this month's acne supplement

19 Pages·2017·4.11 MB·English

BRIEF SUMMARY OF PRESCRIBING INFORMATION The significance of these spontaneous reports in terms of risk to the fetus is not known.
This Brief Summary does not include all the information needed to use RETIN-A MICRO safely For purposes of comparison of the animal exposure to systemic human exposure, the MRHD applied
and effectively. See full prescribing information for RETIN-A MICRO. topically is defined as 1 gram of Retin-A Micro (tretinoin) Gel microsphere, 0.1%, applied daily to a 60 kg
RETIN-A MICRO® (tretinoin) gel microsphere, 0.1%, 0.08%, 0.06% and 0.04%, for topical use person (0.017 mg tretinoin/kg body weight).
Initial U.S. Approval: 1971 Pregnant rats were treated with Retin-A Micro (tretinoin) Gel microsphere, 0.1%, at daily dermal doses
of 0.5 to 1.0 mg/kg/day tretinoin on gestation days 6-15. Alterations were seen in vertebrae and ribs of
INDICATIONS AND USAGE
offspring at 5 to 10 times the MRHD based on the body surface area (BSA) comparison.
Retin-A Micro® is a retinoid indicated for topical application in the treatment of acne vulgaris.
Pregnant New Zealand White rabbits were treated with Retin-A Micro (tretinoin) Gel microsphere, 0.1%,
CONTRAINDICATIONS at daily dermal doses of 0.2, 0.5, and 1.0 mg/kg/day tretinoin on gestation days 7-19. Doses were
None. administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the
drug. Increased incidences of certain alterations, including domed head and hydrocephaly, typical of
WARNINGS AND PRECAUTIONS retinoid-induced fetal malformations in this species, were observed at 0.5 and 1.0 mg/kg/day. Similar
Local Irritation malformations were not observed at 0.2 mg/kg/day, 4 times the MRHD based on BSA comparison.
The skin of certain individuals may become excessively dry, red, swollen, or blistered. Other pregnant rabbits exposed topically for six hours per day to 0.5 or 1.0 mg/kg/day tretinoin while
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with restrained in stocks to prevent ingestion, did not show any malformations at doses up to 19 times
utmost caution in patients with this condition. (1.0 mg/kg/day) the MRHD based on BSA comparison, but fetal resorptions were increased at 0.5 mg/kg
If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or (10 times the MRHD based on BSA comparison).
frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Oral tretinoin has been shown to cause malformations in rats, mice, rabbits, hamsters, and nonhuman
Efficacy at reduced frequencies of application has not been established. If a reaction suggesting primates.
sensitivity occurs, use of the medication should be discontinued. Tretinoin induced fetal malformations in Wistar rats when given orally at doses greater than 1 mg/kg/day
To help limit skin irritation, patients must (10 times the MRHD based on BSA comparison). In the cynomolgus monkey, fetal malformations were
• wash the treated skin gently, using a mild, non-medicated soap, and pat it dry, and reported for doses of 10 mg/kg/day but none were observed at 5 mg/kg/day (95 times the MRHD based
on BSA comparison), although increased skeletal variations were observed at all doses. Dose-related
• avoid washing the treated skin too often or scrubbing it hard when washing.
increases in embryolethality and abortion also were reported. Similar results have also been reported in
Patients should apply a topical moisturizer if dryness is bothersome. pigtail macaques.
Exposure to Ultraviolet Light or Weather Extremes In oral peri- and postnatal development studies in rats with tretinoin, decreased survival of neonates and
Unprotected exposure to sunlight, including sunlamps (UV light) should be avoided or minimized during growth retardation were observed at doses in excess of 2 mg/kg/day (19 times the MRHD based on BSA
the use of Retin-A Micro and patients with sunburn should be advised not to use the product until fully comparison).
recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients
who may be required to have extended periods of UV exposure (e.g., due to occupation or sports), or Nonteratogenic effects on fetus
those with inherent sensitivity to the sun, or those using medications that cause photosensitivity, should Oral tretinoin has been shown to be fetotoxic in rats when administered at doses 24 times the MRHD
exercise particular caution. Use of sunscreen products (SPF 15 or higher) and protective clothing over based on BSA comparison.
treated areas are recommended when exposure cannot be avoided [see Nonclinical Toxicology]. Topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 10 times the
Weather extremes, such as wind or cold, also may be irritating to tretinoin-treated skin. MRHD based on BSA comparison.
