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13.4 Which Technique to Use and Why?
https://t.me/medicina_free
% with ≥1
improvement on
CR-SMFRS and
PR-SMFRS
Mild SMF
Placebo: 6.7%
ATX-101: 61.3%
Extreme SMF
Placebo: 13.3%
ATX-101: 89.3%
%with≥ 1
improvement on
PR-SMFRS
Mild SMF
Placebo: 33.3%
ATX-101: 67.7%
Extreme SMF
Placebo: 46.7%
ATX-101: 89.3%
% with ≥1
improvement on
CR-SMFRS
Mild SMF
Placebo: 20%
ATX-101: 72.2%
Extreme SMF
Placebo: 26.7%
ATX-101: 96.4%
90% Not reported Not reported
Table 13.7 (Continued) Clinical results using deoxycholic acid in the submental region
No. of
Dosage Follow-up
Study Design No. of
treatments
after final
treatment
patients
at least 28 days
12 wk 1–6 treatments
2
Placebo,
2 mg/cm
93
Mild SMF
Multicenter,
randomized,
77
Glogau et al
apart
Placebo: 16
ATX-101: 31
Extreme SMF:
Placebo: 16
double-blind,
placebo
controlled
ATX-101: 30
spaced ~2 mo
12 wk 1–4 treatments
2
50 3 mg/cm
Single-center,
single-arm,
78
Shome et al.
2019
apart
open label
Abbreviations: CR-SMFRS, Clinician-Reported Submental Fat Rating Scale; PR-SMFRS, Patient-Reported Submental Fat Rating Scale.
157
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Table 13.8 Submental Fat Rating Scales (SMFRS) used
as outcomes in REFINE-1 and REFINE-2 trials
Grade Clinician-
reported
(CR-SMFRS)
0 Absent No chin fat at all
1 Mild A slight amount of chin fat
2 Moderate A moderate amount of chin fat
3 Severe A large amount of chin fat
4 Extreme A very large amount of chin fat
Patient-reported (PR-SMFRS)
70,71
hematoma/bruising, edema, anesthesia/numbness,
and erythema. In the REFINE clinical trials, more
serious, but temporary, side effects seen included
marginal mandibular nerve injury (4.3% of patients),
dysphagia (1.9% of patients), skin ulceration (0.2% of
patients), and injection-site alopecia (0.4% of pa-
70,72
tients).
In practice, marginal mandibular nerve
injury can mostly be avoided by ensuring no injections are within 1.0 to 1.5cm of the inferior mandibular border.
66
Skin ulceration can also be avoided by
ensuring appropriate injection technique by avoiding
superficial injections placed in the dermis. Although
rare in the clinical trials, real-world experience of 39
men receiving deoxycholic acid had 9 men (23.1%)
with injection-site alopecia lasting 6 weeks to 12
months, showing that this side effect may be more
common than previously reported.
74
Off-label, deoxycholic acid can be used to target
the jowls in certain populations with good results.
A recent single-site prospective study treated 66
adults with excess jowl fat with deoxycholic acid
at a dose of 2 mg/cm
2
with a mean 1.8 treatments
spaced, on average, 8.6 weeks apart. Improvement
in jowls was noted in 65 (98%) of patients. Common side effects included edema, numbness, pain,
and bruising. As it is rare to have increased jowl fat
without associated submental fullness, the use of
deoxycholic acid in jowls is intended to be done in
conjunction with treatment of submental fat. All
patients within the study had the submental area
treated with deoxycholic acid injections prior to or
at the same time as the jowl area.
79
Cryolipolysis
Cryolipolysis (CoolSculpting, Zeltiq Aesthetics/
Allergan, Pleasanton, CA) is a noninvasive
temperature-based treatment targeted at permanent localized fat reduc t ion. CoolSculpting
secured FDA approval for cryolipolysis for the
submental area in 2015. Patients with a history
of cold agglutinin disease, cr yoglobulinemia, or
paroxysmal cold hemoglobinuria should not be
considered for cryolipolysis.
Clinical results are summarized in ▶ Table 13.9.
Submental cryolipolysis treatment parameters in
studies vary and involve one or two separate
treatments, but outside of clinical trials, three
treatments spaced 6 to 10 weeks apart may be
necessary, with full results not appearing until
after 4 months.
68
Unlike with ATX-101, there is
no consensus of outcome measures and therefore
a variety of tools have been us ed including calipers, 3D imaging, radiographic imaging including
magnetic resonance imaging (MRI) or ult rasound,
and physician’s and patient’s subjective evaluations.
Mean fat layer reduction by caliper or radiographic
imaging ranges from 1.78 to 4mm. Calculation of total fat volume reduction has been attempted; however, the two studies using 3D imaging to calculate
this significantly differed in outcomes, likely secondary to the absence of a standardized area of which
80,81
to calculate the volumes from.
Even without
standardization of outcome s, the vast majority of patients were ultimately satisfied with the treatment
and reported at least some improvement.
