with use of aspirin in breastfed infants
[24], but this is unlikely with topical salicylic acid because
of minimal skin absorption, especially if use is limited to
small areas of the skin [4].
4.4 Combination Therapy
Combination therapy targets different pathophysiologic
events simultaneously and has been shown to have
improved efficacy over monotherapy in the treatment of
acne vulgaris in general [3]. The more common combina-
tions include antibiotics with benzoyl peroxide or retinoids
and retinoids with benzoyl peroxide. Theoretically, there is
increased permeability of the skin with use of such
combinations and thereby a risk of increased systemic
exposure to the component drugs. However, studies have
failed to show an increase in transdermal intake [3], and the
use of combination therapy in pregnancy and lactation may
therefore be assumed to be safe.
5 Systemic Therapy
Systemic therapies for acne consist of oral medications,
which can broadly be divided into antibiotics, minerals,
hormonal therapy and retinoids.
5.1 Antibiotics
5.1.1 Macrolides
Erythromycin (B) has traditionally been the agent of choice
when a systemic antibiotic is needed during pregnancy
[10]. While largely reported to be safe for use, there have
Table 1 Comparison of the US and Australian drug safety in pregnancy classification systems
Category Definition
US Food and Drug Administration (FDA) system Australian system
A Controlled studies show no risk. Adequate, well-controlled
studies in pregnant women have failed to demonstrate a risk to
the fetus
Drugs taken by a large number of pregnant women and women of
childbearing age with no increase in the frequency of
malformations or other direct/ indirect harmful effects on the
fetus
B No evidence of risk. Animal reproduction studies have failed to
demonstrate a risk to the fetus and there are no adequate and
well-controlled studies in pregnant women
B1: limited experience in pregnant women and women of
childbearing age, with no increase in the frequency of
malformation or other direct/ indirect harmful effects on the
human fetus. Animal studies reassuring
B2: limited experience in pregnant women and women of
childbearing age, with no increase in the frequency of
malformation or other direct/ indirect harmful effects on the
human fetus. Animal studies are inadequate/ lacking, but
available data show no evidence of an increased occurrence of
fetal damage
B3: limited experience in pregnant women and women of
childbearing age, with no increase in the frequency of
malformation or other direct/ indirect harmful effects on the
human fetus. Animal studies have shown evidence of an
increased occurrence of fetal damage, the significance of which
is uncertain in humans
C Risk cannot be ruled out. Animal reproduction studies have
shown an adverse effect on the fetus, but use in pregnancy may
be justified if potential benefits outweigh risks
Pharmacological effects of drugs may cause harmful effects on
the human fetus or neonate without causing malformations.
These effects may be reversible
D Positive evidence of human fetal risk. Investigational or
marketing experience show risks to the fetus, but use in
pregnancy may be justified if potential benefits outweigh risks
Suspected or proven to cause malformations or other irreversible
damage on the fetus. These drugs may also have adverse
pharmacological effects
X Contraindicated in pregnancy. Studies in animals or humans and/
or investigational or marketing experience have shown positive
evidence for human fetal risk, which clearly outweighs
potential benefits in the patient
High risk of causing permanent damage to the fetus hence
contraindicated in pregnancy or when there is a possibility of
pregnancy
N No pregnancy category has been assigned NA
Treatment of Acne Vulgaris During Pregnancy and Lactation 781
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been reports of fetal cardiac malformations [25], and pro-
longed use of the estolate form has been associated with
fetal hepatotoxicity in 10–15 % of pregnant patients [10,
26]. If there is treatment failure or intolerable side effects
with erythromycin, newer macrolides such as azithromycin
(B) and roxithromycin (N) may be used. These drugs are
effective in the treatment of acne vulgaris, have a better
side effect profile and are less frequently associated with
bacterial resistance [2,27]. However, they are much more
expensive than erythromycin. Clinical experience with the
newer macrolides is lacking, but they are expected to have
a similar safety profile to erythromycin and have been
reported to be safe for use in pregnancy [2,28]. While
macrolides as a class have been classified by AAP as safe
during lactation, use of erythromycin during the 1st
2 weeks of life has been associated with subsequent
development of pyloric stenosis [29].
5.1.2 Cephalosporins
Use of cephalexin (B) in lactation has been associated with
infantile diarrhoea [30], but it is otherwise well established
as a safe drug to use in pregnancy and lactation [10].
However, it is rarely used in the treatment acne vulgaris.
