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13.4 Which Technique to Use and Why?
https://t.me/medicina_free
Lasers and Energy-Based Devices
Intense pulsed light (IPL) targets vascular and pig­mented lesions, and thus is quite effective at treating poikiloderma of Civatte, with over 80% of patients in one study showing a marked 75 to 100% clearance after three or fewer treatments spaced 1 month
18,19
apart. bruising, as well as stripingand persistent hypo­pigmentation due to imprecise technique or inap­propriate energy settings, res pective l y.
laser and 532-nm potassium titanyl phosphate (KTP) and lithium triborate (LBO) lasers are eec­tive in improving the appearance of dilated blood vessels but are not as eective at targeting pig­mented lesions.
ing the 1,927-nm thulium laser, 1,540-nm erbium­glass fiber laser, 1,550-nm erbium-glass fiber laser, and Q-switched 1,064-nm Nd:YAG (neodymium:yt­trium aluminum garnet) laser can also address neck dyschromia. lasers selectively damage the dermal vasculature in poikiloderma in two ways. First, these wavelengths target water, a main component of blood, likely caus­ing subsequent microvascular destruction. Second, microthermal zones of injury within the dermis also likely aect dermal vasculature. 1,550-nm laser wavelength, which targets deeper dermal structures, with the 1,927-nm wavelength, which targets the epidermal and superficial dermal structures, is thus particularly eective in treating dyschromia, hyperpigmentation, and texture. The Fraxel Re:Store DUAL (Solta Medical, Bothell, WA) utilizes both these wavelengths and is an increas­ingly popular treatment choice for poikiloderma of Civatte. Typically, three or more treatments, spaced 4 to 6 weeks apart, are needed for notic eable resul ts. Patients should be counseled on common side eects with nonablative fractional photo thermol ysis, such as swelling, erythema, discomfort, and mild scaling. Fractional photothermolysis may also be combined with IPL, Q-switched, or picosecond lasers to achieve even better pigmentary improvement in the treatment of poikiloderma of Civatte.
Side eects include swelling, erythema, or
18,19
Vascular lasers such as the 595-nm pulsed dye
20,21
Nonablative fractional photothermoly sis, includ-
22,23,24
Behroozan et al sugge st that the se
22
Combining the
attachments, and the downward pull of the platysma.
25
Horizontal necklines are found in nor­mal physiology and can be observed at any age, in­cluding younger patients at rest. As the neck ages, horizontal necklines become more prominent. A validated 5-point assessment Transverse Neck Lines Scale (Table 13.1) can be used when evaluating a patient for horizontal necklines, with values ranging from none (no transverse necklines) to extreme (noneaceable transverse neck furrows with redun­dant skin; Fig. 13.1).
25
Neuromodulators
When injected directly into horizontal necklines, neuromodulators relax the downward pull of the platysma. Neuromodulators do not address skin laxity and thus when administered alone can be suboptimal in treating horizontal necklines. Botu­linum toxin A injections of 1 to 2 units spaced 1 to
1.5 cm apart along the lines may create an im­provement and satisfaction rate of up to 50%. From our clinical experience, injection of botuli­num toxin A along the platysma bands may also create a small eect on horizontal lines. Yet, when combined with other methods such as dermal fill­ers, botulinum toxin A can play a successful role in significantly decreasing the horizontal neckline
27
size.
Fillers
Dermal fillers lessen the appearance of horizontal necklines by addressing volume loss. Calcium hy­droxylapatite (Radiesse; Mer z North America, Inc., Raleigh, NC) diluted 1:1with 1% lidocaine can be injected between the dermal and subde rmal
Table 13.1 Five-point Allergan Transverse Neck Lines Scale as adapted by Jones et al
0 None: no transverse necklines
1 Minimal: superficial transverse necklines
2 Moderate: moderate, effaceable transverse
necklines
25
26
13.4.2 Horizontal or Transverse Necklines
Horizontal or transverse necklines are caused by a combination of skin laxity, underlying fascial
3 Severe: deep, noneffaceable transverse
necklines
4 Extreme: noneffaceable transverse neck
furrows with redundant skin
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Fig. 13.1 A patient with prominent horizonal necklines showing (a) frontal and (c) la teral pretreatment views and (b) frontal and (d) lateral posttreatment views after one treatment of Belotero hyaluronic acid fillers injected intradermally to horizontal necklines followed by 6 mL of hyperdiluted Radiesse calcium hydroxylapatite injected subdermally 4 weeks later. (Reproduced with permission of Sara Hogan, MD.)
junction along the horizont al necklines or throughout the neck in a fanlike manner with a 25- or 27-gauge cannula.