Side effects of cryolipolysis are generally mild
and include localized erythema, bruising, edema,
80,85
numbness, paresthesia, and mild pain.
Neuropathic pain extending outside treatment area and
lasting up to 1 week has also been reported.
86
Comparison of deoxycholic acid and cryolipoly-
sis as treatment for submental fat is presented in
▶ Table 13.10. Additionally, cryolipolysis can be
combined with deoxycholic acid, with cryolipolysis used first used to reduce the bulk of adipose tissue and deoxycholic acid injections subsequently
used to target the remaining areas and sculpt the
submental area as needed.
87
Laser and Energy-Based Devices
Laser lipolysis uses laser energy to liq uefy adipocytes
with the added benefit of stimulating collagen.
Lasers showing efficacy in the submental region include but are not limited to 980-nm diode, 1,470nm diode, and 1,440-nm Nd:YAG lasers.
1,060-nm diode laser (SculpSure; Cynosure, Westford, MA) was FDA approved for lower face and neck
88,89,90,91
A
158
Patient-reported
https://t.me/medicina_free
results
13.4 Which Technique to Use and Why?
(Continued)
Pleased with results:
76%
Not reported
Reported at least
“some improve-
ment”: 100%
Satisfaction rate: 93%
results
Follow-up Objective
No. of
treatments
parameters
Device Treatment
mean volume
One treatment 12 wk 3D imaging:
45-min treatment
with a maximum
CoolSculpting
reduction:
cooling
System, Allergan
3
fat layer reduc-
tion of 2.3 mm
3D imaging:
mean reduc-
tion in fat
22.30 cm
mean reduc-
tion in meas-
ured region:
−31.1%
fat layer reduc-
tion of 4 mm
Ultrasound:
mean fat layer
reduction of
2.8 mm
thickness of
3.77 mm
Mean volume
reduction:
3
4.82 cm
12 wk Caliper: mean
temperature of
USA Ltd, Dublin,
–11 °C, one cycle
Ireland
One treatment 3 mo Ultrasound:
45-min
treatment,
temperature not
CoolSculpting
System, Allergan
One treatment 8 wk Caliper: mean
stated, two cycles
45-min duration
at a cooling
temperature of
−11 °C, two
cycles
CoolSculpting
System, Zeltiq
Aesthetics
Two treatments
spaced 6 wk
–11 °C, 45-min
cooling cycles, 2
CoolSculpting
apart
cycles except for
system; ZELTIQ
2 patients
receiving 1 cycle
Aesthetics
for second
treatment
35 CoolMini applicator,
patients
Retrospective,
nonrandomized, and
open label,
81
Table 13.9 Clinical results of submental cryolipolysis
Study Design No. of
Jain et al
20 CoolMini applicator,
interventional cohort
study
Prospective, single-
center, nonrandomized,
and open label
82
de Gusmão
et al
10 CoolMini applicator,
interventional cohort
study
Prospective, single-
center, nonrandomized,
and open label
interventional cohort
study
83
Suh et al
14 CoolMini applicator,
Prospective, single-
center, nonrandomized,
and open label
80
Bernstein
and Bloom
interventional cohort
study
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Patient-reported
Follow-up Objective
No. of
Satisfaction rate: 80%
results
results
12 wk Caliper: mean
Two treat-
treatments
First treatment:
parameters
fat layer
reduction:
ments spaced
10 wk apart
−12 °C, 45-min
cooling cycle,
3.2 mm
one cycle
MRI: mean fat
Second treat-
layer reduction
ment: −15 °C,
of 1.78 mm
30-min cooling
cycle, one cycle
Satisfaction rate: 83%
mean fat layer
reduction of
2mm
12 wk Ultrasound:
Two
treatments
spaced 6 wk
apart (one
−10 °C, duration
60 min, one
cycle
patient had
one treatment
only)
volume applicator,
CoolSculpting
System, ZELTIQ
Aesthetics,
center, nonrandomized,
and open label
interventional cohort
study
et al
Table 13.9 (Continued) Clinical results of submental cryolipolysis
Device Treatment
patients
Study Design No. of
15 Prototype small-
Prospective, single-
84
Leal Silva
160
Pleasanton, CA
applicator,
60 CoolMini
Multicenter,
prospective, open label,
85
Kilmer et al
CoolSculpting
nonrandomized
system, ZELTIQ
interventional cohort
Aesthetics
study
Abbreviations: MRI, magnetic resonance imaging; 3D, three-dimensional.