Nursing Mothers
ADVERSE REACTIONS It is not known whether tretinoin and/or its metabolites are excreted in human milk. Because many
Clinical Trials Experience drugs are excreted in human milk, caution should be exercised when Retin-A Micro is administered to a
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed nursing woman.
in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug
and may not reflect the rates observed in practice. Pediatric Use
Safety and effectiveness in children below the age of 12 have not been established.
Clinical Trials in Subjects with Acne
Geriatric Use
In separate clinical trials for each concentration, acne subjects treated with Retin-A Micro (tretinoin) Gel Safety and effectiveness in a geriatric population have not been established. Clinical trials of Retin-A
microsphere, 0.1% or 0.04%, over the twelve-week period showed that cutaneous irritation scores for Micro (tretinoin) Gel microsphere, 0.1% and 0.04%, did not include sufficient numbers of subjects aged
erythema, peeling, dryness, burning/stinging, or itching peaked during the initial two weeks of therapy,
65 and over to determine whether they responded differently from younger subjects.
decreasing thereafter.
Approximately half of the subjects treated with Retin-A Micro, 0.04%, had cutaneous irritation at OVERDOSAGE
Week 2. Of those subjects who did experience cutaneous side effects, most had signs or symptoms that Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with
were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, excessive oral intake of Vitamin A.
and 3=severe). Less than 10% of patients experienced moderate cutaneous irritation and there was no
severe irritation at Week 2. NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
In trials of Retin-A Micro (tretinoin) Gel microsphere, 0.04%, throughout the treatment period the majority
Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin) Gel microsphere,
of subjects experienced some degree of irritation (mild, moderate, or severe) with 1% (2/225) of subjects
0.1%, 0.08%, 0.06% or 0.04%.
having scores indicative of a severe irritation; 1.3% (3/225) of subjects treated with Retin-A Micro
(tretinoin) Gel microsphere, 0.04%, discontinued treatment due to irritation, which included dryness in In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations
one patient and peeling and urticaria in another. of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed
In trials of Retin-A Micro (tretinoin) Gel microsphere, 0.1%, no more than 3% of subjects had cutaneous in some female mice. These concentrations are near the tretinoin concentration of the 0.04% and 0.1%
irritation scores indicative of severe irritation; 6% (14/224) of subjects treated with Retin-A Micro clinical formulations. A dose-related incidence of liver tumors in male mice was observed at those
(tretinoin) Gel microsphere, 0.1%, discontinued treatment due to irritation. Of these 14 subjects, four had same doses. The maximum systemic doses associated with the administered 0.017% and 0.035%
severe irritation after 3 to 5 days of treatment, with blistering in one subject. formulations are 0.5 and 1.0 mg/kg/day tretinoin, respectively. These doses are two and four times the
MRHD based on BSA comparison.
In a double-blind trial with 156 acne subjects comparing 12 weeks of treatment with Retin-A Micro
(tretinoin) Gel, 0.04% or 0.1%, (78 subjects each group), the most frequently reported adverse events The biological significance of these findings is not clear because they occurred at doses that exceeded
affected the skin and subcutaneous tissue (15.4% in the 0.04% group, and 20.5% in the 0.1% group). the dermal maximally tolerated dose of tretinoin and because they were within the background natural
The most prevalent of the dermatologic adverse events in the 0.04% group was skin irritation (6.4%); occurrence rate for these tumors in this strain of mice.