28,29
Soft malleable hya­luronic acid fillers (Belotero Balance, Merz North America, Inc.; Belotero Soft; Merz North America, Inc.; Restylane Silk, Q-Me d AB, Uppsala, Sweden; Teosyal RHA 2; TEOXANE SA, Geneva, Switzer­land; Juvederm Volbella XC; Allergan, Inc., Dublin, Ireland) injected in the dermal plane have dem­onstrated continued ecacy of up to at least 36 weeks in the literature.
27,30,31,32
Patients should be counseled on potential side eects of filler injection, including redness, itching, bruising, swelling, and, rarely, nodule formation.
30
Nodule formation is most often due to superficial place­ment of fillers.
Lasers and Energy-Based Devices
Ablative fractional CO2laser has been used to signif­icantly improve the appearance of horizontal neck­lines, with results lasting 1 year posttreatment after a single treatment. The therapeutic window is nar­row, however, bringing to question whether benefit outweighs the risk of scarring. tional 1,440- or 1,550-nm lasers may be considered an alternative approach to decrease the risk of scar­ring. Laser treatment may also be combined with neuromodulators, which are typically administered 1 week beforehand.
34
Microfocused ultrasound with visualization (MFU-V) and monopolar capacitive-coupled radio­frequency (MRF) can decrease the appearance of
33
Nonablative frac-
148
13.4 Which Technique to Use and Why?
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horizontal necklines by inducing neocollagenesis and improving skin laxity.
27,29
Both MRF and MFU-V can be combined safely with subsequent same-day dermal filler use for neck rejuvenation. In one study, MFU-V (Ultherapy; Ulthera, Inc., Mesa, AZ) with subsequent same-day injection of diluted calcium hydroxylapatite (Radiesse; Merz North America, Inc.) decreased the Transverse Neck Lines Scale scores from an average of 2.6 at baseline to 1.3 at 90 days posttreatment.
29
13.4.3 Platysmal Banding
Vertical necklines are caused by chronic contrac­tion of the platysma muscle in the setting of in­creasing skin laxity.
35
Younger patients are able to create platysmal bands with active contraction, which disappear at rest. When evaluating a patient for platysmal banding, a validated 5-point Dynam­ic Platysmal Band Photonumeric Assessment Scale (Table 13.2) can be used with scores ranging from no relevant prominence of platysmal bands to very severe prominence of platysmal bands (Fig. 13.2).
35
Neuromodulators
Brandt and Bellman first described botulinum tox­in A as a treatment for platysmal bands in 1998. Neuromodulators are a safe and noninvasive approach to decrease platysmal bands; however, the treatment eect is temporary lasting 2 to 4 months. Early studies endorsed high doses of botulinum tox­in A, with up to 250 of onabotulinum-equivalent units being used. The most recent consensus, however, is that no more than 100 units be in­jected into the platysma given the potential for side eects. achieved with doses of as little as 28 to 36 units
Table 13.2 Five-point Dynamic Platysmal Band Photo­numeric Assessment Scale as adapted by Geister et al
0 No relevant prominence of platysmal bands
1 Mild prominence of platysmal bands
2 Moderate prominence of platysmal bands
3 Severe prominence of platysmal bands
4 Very severe prominence of platysmal bands
37,38
In fact, excellent results can be
35
of onabotulinum-equivalent units. Safe injection technique involves pinching the skin and underly­ing platysmal bands upward and away from other neck structures. Two to three onabotulinum toxin­equivalent units are then injected every 1 to 1.5 cm vertically along each band.
39
Studies show a mean 2-point improvement on the Dynamic Platysmal Band Photonumeric Assessment Scale by day 14, which decreases to 1.2 points by 3 months. most common side eect is bruising. Prolonged dysphagia and neck weakness are most frequently seen in doses higher than 100 units, but can still oc­cur rarely at lower doses.
38,40
When combined with lasers, neuromodulators may be administered the same day as vascular and pigment lasers, 1 week after nonablative fractional lasers, and 3 weeks after ablative fractional lasers.
34
The Nefertiti lift targets the platysma to redefine the jaw line while also improving the appearance of the neck. First described by Levy, the Nefertiti lift involves injecting 30 to 40 total onabotulinum­equivalent units along the lower mandible and the upper platysmal bands. The resulting release of the downward pull from the platysma muscle improves the sight of platysmal bands while also contouring the lower face.
41
The original technique addresses only posterior platysma fibers, creating mandibular contour improvement in mostly lateral views only.
36
The modified Nefertiti lift reported by De Almeida et al also targets anterior platysma fibers and incorpo­rates two lines of mandibular injections points along the entire mandible, improving mandibular contour in both lateral and anterior views.
