ATX-101 (Deoxycholic Acid Injection) Treatment in Men:

Insights From Our Clinical Experience

Sachin M. Shridharani, MD* and Kathleen L. Behr, MD†

BACKGROUND Excess submental fat (SMF), also called as a double chin, is an area of concern for men that
can be addressed clinically. ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in
Canada, Australia, and various European countries) is the first injectable approved for reduction of SMF.

OBJECTIVE To share the authors’ clinical experience using ATX-101 in men with submental fullness and offer
insights regarding how this treatment may be presented to men as an option to improve their submental
profile.

METHODS Retrospective review of the authors’ medical records for male patients treated with ATX-101.

RESULTS To allow for fewer ATX-101 treatments, it is recommended that a large surface area be treated at
the first session. The positive changes and outcomes achieved with ATX-101 build confidence between the
physician and patient, which often leads to male patients seeking other aesthetic treatments to improve their
overall appearance.

CONCLUSION ATX-101 treatment is often an effective introduction to aesthetic medicine for men.

S.M. Shridharani receives writing assistance, medicines, equipment, or administrative support from Allergan.
K.L. Behr receives writing assistance funded by Allergan; is an advisory board member for Allergan; receives
payment for lectures including service on speaker’s bureaus from Allergan; and owns stock in Allergan; and
has received payment for development of educational presentations from Allergan.

I n aesthetic medicine, men are a small percentage of

the patient population. However, according to
statistics from the American Society of Plastic Surgeons,
there was a 24% increase in men undergoing cosmetic
procedures in the United States between 2000 and
2015.1 Of the more than 1.2 million cosmetic
procedures conducted in 2015 in men, approximately
84% were minimally invasive. As men are a growing
part of the patient population in aesthetic medicine, it is
imperative to understand their specific concerns and
how available treatment options can meet their needs.
A 2015 survey among injectable-naive, aesthetically
oriented men found that submental fullness (double
chin) was a major area of concern (second only to hair
loss).2 The presence of excess submental fat (SMF)
reduces the definition of the chin and jawline, and
accumulation of SMF often occurs as men age.3
Another survey conducted in 2015 among both men
and women found that 74% of respondents considered
a male jaw angle concealed by SMF, sagging skin, and/
or a beard to be aesthetically unpleasing.4 In addition to
aesthetic concerns, submental fullness is associated with
a myriad of negative social and psychological percep-
tions by both oneself and others.5–10 Furthermore,
excess SMF can result from a genetic predisposition11
and thus can often be resistant to weight loss strategies
such as diet and exercise. In combination, these data
suggest that SMF is an aesthetic concern among men
that may need to be addressed clinically.
Invasive surgical procedures, such as laser lipolysis,
direct fat excision, and targeted liposuction, have
been the standard of care for improving submental

*Private Practice (LUXURGERY), New York, New York; †Private Practice (Behr Laser and Skin Care Center), Fresno,
California

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
· ·
ISSN: 1076-0512 Dermatol Surg 2017;0:1–6 DOI: 10.1097/DSS.0000000000001306