and in the 0.1% group skin burning (7.7%), erythema (5.1%), skin irritation (3.8%), and dermatitis There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered
(3.8%). Most adverse events were of mild intensity (63.4%), and 34.4% were moderate. One subject in topically to mice (0.1 times the MRHD based on BSA comparison). Studies in hairless albino mice
each group had adverse events characterized as severe, neither were dermatologic findings and neither suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic
was characterized as related to drug by the investigator. doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in
Trials in Subjects without Acne pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis
by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should
In a half-face comparison trial conducted for up to 14 days in women with sensitive skin, but without minimize exposure to sunlight or artificial ultraviolet irradiation sources [see Warnings and Precautions].
acne, Retin-A Micro (tretinoin) Gel microsphere, 0.1%, was statistically less irritating than tretinoin
cream, 0.1%. In addition, a cumulative 21-day irritation evaluation in subjects with normal skin showed The genotoxic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse
that Retin-A Micro (tretinoin) Gel microsphere, 0.1%, had a lower irritation profile than tretinoin cream, 0.1%. micronucleus assay, both of which were negative.
The clinical significance of these irritation studies for patients with acne is not established. Comparable The components of the microspheres have shown potential for genetic toxicity and fetal malformation.
effectiveness of Retin-A Micro (tretinoin) Gel microsphere, 0.1%, and tretinoin cream, 0.1%, has not EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural
been established. The lower irritancy of Retin-A Micro (tretinoin) Gel microsphere, 0.1%, in subjects chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the
without acne may be attributable to the properties of its vehicle. The contribution of decreased irritancy absence of metabolic activation, and negative for genetic toxicity in the Ames assay, and the in vivo
by the MICROSPONGE System has not been established. No irritation trials have been performed to mouse micronucleus assay.
compare Retin-A Micro (tretinoin) Gel microsphere, 0.04%, with either Retin-A Micro (tretinoin) Gel In oral fertility studies in rats with tretinoin, the no-observable effect level was 2 mg/kg/day (19 times the
microsphere, 0.1%, or tretinoin cream, 0.1%. MRHD based on BSA comparison).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Retin-A Micro Gel. PATIENT COUNSELING INFORMATION
Because these reactions are reported voluntarily from a population of uncertain size, it is not always Advise the patient to read the FDA-approved patient labeling (Patient Information).
possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Manufactured for:
Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
USE IN SPECIFIC POPULATIONS By:
Pregnancy Valeant Pharmaceuticals International, Inc.
Pregnancy Category C Laval, Quebec H7L 4A8, Canada
There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used Retin-A Micro is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Microsponge is a registered trademark of AMCOL International Corporation. Any other product/brand
Thirty human cases of temporally associated congenital malformations have been reported during two names are trademarks of the respective owners.
decades of clinical use of tretinoin products. Although no definite pattern of teratogenicity and no causal
association has been established from these cases, five of the reports describe the rare birth defect ©Valeant Pharmaceuticals North America LLC
category holoprosencephaly (defects associated with incomplete midline development of the forebrain). Based on 9612500 October 2017 RAM.0025.USA.17
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DermatologyTimes
JUNE 2018 | Vol. 39, Supp. 2 A SUPPLEMENT T0
5
GENETICS
Twins study shows
acne genetic link
6
TREATMENT
COSTS
As costs rise, medication
compliance declines
9
TRANSGENDER
PATIENTS
Acne management raises
unique considerations
10
SUBCISION
TECHNIQUES
Blunt cannula or Nokor
needle?
12
ISOTRETINOIN
THERAPY
Review reaf rms its
value as acne Tx
14
LIGHT
THERAPIES
Where’s the evidence?
N
OTI J
CK/ K UN
UTTERSTO E 201
O: SH 8
HOT 4
P
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DermatologyTimes
WWW.D E R M ATO L O GY T I M E S .COM ¨
Twins study
conf rms genetic
link in acne
SOCIAL AND ENVIRONMENTAL FACTORS
INFLUENCE SYMPTOM SEVERITY
bAy Ilya Petrou, M.D. | Staff Correspondent

recent acne study1 in identical and fraternal twins indicates the condition may be
primarily caused by genetics, and that social and environmental factors influence
acne symptom severity. Raising awareness of the triggers that may exacerbate the
condition may help in the treatment and management of acne patients.