42
Finally, the Microbotox technique, first described by Wu in 2015, involves approximately 150 injec­tions of botulinum toxin A into the superficial der­mis in a gridlik e pattern across the anterior neck and mandible. When compared to the Nefertiti lift, the Microbotox technique is less effective at targeting platysmal bands but may play a better role in target­ing jowls and soft-tissue laxity.
43
13.4.4 Skin Laxity
Laxity in the lower face and neck both contributes to the aging neck. Mild forms of laxity present as rhytids and wrinkles. More severe forms of laxity contribute to jowls and submental sagging with the formation of a convex cervicomental angle. validated Fasil Face and Neck Laxity Grading Scale is used to evaluate laxity in the upper, middle, and lower face and upper neck.
45
Table 13.3 contains
40
The
44
The
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Fig. 13.2 A 58-year-old woman showing (a) frontal and (c) lateral views of the platysmal bands pretreatment and (b) frontal and (d) lateral posttreatment views 2 weeks following botulinum toxin injections. (Adapted from Nahai F,
Nahai F, ed. The Art of Aesthetic Surgery: Principles and Techniques. 3rd ed. New York, NY: Thieme; 2020.)
a modified version of the scale to highlight the clin­ically relevant portions for neck rejuvenation.
Dermal Fillers
Dermal fillers stimulate collagen production to de­crease skin laxity. Calcium hydroxylapatite (Radiesse,
150
Merz North America, Inc.), when hyperdiluted with 1% lidocaine and injected into the neck and décollet­age, shows histopathologic evidence of increased collagen, elastin, and angiogenesis, even 7 months postinjection. two to three sessions spaced 1 to 2 months apart for maximum results in biostimulation and skin tight-
46
Consensus recommendations advise
13.4 Which Technique to Use and Why?
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ening lasting over 18 months.47Dilution varies with patient skin thickness, with older patients typically requiring greater dilution. For the neck in particular, a dilution of 1:2 or 1:4 is satisfactory for most patients. One syringe per session is generally recom­mended. The filler is in ject ed by cannula vi a retrojec­tion in a fanlike manner at each of three to five entrance points or alternatively with serial punctu­res using a needle creating short horizonal lines around the neck.
47
Alternatively , poly-L-lactic acid can be used in a similar fashion to stimulate neocol­lagenesis and has good evidence for treating neck skin laxity. A single treatment can create physician­noted improv ement in neck laxity 60 days posttreat­ment in 81 to 100% of patients.
48
and laser resurfacing, where potential side eects and subsequent recovery time may be worrisome to patients.
The first MRF device (Thermage CPT; Solta Medi­cal, Haywood, CA) was Food and Drug Administra­tion (FDA) approved for periorbital rhytids in 2002 and subsequently FDA approved for all rhytids in
2005. MRF uses electric current transmitted through the neck to create a broad thermal coagu­lation zone from the resistance of the tissues aected. The amount of energy and resulting heat increases with increasing current, tissue resistance, and time of exposure. The system uses superficial cryogen cooling alongside the generated current to create dermal temperatures of 65 to 75 °C while preventing the epidermis from rising above 40 °C
Lasers and Energy-Based Devices
MFU-V and MRF provide another option to tradi­tional methods of skin tightening such as surgical
Table 13.3 Modified Fasil Face and Neck Laxity Grading Scale as adapted by Alhaddad et al
Class 0 Class 1 Class 2 Class 3 Class 4 Class 5
Lower face
Jowls Absent Slightly
noticeable
and thus preventing epidermal damage. Clinical im­provement in upper neck skin laxity is reported in
Table 13.4. Thermage uses a stamping motion
technique, creating short pulses of energy at each
Protruding forward
Protruding forward and downward
45
Forward protrusion with downward sagging
Forward sagging and lateral loss of definition in the neck
Upper neck
Table 13.4 Clinical results using monopolar radiofrequency (Thermage) in neck rejuvenation
Study Design Energy
Alster
Tanzi
Fritz et al
50
51
Platysma bands
Horizontal bands
Prospective, nonrandomized
Prospective, randomized
Absent Absent Slightly
Absent Absent Absent Slightly
level settings
74–134 J/cm
85–135 J/cm
No. of patients
20 6 mo 1 85% of patients had improvement
2
20 4 mo 1 or 2
2
noticeable
Follow-up after final treatment
Prominent Sagging Sagging to the
noticeable
No. of treatments
treatments
Prominent
Significant outcomes
Average physician-reported improvement score of 1.27, where 0=<25%, 1=25–50%, 2 = 50–75%, 3 = >75% improvement
Physician reported improvement 1 treatment: 11% overall improvement 2 treatments: 15% overall improvement
point where bands or folds are no longer distinguishable
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location (Fig. 13.3). Other MRF devices have since been created and rely on dierent delivery methods such as a continuous motion technique (Exilis, BTL Aesthetics, Prague, Czech Republic; Pelleve, Ellman International, Inc., Oceanside, NY) or the use of a subcutaneous probe to completely bypass the epi­dermis and heat the dermis from underneath (ThermiTight, ThermiAesthetics, Southlake, TX).