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
 ATX-101 TREATMENT IN MEN
contour. However, ATX-101 (deoxycholic acid
injection; Kybella in the United States and Belkyra in
Canada, Australia, and various European countries;
Kythera Biopharmaceuticals, Inc., Parsippany, NJ,
an affiliate of Allergan) is the first injectable
approved for improvement of moderate-to-severe
convexity or fullness associated with SMF in
adults.12,13 ATX-101 is a clear, colorless, sterile
liquid supplied in 2-mL single-use vials.12,13 When
injected subcutaneously into fat, the active ingredi-
ent of ATX-101 (deoxycholic acid) disrupts the cell
membrane of adipocytes inducing cell lysis and
stimulating recruitment of inflammatory cells to
clear cellular debris and liberated lipids from the
injection site.14–19 In randomized, placebo-
controlled phase 3 trials conducted in the United
States, Canada, and Europe, ATX-101 treatment
was shown to safely and effectively reduce SMF,
increase satisfaction with the appearance of the
face/chin, and reduce the psychological impact of
SMF.5–8 A subanalysis of data from 2 phase 3 trials
conducted in the United States and Canada dem-
onstrated that 77% of ATX-101–treated men (n =
80)20 achieved a clinically meaningful reduction in
SMF.21 In addition, 79% of men treated with ATX-
101 were satisfied with the appearance of their face/
chin after treatment.20 The objective of this article is
to share the authors’ clinical experience using ATX-
101 in men with submental fullness and offer
insights regarding how this treatment may be pre-
sented to men as an option to improve their sub-
mental profile.
The Male Patient
Men may be unaware of procedures available to
address their aesthetic concerns. Furthermore, men
may be uncomfortable proactively seeking a consul-
tation from a physician. Despite these barriers, the
male market for aesthetic procedures is growing, likely
owing to several factors: greater understanding of
male facial anatomy, an increase in media awareness
of male aesthetics, social acceptability, and referrals by
satisfied patients.
According to the survey conducted in 2015, among
injectable-naive, aesthetically oriented men, 28%
2 DERMATOLOGIC SURGERY
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
would talk to their physician within the next 2 years
about their SMF.2 Regardless of diet and exercise,
SMF can be persistent and men who are concerned
about submental fullness often note a lack of chin and/
or jawline definition, discomfort with collared shirts,
and displeasure with their appearance in photographs.
These reasons are often cited as the driving force for
men seeking treatment to improve their submental
contour.
ATX-101 Treatment in Men
Before initiation of ATX-101 treatment, photographs
should be obtained to document baseline SMF (Figure
1). The preplatysmal SMF should then be palpated to
determine the optimal treatment area. The treatment
area is often midline but can extend laterally as far as
the sternocleidomastoid muscle.22 It is essential to treat
laterally in the on-label region to ensure patients do
not have central neck improvement only. As ATX-101
is a surface area-based treatment, the surface area
dictates the volume of medication while the amount of
SMF determines the number of treatments. To allow
for fewer treatments, it is recommended that a large
surface area be treated at the first session. The treat-
ment area is outlined and a 1-cm injection grid is
placed within the outline to guide the injections
allowing for equal distribution of the medication.
ATX-101 is drawn into a 1-mL syringe with a 30-
gauge (or smaller) 0.5-inch needle. The needle is
inserted perpendicular to the skin at a depth of 0.25 to
0.50 inches next to each marking on the grid and 0.2
mL of medication is injected. Three to 4 vials (6–8 mL)
of ATX-101 are recommended at the first treatment, as
this tends to provide early results, encouraging men to
complete the full treatment course. Using a small
starting dose (1 vial [2 mL]) is discouraged, as this is
likely to be subtherapeutic. Subsequent treatments
typically require less volume of ATX-101, provided
the physician uses requisite amount of drug at the first
treatment. As the SMF pad mass is reduced in size over
time, less medication would be needed at each sub-
sequent treatment.
To maximize patient retention, address patient con-
cerns, and monitor for adverse events (AEs), it is rec-
ommended that patients return to the office 1 week
 SHRIDHARANI AND BEHR

Figure 1. Representative photographs of men treated with ATX-101 for reduction of submental fat (SMF). (A) 36-year-old
male who received 3 ATX-101 treatments (total ATX-101 volume: 24.0 mL; interval between treatment 1 and 3: 294 days).
Patient achieved a 2-grade improvement in SMF based on physician assessment via the validated 5-point Clinician-
Reported SMF Rating Scale (CR-SMFRS). (B) 65-year-old man who received 4 ATX-101 treatments (total ATX-101 volume:
12.6 mL; interval between treatment 1 and 4: 299 days). Patient achieved a 1-grade improvement in SMF based on the CR-
SMFRS. BMI, body mass index.

after ATX-101 treatment. Monthly follow-up is then
recommended to monitor progress and continue
treatment. It is also critical to take photographs during
and after ATX-101 treatment to document progress
(Figure 1). Most men are satisfied after an average of 2
to 3 treatments (Table 1). The positive changes and
outcomes achieved with ATX-101 build confidence
between the physician and patient, which often leads
to male patients seeking other aesthetic treatments to
improve their overall appearance (Table 2).
Adverse Events and Comfort Measures
Several basic measures can be used to help decrease the
usually short-lived discomfort associated with ATX-
101 treatment. Generally, patients take acetamino-
phen 1 hour before the procedure. Ice, alone or in
combination with injectable lidocaine (with epineph-
rine), is administered 5 to 10 minutes before treatment.
Lidocaine or steroids should not be combined with
ATX-101 as there are no studies evaluating the effect
of such additives on the safety and efficacy of ATX-
101. Furthermore, there is concern that local or sys-
temic steroids may inhibit skin retraction as steroids
are known to impede collagen formation.23 Immedi-
ately after treatment, patients ice the submental area at
the office for 5 to 7 minutes.
ATX-101 has a favorable safety profile. Adverse
events associated with ATX-101 treatment include
injection-site tenderness, swelling, bruising, and
numbness (Table 1). Swelling is anticipated and
patients should adjust their schedules accordingly. The
most significant swelling occurs in the first 3 to 8 days
after ATX-101 treatment and is often reduced after
subsequent treatments. To help manage swelling, it is
recommended to have patients aggressively ice the
treated area, keep their head elevated, avoid exercise,
and minimize salt and alcohol intake. In addition,
patients should be encouraged to embrace swelling5–8
as the body’s natural response to the adipocyte lysis
caused by ATX-101.18
Temporary injection-site alopecia was observed in up
to 7% of the male patients. It is hypothesized that the
reason for temporary localized injection-site alopecia
may be shock alopecia secondary to superficial injec-
tion or direct damage to the hair bulb.24 Alopecia
resolves spontaneously and relatively quickly after
completion of ATX-101 treatment (Figure 2). Patients
should be informed before ATX-101 treatment that
they may observe this phenomenon. To date, tempo-
rary alopecia has not deterred patients from com-
pleting their ATX-101 treatment course. Marginal
mandibular nerve paresis was observed in 4 patients