While cephalosporins have been shown to have in vitro
activity against P. acne, it is hydrophilic and therefore
thought to penetrate microcomedones poorly in vivo [2].
Information regarding its efficacy in acne vulgaris is
sparse, but a retrospective study of 93 patients showed that
cephalexin is an effective anti-acne agent, with 78 % of
patients experiencing clinical improvement after a dosing
regimen of 500 mg twice daily over an average period of
8.8 months [31].
5.1.3 Tetracyclines
Tetracycline (D), while largely reported to be safe in the
1st trimester, affects calcification of the teeth if taken after
the 4th month of pregnancy and causes permanent teeth
discoloration. Cases of maternal liver toxicity associated
with the use of tetracycline in the 3rd trimester have also
been described [32,33]. While there is a theoretical risk of
bone and teeth malformation if tetracycline is used during
lactation, low concentrations of fetal absorption are
expected because of its strong binding with calcium ions in
breast milk, and it is generally considered safe for use in
breastfeeding [34]. Other anti-acne drugs from the same
class include doxycycline (D), minocycline (D), lymecy-
cline (N) and oxytetracycline (D). These drugs, while not
as extensively studied, are structurally related to tetracy-
cline and are expected to affect the fetal calcification
process similarly.
5.1.4 Co-Trimoxazole
Co-trimoxazole (C) is sometimes used in the treatment of
acne vulgaris recalcitrant to the macrolides and tetracyclines.
Use of this drug in the 1st trimester can lead to folic acid
deficiency, which may in turn result in neural tube defects,
structural malformations of the cardiovascular and urinary
system, and cleft lip or palate. Exposure in the 3rd trimester
has been linked to small for gestational age infants, as well as
hyperbilirubinemia [35]. It is considered safe for use in
lactation by the AAP and LactMed except when the baby is
premature, has severe jaundice or G6PD deficiency, during
which there is a higher risk of kernicterus.
5.1.5 Fluoroquinolones
Levofloxacin (C), a 3rd generation fluoroquinolone, has been
used successfully to treat acne vulgaris, especially in patients
who have failed treatment with other agents [36]. In preg-
nancy, fluoroquinolones should be avoided as they may have
deleterious effects on growing cartilage [37]. No adverse
effects have been reported from the use of levofloxacin in
nursing mothers, but pseudomembranous colitis in an infant
has been reported from maternal use of ciprofloxacin [38].
5.2 Minerals
5.2.1 Zinc
Zinc sulfate (N) and zinc gluconate (N) have been shown to
be effective in the treatment of acne vulgaris at elemental
doses of 30–150 mg daily [36]. Zinc is an essential trace
Table 2 Teratogenicity of isotretinoin
a
Features
External abnormalities
Ears—anotia, micropinna, small/absent external auditory canal
Eyes—microphthalmia
Facial dysmorphism
Cleft palate
Internal abnormalities
Central nervous system—cerebral abnormalities, cerebellar
malformation, hydrocephalus, microcephaly, cranial nerve
deficit
Cardiovascular system
Thymus gland abnormality
Parathyroid hormone deficiency
Suboptimal IQ
Spontaneous abortion
Premature births
a
Accutane [Package Insert], Welwyn Garden City, UK; Roche Lab.