ÒAs already confirmed in other acne studies, we also social and environmental factors play a direct role in acne
found a definite genetic predisposition to acne. Upon this, severity. A twin-to-twin subset analysis of 56 identical twin
we believe it is very important to engage more awareness in pairs who had acne but differed in self-reported acne severity
terms of the exogenous factors or triggers that could aggra- revealed differences that could serve as triggers, such as a
vate acne. It is paramount that we address everything we can high sugar diet, a higher BMI, and lower frequency of exer-
proactively for the benefit of acne patients in the long-run,Ó cise compared to twins without acne.
said Elma D. Baron, M.D., professor of dermatology at Case Other studies have also shown the relationship of BMI
Western Reserve University, Cleveland, Ohio, and chief of with acne. According to Dr. Baron, it has become common
dermatology at Louis Stokes Cleveland VA Medical Center, knowledge that a higher BMI and a growing list of other
and co-author of the study. proinflammatory conditions can negatively impact the skin,
Dr. Baron and fellow colleagues conducted an acne survey such as in psoriasis and, possibly, also acne and rosacea.
study that included the data of 202 identical (101 pairs) and However, how to best implement or adjust practice with this
53 (26 sets) fraternal twins, as well as one set of fraternal accrued knowledge can be challenging.
triplets. All participants, on average, were young, predomi- ÒAlthough our study did not establish a correlation
nantly female, and the majority were Fitzpatrick Skin Types between sugar intake and acne, it did find a correlation
II-III. Study metrics included patient demographics, BMI between sugar intake and acne severity. It is important that
measurements, medical/family/social history, and physical we raise awareness of the impact of a high glycemic diet and
J
activity. Participants were surveyed for acne incidence, age the severity of acne among our acne patients so that such U
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of onset, severity, and triggers. triggers can be better avoided, as well as possibly improving E

Data showed that the proportion of pairs where twins general health,Ó Dr. Baron said. 2
0
1
have acne was significantly higher in identical (64%) In similar to previous studies, it was found that acne patients 8
compared to fraternal (49%) twins. It was also found that Twins CONTINUED ON PAGE 16
5
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ACNE MANAGEMENT CONSIDERATIONS
Cost a barrier
to medication
adherence
STUDY EXAMINES PATIENT MINDSET
Pby John Jesitus | Staff Correspondent
atient nonadherence to costly acne medications may be overcome
by physicians telling patients upfront that preferred medications
might be expensive.
This is important because a study in JAMA Dermatology of tions for medications or have high deductibles.”
structured interviews with 26 nonadherent patients from four Dr. Lipoff tells Dermatology Times that he finds out later
dermatology practices in the Philadelphia area found that cost from patients that they did not fill prescriptions, although he
was the major barrier to initiating t6herapy. 5 assumed that had.
%
“I suspected that cost “I also receive too many calls from patients that a medication,
was increasingly a barrier to even a generic topical medication that I expected to be inexpen-
patients receiving medica- sive, is $200 out of pocket,” he says.
tions, and acne was a prime Dr. Lipoff thought it was important to investigate, in depth,
example,” says co-author the barriers that patients experience and what goes through
Jules Lipoff, M.D., an a patient’s mind when they do not follow through in filling a
assistant professor of derma- prescription.
Patients who intended
tology at the University to fi ll prescriptions for The patient interviews revealed that 65% of patients had
of Pennsylvania. “More acne treatment, but did intended to fill prescriptions, but did not
and more, insurances are not because of cost or because of cost or coverage-related barriers.
requiring prior authoriza- coverage-related barriers. High out-of-pocket cost was cited by 42% of
patients and lack of insurance coverage by
PHYSICIAN-SUGGESTED APPROACHES 38%.
TO SECURE MEDICATIONS In addition, 54% of patients were
surprised by high medication cost when
} Ask patients to call back Dr. Lipoff visiting pharmacies.
8 } Suggest patients shop around Similarly, 19% of patients reported receiving confusing and
1 inconsistent instructions from different sources about prior
0
2 } Propose alternatives to non-covered, authorization; fragmented interaction between the physician,

E
N first-line medication pharmacy staff and physician’s office staff; and confusion over
U
J } Offer coupons to subsidize medication cost their own role in the prior authorization process.