0:0:MONTH 2017 3

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
 ATX-101 TREATMENT IN MEN

TABLE 1. Treatment Characteristics Among Men Who Have Undergone ATX-101 Treatment

Practice Type

Plastic Surgery Dermatology

(N = 65) (N = 16)
Age, mean (SD), yrs 42.8 (10.2) 55.5 (8.6)
Baseline BMI, mean (SD), kg/m2 27.6 (4.1) 26.2 (3.8)
Number of ATX-101 treatments, mean (SD) 1.7 (0.9) 2.3 (0.9)
Interval between ATX-101 treatments, mean 65 (51) 43 (60)
(SD), d
Total volume of ATX-101 administered, mean 13.9 (8.7) 8.8 (3.0)
(SD), mL
Achieved clinically meaningful improvement 72% 71%
in SMF*
Comfort measures used Local anesthesia Analgesics (pretreatment)
Analgesics (pretreatment and Ice (pretreatment and
posttreatment) posttreatment)
Ice (posttreatment)
Injection-site adverse events Tenderness Tenderness
Bruising Bruising
Swelling Swelling
Alopecia Numbness
Nerve paresis

*Clinically meaningful improvement is defined as a $1-grade improvement in SMF from baseline based on assessment via the validated
5-point Clinician-Reported SMF Rating Scale (absent, mild, moderate, severe, or extreme SMF).21
BMI, body mass index; SMF, submental fat.

out of approximately 500 ATX-101 treatments; all
events resolved within 15 to 30 days. A potential
mechanism of nerve paresis is damage to the myelin
sheath surrounding the nerve leading to temporary
demyelination and a period of nerve inflammation. It
is not believed that damage is secondary to a direct
intra-neural injury. In clinical trials, skin laxity was
often unchanged or improved after ATX-101 treat-
ment despite significant reduction of SMF.5–8 In the
authors’ patients, no increase in skin laxity has been
noted after ATX-101 treatment; rather, improved
submental contour is usually apparent after treatment
completion. Data suggest that neocollagenesis occurs
subsequent to ATX-101 treatment,18 which may
contribute to these skin laxity effects. No patients
discontinued ATX-101 treatment because of AEs.

TABLE 2. Aesthetic Procedures Sought by Men After Receiving ATX-101 Treatment

Practice Type

Plastic Surgery (N = 65) Dermatology (N = 16)

Men returning for other aesthetic procedures 45% in first 6 mo 50%
>60% in 1 yr
Types of aesthetic procedures sought by men Liposuction Lasers
Rhinoplasty Injectables
Blepharoplasty Z-plasty
Chin implant
Lasers
Injectables (fillers)
Injectables (botulinum toxins)

4 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

Figure 2. Representative example of injection-site alopecia observed after ATX-101 treatment. (A) 36-year-old man expe-
riencing injection-site alopecia (black arrows) at 18 weeks after his second ATX-101 treatment. (B) Patient at 25 weeks after
his third (and last) ATX-101 treatment, at which time the alopecia had resolved.
Conclusions
Injectable treatments such as ATX-101 are an excel-
lent way to introduce men to aesthetic medicine. Fur-
thermore, successful completion of ATX-101
treatment often leads men to return for other proce-
dures. Physicians must be aware of the unique aes-
thetic goals of men and how to talk to this patient
population. It is important to show men (through
publications and websites) that the physician has
experience working with men and can address their
concerns. It may also be helpful to keep the office and
practice modern and relatively gender neutral so that
men feel comfortable in the reception area, consulta-
tion rooms, and treatment rooms. Staff should be
trained to understand the aesthetic goals of men so
they are able to interact with male patients differently
from both financial and clinical perspectives. ATX-
101 is effective and well tolerated in men and an
excellent tool for introducing men to cosmetic
procedures.
Acknowledgments Writing and editorial assistance
was provided to the authors by Evidence Scientific
Solutions, Philadelphia, PA, and funded by Allergan
plc, Dublin, Ireland. Both authors met the ICMJE
authorship criteria. Neither honoraria nor payments
were made for authorship. Allergan was not involved
in the development of the manuscript with the
authors or the vendor. Allergan had the opportunity
to review the final version of the manuscript and
provide comments; however, the authors maintained
complete control over the content of the paper.
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Address correspondence and reprint requests to: Sachin M.
Shridharani, MD, 880 Fifth Avenue, #1B/C/D, New York,
NY 10021, or e-mail: sms@luxurgery.com