Inc; 2012
782 Y. L. Kong, H. L. Tey
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Table 3 Summary of the use of acne drugs in pregnancy and lactation
Medication Pregnancy
rating
Lactation rating Recommendations
FDA
a
Aus
b
AAP
c
LactMed Pregnancy Lactation
Topical
Erythromycin B A Compatible Acceptable Safe for use Safe for use
Clindamycin B A Compatible Acceptable Safe for use Safe for use
Metronidazole B B2 Of concern Unlikely to be of
concern with topical
application
Likely safe for use Likely safe for use
Reports of tumorigenicity in animal studies [10]
No adverse reproductive events in humans
Dapsone C B2 Compatible Avoid in G6PD
deficiency, newborn/
premature infants
Likely safe, but studies lacking
Embryocidal effects in animal studies when administered
[5009the levels in humans [11]
Oral dapsone used to treat dermatitis herpetiformis in
pregnancy [12]
Likely safe, but studies lacking
Oral dapsone may cause hemolytic anemia in
breastfed infants [13], but unlikely with
topical dapsone due to low systemic
absorption
Nadifloxacin N Not
rated
Not rated Not rated Likely safe, but studies lacking Likely safe, but studies lacking
Tretinoin C D Not rated Low risk Avoid if possible
Reported case of otocerebral abnormalities [17]
Likely safe, due to low systemic absorption
[19]
Adapalene C D Not rated Low risk Avoid if possible
Reported case of oculocerebral malformations [18]
Likely safe, due to low systemic absorption
[20]
Tarazotene X Not
rated
Not rated Low risk Contraindicated in pregnancy Avoid in lactation. Safety in breastfeeding
poorly defined, excretion levels into breast
milk not determined
Benzoyl peroxide C Not
rated
Not rated Low risk Safe for use Safe for use, systemic absorption minimal
Azelaic acid B B1 Not rated Low risk Safe for use Safe for use, systemic absorption minimal
Salicylic acid C Not
rated
Not rated Not rated Likely safe
Low dose aspirin used for treatment of pre-eclampsia [21]
Likely safe, systemic absorption minimal if
used on small areas of skin
Possible risk of Reye’s syndrome with use of
aspirin [22]
Systemic
Erythromycin B A Compatible Acceptable Likely safe for use in pregnancy
Reported cases of cardiovascular anomalies [23] and
hepatotoxicity [24] in humans
Safe for use after first few weeks of birth
Reported case of pyloric stenosis when
exposed during early neonatal days [27]
Azithromycin B B1 Not rated Acceptable Likely safe for use, but studies lacking Likely safe, but studies lacking.
Roxithromycin N B1 Not rated Not rated Likely safe for use, but studies lacking Likely safe, but studies lacking.
Cephalexin B A Not rated Acceptable Safe for use Likely safe, but reported cases of diarrhea in
the breast-fed infant [28]
Treatment of Acne Vulgaris During Pregnancy and Lactation 783
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Table 3 continued
Medication Pregnancy
rating
Lactation rating Recommendations
FDA
a
Aus
b
AAP
c
LactMed Pregnancy Lactation
Tetracyclines
(and its
derivatives)
D D Compatible Short-term use
acceptable
Avoid in pregnancy
Fetal teeth discoloration reported [30] and maternal
hepatotoxicity [31] reported
Likely safe
Theoretical risk of affecting bone growth, but
low levels of fetal absorption as the drug
binds to calcium in the maternal milk
Co-trimoxazole C C Compatible Avoid in jaundiced, ill,
premature infants; or
in G6PD deficiency
Avoid in pregnancy
Reports of neural tube defects, structural malformations of the
cardiovascular and urinary system, cleft lip or palate with use
in 1st trimester. Small for gestational age infants and
hyperbilirubinemia reported with 3rd trimester use [33]
Avoid in neonates that are premature, has
severe jaundice or has G6PD deficiency, due
to a higher risk of kernicterus [5].
Levofloxacin C Not
rated
Not rated Short term use
acceptable
Avoid in pregnancy
Possible deleterious effects on growing cartilage [35]
Avoid in lactation
Perforated pseudomembranous colitis reported
in a breast fed infant whose mother
consumed ciprofloxacin [36]
Zinc salts N Not
rated
Not rated Not rated Likely safe, but studies lacking. Likely safe, but studies lacking.
Oral
contraceptive
pills
X B3 Compatible Avoid \4 weeks
postpartum
Avoid in pregnancy
Higher incidence of Down’s syndrome reported [38]
Risk of feminization of the male fetus, hypospadias [1]
Avoid in lactation
Reported to decrease milk production [39]
Risk of feminization of the male fetus [1]
Cyproterone
acetate
X B3/D
d
Not rated Not rated Avoid in pregnancy
Risk of feminization of the male fetus, hypospadias [1]
Avoid in lactation
Risk of feminization of the male fetus [1]
Spironolactone C B3 Compatible Appears acceptable
Isotretinoin X X Not rated No recommendation
made
Contraindicated in pregnancy
Teratogenic agent (see Table 2)
Avoid in lactation. Safety in breastfeeding
poorly defined, excretion levels into breast
milk not determined
Light-based treatment
Blue/red light
phototherapy
NA NA NA NA Safe for use Safe for use
Blue light used to treat neonatal
hyperbilirubinemia [42]
ALA-PDT C
e
Not
rated
e
Not rated
e
Not rated
e
Likely safe
Used in treatment of condyloma acuminata with no reports of
adverse pregnancy events [43]
Likely safe, but studies lacking
G6PD glucose-6-phosphate dehydrogenase
a
US Food and Drug Administration Classification System
b
Australian Classification System
c
American Academy of Pediatrics (AAP) Classification System
d
Dose dependent
e
Ratings for aminolevulinic acid
784 Y. L. Kong, H. L. Tey
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element that is needed for proper functioning of several
enzymes in our body. Studies have consistently proven that
at doses below 75 mg/day of elemental zinc, no harm is
posed to the growing fetus [39]. Literature on the use of
zinc salts in lactation is sparse, but no adverse effects have
been reported thus far.