6 Cost CONTINUED ON PAGE 16
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BRIEF SUMMARY OF PRESCRIBING INFORMATION Nursing Mothers
This Brief Summary does not include all the information needed to use It is not known whether clindamycin is excreted in human milk following use of
Clindagel® safely and effectively. See full prescribing information for Clindagel®. However, orally and parenterally administered clindamycin has been
Clindagel®. reported to appear in breast milk. Because of the potential for serious adverse reactions
in nursing infants, a decision should be made whether to discontinue nursing or to
Clindagel® (clindamycin phosphate gel) topical gel, 1% discontinue the drug, taking into account the importance of the drug to the mother.
For External Use Pediatric Use
Safety and effectiveness in children under the age of 12 have not been established.
INDICATIONS AND USAGE
Geriatric Use
Clindagel® is indicated for topical application in the treatment of acne vulgaris. In
The clinical study with Clindagel® did not include sufficient numbers of patients aged 65
view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis,
and over to determine if they respond differently than younger patients.
the physician should consider whether other agents are more appropriate. (See
CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS).
ADVERSE REACTIONS
CONTRAINDICATIONS In the one well-controlled clinical study comparing Clindagel® and its vehicle, the
incidence of skin and appendages adverse events occurring in ≥1% of the patients in
Clindagel® is contraindicated in individuals with a history of hypersensitivity to
either group is presented below:
preparations containing clindamycin or lincomycin, a history of regional enteritis or
ulcerative colitis, or a history of antibiotic-associated colitis.
Number (%) of Patients
WARNINGS Clindagel® Vehicle Gel
QD QD
Orally and parenterally administered clindamycin has been associated with
severe colitis, which may result in patient death. Use of the topical formulation Body System/Adverse Event N=168 N=184
of clindamycin results in absorption of the antibiotic from the skin surface. Skin and appendages disorders
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis)
Dermatitis 0 (0.0) 1 (1.2)
have been reported with the use of topical and systemic clindamycin.
Studies indicate a toxin(s) produced by Clostridia is one primary cause of Dermatitis contact 0 (0.0) 1 (1.2)
antibiotic-associated colitis. The colitis is usually characterized by severe Dermatitis fungal 0 (0.0) 1 (1.2)
persistent diarrhea and severe abdominal cramps and may be associated
with the passage of blood and mucus. Endoscopic examination may reveal Folliculitis 0 (0.0) 1 (1.2)
pseudomembranous colitis. Stool culture for Clostridium difficile and stool Photosensitivity reaction 0 (0.0) 1 (1.2)
assay for C. difficile toxin may be helpful diagnostically.
Pruritus 1 (0.6) 1 (1.2)
When significant diarrhea occurs, the drug should be discontinued. Large
bowel endoscopy should be considered to establish a definitive diagnosis Rash erythematous 0 (0.0) 0 (0.0)
in cases of severe diarrhea. Antiperistaltic agents, such as opiates and Skin dry 0 (0.0) 0 (0.0)
diphenoxylate with atropine, may prolong and/or worsen the condition.
Peeling 1 (0.6) 0 (0.0)
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin
up to several weeks following cessation of oral and parenteral therapy with
clindamycin. Orally and parenterally administered clindamycin has been associated with severe colitis,
which may end fatally.
PRECAUTIONS
Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have
General been reported as adverse reactions in patients treated with oral and parenteral formulations
Clindagel® should be prescribed with caution in atopic individuals. of clindamycin and rarely with topical clindamycin (see WARNINGS). Abdominal pain and
gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in
Drug Interactions
association with the use of topical formulations of clindamycin.
Clindamycin has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Therefore, it should be used
To report SUSPECTED ADVERSE REACTIONS, contact
with caution in patients receiving such agents.