13.5 Conclusions
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Table 13.10 Comparison of deoxycholic acid (ATX-101) and cryolipolysis
Deoxycholic acid (ATX-101) Cryolipolysis
Mechanism of action Bile acid-induced adipocyte membrane
destruction
Invasiveness Minimally invasive Noninvasive
Indications Moderate to severe submental fat Submental fat in patients with a BMI
Number of treatments Up to 6 treatments with significant
improvements noted at 2–4 treatments
Procedure length 30 min 45 min
Adverse effects Swelling, bruising, discomfort, necrosis,
dysphagia, temporary nerve damage, and
alopecia
Efficacy 61.3–89.3% of patients ≥1 improvement
on CR-SMFRS and PR-SMFRS
Advantages Minimal downtime and controlled
placement
Disadvantages Multiple treatments necessary, cost of
drug, and inability to accurately control fat
reduction
68
Cold-induced adipocyte apoptosis
of ≤ 46.2
1–3 treatments with average of 2
treatments
Swelling, altered sensation, temporary
nerve damage hyperpigmentation, and
neuropathic pain
Mean submental fat thickness decrease
of 1.78–4mm
Minimal downtime and controlled
placement
Multiple treatments may be necessary,
dedicated room for treatment
required, and inability to accurately
control fat reduction
Durability of results Sustained long term (at least 4 y) Permanent
Absolute contraindications Patients with active submental infection Patients with history of cold agglutinin
Abbreviations: BMI, body mass index ; CR-SMFRS, Clinician-Reported Submental Fat Rating Scale; PR-SMFRS, PatientReported Submental Fat Rating Scale.
contouring in 2017. In the supporting prospective,
multicenter non-placebo-controlled study, 57 subjects were treated with up to two 25-minute treatments with SculpSure. Twelve weeks postfinal
treatment, submental fat was reduced by 1.785mm
a reduction of 5.8mm in submental fat thickness as
seen by ultrasound 6 months posttreatment.
effects were mild and self-resolving and included
erythema, edema, and vesicles without scarring or
hyperpigmentation.
disease, cryoglobulinemia, or
paroxysmal cold hemoglobinuria
93
93
and 100% of the patients were satisfied with the
treatment. Side effects were mild to moderate and
transient in all but one case; these included swelling, pain, erythema, numbness, hair loss, bruising,
firmness, and blisters.
92
Radiofrequency is more recently being utilized
to target submental fat. A high-powered monopolar radiofrequency device (truSculpt, Cutera Inc.,
Brisbane, CA) was shown in an exploratory study to
effectively target the submental area with a cycle of
2 minutes at 43°C and 3 minutes at 45°C. Two treatments spaced 1 month apart on 21 patients yielded
13.5 Conclusions
Numerous noninvasive treatments are available
for neck rejuvenation, allowing for significant improvement to be achieved with less recovery time
and decreased risk of adverse effects compared to
surgical approaches. ▶ Table 13.11 summarizes
our approach, which starts by targeting individual
patient’s concerns and selecting treatments to ensure the best patient outcomes. Most often, a combination of treatments is needed in order to
Side
161
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Table 13.11 Summary of noninvasive neck rejuvenation techniques based on primary concern
Dyschromia Horizontal necklines Platysmal
banding
●
Cosmeceuticals
●
Chemical peels:
TCA, Jessner,
glycolic acid
●
IPL
●
Nonablative
fractional laser:
1,550 ±
1,927 nm
●
Neuromodulators
●
Hyaluronic acid filler
●
Diluted calcium
hydroxylapatite
●
Nonablative fractional
laser: 1,550, 1,440 nm
●
Ablative fractional laser:
10,600 nm
●
MFU-V
●
MRF
●
Neuromodulators
Skin laxity Submental
fullness
●
Hyperdiluted calcium
hydroxylapatite
●
Poly-L-lactic acid
●
MFU-V
●
MRF
●
Radiofrequency
microneedling
●
Chemical peels: TCA,
●
Deoxycholic
acid
●
Cryolipolysis
●
MRF
●
Laser lipolysis:
1,060 nm
diode
Jessner, glycolic acid
●
Dermarolling and
microneedling
●
Platelet-rich plasma
Abbreviations: IPL, intense pulsed light; MFU-V, microfocused ultrasound with visualization; MRF, monopolar capacitivecoupled radiofrequency; TCA, trichloroacetic acid.
achieve desired and lasting results. Further studies
are needed to help identify which specific combination treatments work best when used together.
13.6 Expert Commentary by
Dr. Slavin
This is a comprehensive chapter focusing on dyschromia, skin quality, subcutaneous fat, and contour
irregularities of the head and neck. It is written by
pioneers in developing and applying laser technology for cosmetic improvement of the face. In their
meticulous analysis of facial features—from pigmen-
tary issues to loose skin—they give a systematic,
well-organized approach. These techniques are becoming increasingly important for clinicians going
forward. Although the techniques do not replace
surgery, they provide excellent alternatives, particularly in patients who are not surgical candidates.
13.7 Expert Commentary by
Dr. Lin
The authors bring forth their vast experience of
noninvasive approaches of the skin and underlying
structures. They outline the most commonly addressed areas noninvasively, with structures at the
platysmal layer and above, while comprehensively
outlining the treatments available. Using these as
adjunct procedures with procedures addressing the
deeper structures provides an all-encompassing
approach to the neck.
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