5.3 Hormonal Therapy
Hormonal therapy includes oral contraceptive pills (OCP)
(X) and androgen receptor blockers such as cyproterone
acetate (X) and spironolactone (C), which are especially
useful in controlling acne vulgaris linked to hyperandrog-
enism. These anti-androgenic agents should be avoided
during pregnancy and lactation, as they have been associ-
ated with hypospadias and feminization of the male fetus
[1]. A higher incidence of Down syndrome has also been
noted with use of OCPs in early pregnancy [40]. Hormonal
therapy should be avoided in lactation for two reasons: the
estrogen content in OCPs has been reported to decrease
milk production [41], and there is a theoretical risk of fetal
feminization, especially in neonates who might be less
capable of metabolizing the additional hormones.
5.4 Retinoids
5.4.1 Isotretinoin
The teratogenic effects of isotretinoin (X) are well estab-
lished (Table 2). It should be avoided throughout preg-
nancy. The gravity of isotretinoin use in pregnancy is
highlighted by the establishment of iPLEDGE by the US
FDA in 2006, a risk management program aimed at elim-
inating fetal exposure to isotretinoin [42]. The manufac-
turer of isotretinoin has advised against its used in
lactation, though no adverse effect on the nursing baby has
been described. Acitretin, a similar drug from the same
class, has been studied extensively and is rated by the AAP
as being usually compatible with feeding.
6 Light-Based Therapy
6.1 Blue–Violet and Red Light Phototherapy
This is thought to work via the absorption of light by
endogenous porphyrins produced by P. acnes, which leads
Fig. 1 Suggested treatment algorithm for acne vulgaris in pregnant and lactating women
Table 4 Combined acne severity classification
Severity Definition
Comedones Inflammatory lesions Total lesion
count
Mild Fewer than
20
Fewer than 15 Fewer than
30
Moderate 20–100 15–50 30–125
Severe More than
100
More than 50 or more than
5 cysts
More than
125
Treatment of Acne Vulgaris During Pregnancy and Lactation 785
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to porphyrin activation, singlet oxygen production and
subsequently bacterial death. Red light activates porphyrins
to a lesser extent than blue light, but penetrates deeper into
the skin [43]. Because it uses a specific, safe wavelength of
light, blue light and red light are generally considered safe
for use in pregnant and lactating women. Its safety is fur-
ther affirmed by the use of blue light phototherapy to treat
neonatal hyperbilirubinemia [44].
6.2 Photodynamic Therapy (PDT)
This is a two-step process that involves the application of a
photosensitizing agent such as aminolevulinic acid (ALA)
(C) prior to exposure to visible light. The preferential
accumulation of photosensitizers in sebaceous glands helps
augment the response to light therapy [43]. The safety of
photosensitizers such as ALA in pregnancy and lactation is
not well established, with both animal and human studies
lacking. However, ALA-PDT has been used successfully to
treat condyloma acuminata in pregnant women with no
report of adverse pregnancy events [45]. Also, systemic
absorption of the topically applied photosensitizer is
expected to be insignificant, assuming the area of appli-
cation is small.
7 Recommendations
In deciding whether to treat acne in pregnancy and lacta-
tion, as well as in choosing a specific therapy, the physician
should consider the severity of acne, the potential risk of
the drug in question and the patient’s tolerance for risk
taking. A summary of the risk categories of the drugs used
for acne is presented in Table 3and a suggested treatment
algorithm is shown in Fig. 1. The clinical classification of
the severity of acne in the algorithm is in accordance with
the Combined Acne Classification System [46], and this is
detailed in Table 4.