Valeant Pharmaceuticals North America LLC at 1-800-321-4576 and/or FDA at
Carcinogenesis, Mutagenesis, Impairment of Fertility 1-800-FDA-1088 or www.fda.gov/medwatch
The carcinogenicity of a 1% clindamycin phosphate gel similar to Clindagel® was
evaluated by daily application to mice for two years. The daily doses used in this OVERDOSE
study were approximately 3 and 15 times higher than the human dose of clindamycin
Topically applied Clindagel® may be absorbed in sufficient amounts to produce systemic
phosphate from 5 milliliters of Clindagel®, assuming complete absorption and based
effects (see WARNINGS).
on a body surface area comparison. No significant increase in tumors was noted in the
treated animals.
US Patent No. 6,387,383
A 1% clindamycin phosphate gel similar to Clindagel® caused a statistically significant
shortening of the median time to tumor onset in a study in hairless mice in which tumors Manufactured for: Valeant Pharmaceuticals North America LLC
were induced by exposure to simulated sunlight. Bridgewater, NJ 08807 USA
Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella
reversion test. Both tests were negative. Reproduction studies in rats using oral doses by: DPT Laboratories, Ltd.
of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no San Antonio, Texas 78215 USA
evidence of impaired fertility.
Pregnancy: Teratogenic effects-Pregnancy Category B
Reproduction studies have been performed in rats and mice using subcutaneous and oral
doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate
hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used
in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate
dose of 432 mg/kg. For a rat, this dose is 84 fold higher and for a mouse 42 fold higher,
than the anticipated human dose of clindamycin phosphate from Clindagel® based Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
on a mg/m² comparison. There are, however, no adequate and well-controlled studies © Valeant Pharmaceuticals North America LLC.
in pregnant women. Because animal reproduction studies are not always predictive of Based on 9496600 Rev. 11/15
human response, this drug should be used during pregnancy only if clearly needed. CLG.0019.USA.18
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Female-to-male
transgender patient
considerations
ATTENTION TO UNIQUE FACTORS ADVISED
bIy Ingrid Torjesen | Staff Correspondent
n recent years the number of adolescents who feel that they do not identify with the gender
that was assigned to them at birth and who have sought gender reassignment treatment
— in the form of hormones or surgery — has increased.
Testosterone is frequently prescribed to female-to-male gender adolescents, aged 16-18, presented at the Hospital
transgender persons to aid masculinization by promoting voice Clínico San Carlos in Madrid with testosterone-associated
deepening and a masculine pattern of hair, fat, and muscle acne of differing intensity.3 Four had acne before beginning
distribution. However, testosterone is associated with a number testosterone treatment, and all of them experienced an
of dermatologic adverse effects, including increased presence increase in its intensity.
and severity of acne during the first year of treatment and long- Current guidelines are appropriate for treating acne in
term androgenetic alopecia.1 female-to-male transgender adolescents but with some notable
As both severe acne and transgenderism are inde- differences, says Dr. Campos-Muñoz. In general, female-to-
pendently associated with higher rates of depression and male transgender patients should be given male-oriented treat-
suicide, it may be advisable that, once testosterone treatment ment. Dr. Campos-Muñoz emphasizes that although the poten-
has begun, transgender adolescents are monitored for the tial of conception still exists, “neither antiandrogenic agents nor
appearance of acne, says Dr. Lucía Campos-Muñoz, from the contraceptives can be prescribed because this would conflict
Hospital Clínico San Carlos in Madrid. Given the potential with the masculinization sought”.
risks — some 41% of transgender adults have at some point Isotretinoin is teratogenic so all patients with internal geni-
attempted suicide2 — acne should be treated even if only talia must be warned that pregnancy should be avoided.
mild, she adds. “Such patients may find themselves in testosterone-associ-
Dr. Campos-Muñoz has some experience in treating such ated amenorrhea and may therefore believe they cannot become
patients. Between 2016 and 2017, five female-to-male trans- Transgender CONTINUED ON PAGE 11
As both severe acne and transgenderism are independently associated with higher
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rates of depression and suicide, it may be advisable that, once testosterone treatment U
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has begun, transgender adolescents are monitored for the appearance of acne. E

2
0
Dr. Lucía Campos-Muñoz 1
8
Hospital Clínico San Carlos, Madrid
9
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