As with established guidelines [47,48], we recommend
the use of topical anti-acne medications as first-line treat-
ment because of their low systemic exposure compared to
drugs taken orally. However, women should be advised
against applying copious amounts of topical drugs on
inflamed skin over prolonged periods of time and over a
large body surface area, as this may increase systemic
absorption. Topical antibiotics are all likely to be safe,
although information on newer agents such as nadifloxacin
and dapsone is lacking. Comedolytics, consisting of topical
benzoyl peroxide, salicylic acid and azelaic acid, are also
safe in pregnancy and lactation. Benzoyl peroxide and
azelaic acid have comparable efficacy [49] and contain
antibacterial properties in addition to being a comedolytic
[47]. Hence, their use is recommended over salicylic acid,
which has only moderate comedolytic effects [48]. There
are conflicting reports on the safety of topical retinoids in
pregnancy; hence we advise against their use, especially
since there are alternative comedolytic agents available.
If treatments with topical agents fail, systemic agents or
phototherapy may be considered. Macrolides and cepha-
losporins are generally safe for use in pregnancy and lac-
tation. We recommend erythromycin and azithromycin in
view of their established effectiveness and their safety
profile. Cephalexin has a good safety profile in pregnancy
and lactation, but its efficacy is less well established
compared to the macrolides. We do not recommend the use
of co-trimoxazole and fluoroquinolones because of their
associated risks. Zinc salts are an alternative for those who
prefer not to consume antibiotics, but patients should be
aware that results may be poorer than with the use of oral
antimicrobial agents [50]. Light-based treatment consisting
of blue–violet and red light phototherapy can be used
safely, and they can be used as either as monotherapy or in
addition to topical and oral therapies.
8 Conclusion
The level of evidence on the safety of acne therapies in
pregnancy and lactation is low. Based on available data, we
recommend the use of the following topical medications as
first-line treatment: antibiotics (erythromycin, clindamycin,
metronidazole and dapsone), benzoyl peroxide, azelaic
acid and salicylic acid. Oral agents and/or light-based
therapy may be considered as second-line treatment. The
former consists of oral macrolides (erythromycin and
azithromycin), cephalexin or zinc compounds. Blue–violet
or red light phototherapy may be used as monotherapy or in
addition to topical and/or oral therapies.
Conflict of interest The authors declare that they have no conflicts
of interest.
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Treatment of Acne Vulgaris During Pregnancy and Lactation 787
Author's personal copy
... e central tenets of acne treatment include benzoyl peroxide, topical or oral retinoids such as isotretinoin, antibiotics, and oral spironolactone [24]. A majority of these are associated with adverse effects and are especially dangerous during pregnancy and lactation [25]. Furthermore, they do not address the emotional aspects of psychodermatological conditions. ...
... ere were no severe adverse events reported in the Lactium group. e 12 reported adverse events were mild and manageable, demonstrating Lactium's strong safety profile compared to pharmacological agents used in stress relief and acne treatment [24][25][26]. Lactium may be useful in the management of psychodermatological diseases. Stress reduction may positively impact the severity, duration, and clinical course of these conditions, which are otherwise difficult to manage due to recurrent episodes of flare and remission. ...
Article
Full-text available
Stress plays an important role in the causation and aggravation of psychodermatological conditions such as acne vulgaris. Alpha casein hydrolysate (αs1-casein hydrolysate; Lactium) has been shown to decrease serum cortisol levels, reduce stress-related symptoms, and promote relaxation. “This study aimed to compare the efficacy and safety of Lactium™ plus standard care to those of standard of care alone in reducing stress levels and acne severity in patients with acne vulgaris.” The C.E.R.T.A.I.N trial (Name registered with Clinical Trials Registry-India-No. CTRI/2019/01/017172) is a randomized, controlled, multicenter, open-label, two-arm, investigator-initiated clinical trial. A total of 100 patients with moderate-to-severe acne vulgaris were enrolled and randomly assigned to one of the two groups: Lactium™ plus standard care or standard care alone. Stress levels were assessed using serum cortisol levels, Investigator’s Global Assessment (IGA) acne severity scale scores, Perceived Stress Scale (PSS) scores, and the Hamilton Anxiety Rating Scale (HAM-A) scores. The Dermatology Life Quality Index (DLQI) was also used to assess the impact of the skin disease on patients’ quality of life. At 12 weeks, stress levels were significantly lower in group A (Nixiyax plus standard of care) than that in group B(only standard care), as measured by the change in serum cortisol levels (4.75 ± 4.46 vs. −0.24 ± 5.22). Furthermore, the mean change in PSS scores (3.09 ± 2.04 vs. 0.90 ± 2.76) and HAM-A scores (5.11 ± 1.94 vs. 1.25 ± 3.13) was significant. Patients in both arms had a significant decrease in total, inflammatory, and noninflammatory acne lesions, as well as a significant improvement in DLQI and IGA scores. In patients with moderate-to-severe acne vulgaris, Lactium™ was found to be both safe and well-tolerated. Lactium™ plus standard care is more effective than standard care alone in reducing acne severity through stress reduction.
... Although no reported teratogenic e ect in animal, it is recommended to use with caution due to the risk of hemolytic anemia in G6PD de ciency patient. [51][52][53] Other than hyperpigmentation, azelaic acid is safely used in the treatment of acne vulgaris among pregnant women due to its antimicrobioal, comedolytic, and mild anti-in ammatory e ects. 39,48 Keratolytics are widely used in acne vulgaris treatment. ...
... There was very minimal risk of maternal hemolytic anemia in patient with glucose-6phosphatase dehydrogenase (G6PD) de ciency. 52,53 C Use with caution, might be prescribed if there is more bene t than its risk. ...
Article
Objective: We sought to know the efficacy and safety profile of topical products for use during pregnancy. Methods: We used PubMed, Embase, and Cochrane Library to review literature on topical products and pregnancy. Results: A majority of pregnant women develop skin changes, including physiological or hormonal changes, worsening of preexisting skin conditions, or the appearance of new dermatoses during pregnancy. Most pregnant women are concerned about the availability of treatments options with good safety profiles, especially for skin and hair treatments, to maintain their appearance and health. Although most of the treatments are recommended to be used after delivery, there are some alternatives to prevent and treat skin lesions during pregnancy. Conclusion: The most current and comprehensive information about the efficacy and safety profile of topical products in pregnancy are necessary.
... It is better to begin with a low dose and concentration and gradually increase as the skin develops tolerance. FDA classifies benzoyl peroxide as pregnancy risk category C. It is considered safe for breastfeeding until and unless benzoyl peroxide comes directly in contact with the area with which the infant could have direct contact during breastfeeding [9]. ...
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Acne vulgaris is one of the most common skin diseases, affecting mainly teenagers. Its treatment procedure is complex, with a long duration of medication. Antibiotics are the most preferably prescribed drugs for the treatment of acne. The long-term use of antibiotics leads to various adverse effects such as the disruption of indigenous flora and resistance. Therefore, numerous therapeutic protocols such as antimicrobial stewardship have been proposed to limit the haphazard use of oral antibiotics. This review emphasizes different topical drugs, systemic alternative drugs, laser, and light therapy, as effective therapies for acne. This review also briefly reflects the efficacy of fire needle therapy—a traditional Chinese therapy—for acne.
... Short contact therapy utilizing a 2-minute skin contact time with BP 9.8% emollient foam used once daily over a 2-week duration was highly effective in reducing the quantity of P acnes organisms on the back and provided comparable colony count reduction to "leave on" therapy using BP 5.3% emollient foam [182]. The FDA classifies benzoyl peroxide as pregnancy risk category C [186], (Figure- ...
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Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) is an emerging technique for the treatment of genital human papillomavirus (HPV)-induced benign and premalignant lesions. We report here in a case series of condyloma acuminata (CA) in pregnancy successfully treated with ALA-PDT. Five pregnant patients with CA received three to four times treatment respectively. Patients were followed up for 6 - 23 months after treatment. The clearance rate of genital warts was 100%. No recurrence was found during the follow-up period. Major adverse events reported were mild erosion, pain, and local edema. All pregnancies resulted in healthy live births without delivery complications. PDT with topical ALA seems to be safe and effective in the treatment of CA in pregnancy. It demonstrated high clearance rate of warts, was well-tolerated by patients, and showed no adverse effects on mothers or fetuses. ALA-PDT may be an ideal strategy of treatment for pregnant women with CA.
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Acne and rosacea compromise a substantial portion of the dermatology clinical practice. Over the past century, many treatment modalities have been introduced with antibiotics playing a major role. Today, both oral and topical antibiotics are used in the management of acne and rosacea, with several novel formulations and/or combination regimens recently introduced. The latest studies suggest anti-inflammatory actions to be the most likely mechanism of antibiotics in acne and rosacea, shifting the focus to subantimicrobial-dose oral antibiotics and/or topical antibiotic regimens as the preferred first-line agents. Here we will discuss the most recent oral and topical antibiotic therapies available for treatment of acne and rosacea, with special focus on efficacy data, indication, dosing, and mechanism of action.