49
In 2012, MFU-V (Ultherapy, Ulthera, Inc.) gained FDA approval for the noninvasive lift of skin on the neck and under the chin. MFU-V uses focused
Fig. 13.3 A patient presenting with neck skin laxity showing (a) pretreatment, (b) 2 months posttreatment, and (c) 4 months posttreatment views following one treatment with Thermage. (Adapted from Papel I, Frodel J, Holt R et al., ed. Facial Plastic and Reconstructive Surgery. 3rd ed. New York, NY: Thieme; 2009.)
ultrasound waves to create 1 mm lation zones of 65 °C up to 8 mm below the surface of the skin. By combining the technology with vis­ualization, the provider can image the tissue and provide heat at the exact intended depth. The co­agulation zones immediately alter the targeted col­lagen and stimulate neocollagenesis to improve skin elasticity and firmness over time while com­pletely avoiding damage to the epidermal layer. Clinical results with MFU-V are summarized in
Table 13.5 (Fig. 13.4).
3
thermal coagu-
52
Table 13.5 Clinical results using microfocused ultrasound with visualization in neck rejuvenation
Study Design Device No. of
Kerscher
52
et al
Kerscher
53
et al
Werschler and Werschler
Oni et al
55
56
Prospective, nonrandomized
Prospective, nonrandomized
Prospective, nonrandomized
Prospective, nonrandomized
Ultherapy 22 24 wk 1 Gross skin elasticity
Ultherapy with calcium hydroxylapatite filler
Ultherapy 20 1 y 1 treatment,
Ultherapy 103 90 d 1 65.6% of patients
patients
9 48 wk 1 89% of patients with 1
Follow-up after final treatment
No. of treatments
2 passes
Significant outcomes
(Cutometer measurement) significantly improved compared to baseline
improvement in Mer z Aesthetic Scale
95% of patients had physician- and subject­rated improvement 95% of patients were satisfied or very satisfied
reported improvement
58.1% of patients had physician-reported improvement
54
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Fig. 13.4 A patient presenting with neck skin laxity showing (a) pretreatment and (b) 90 days posttreatment views
following one treatment with Ulthera. (Adapted from Few JW Jr. The Art of Combining Surgical and Nonsurgical
Techniques in Aesthetic Medicine. 1st ed. New York, NY: Thieme; 2018.)
In 2019, Alhaddad et al published a prospective, randomized, evaluator-blinded, split-face clinical trial to compare the ecacy and safety of MFU-V and MRF.
45
The primary end point was a dierence in the Fasil Face and Neck Laxity Grading Scale (Table 13.3).
44
Twenty patients had a single treatment of MRF on one side of the face and neck and a single t reatment of MFU-V on the other. There was significant decrease in the Fasil Face and Neck Laxity Grading Scale for both treatments starting at day 30 posttreatment, which was main­tained up to day 180 posttreatment. There was no statistical dierence between sides of the face and neck treated with MRF compared to MFU-V, although as noted by the authors, this study was limited by the small sample size used. One patient had mild erythema on day 30 posttreatment on the MFU-V-treated side, but no erythema, edema, contour irregularity, or bruising were noted at day 90 or 180 posttreatment in any patient. Although not statistically significant, there was a statistical trend toward a less painful experience with MRF as reported by patients when compared to MFU-V.
45
comparison of MFU-V and MRF is summarized in
Table 13.6.
The addition of radiofrequency energy with mi­croneedling allows the delivery of ther mal energy at controlled depths to stimulate neoelastogenesis and neocollagenesis while supporting increased
absorption of topical products and skin remodeling due to the mechanical needling eects. A number of dierent radiofrequency microneedling (RFMN) devices exist and vary in depth of penetration, nee­dle material and diameter, use of insulated versus noninsulated needles, use of monopolar or bipolar energy, and ability to deliver consistent energy throughout an entire treatment with real-time im­pedance monitoring.
59
RFMN has been studied
extensively for skin rejuvenation with excellent
60
results.
When compared to three sessions of 2,940-nm fractional Er:YAG (erbium-doped:yttrium aluminum garnet) laser treatments administered at 1-month intervals, three sessions of RFMN deliv­ered at the same time intervals to treat facial and neck wrinkling produced significantly higher pa­tient satisfaction rates.
61
It was theorized that RFMN created deeper and broader microscopic thermal zones, leading to increased ecacy in skin tightening.
61
RFMN settings for greatest ecacy include thermal energy delivered for 3 to 4 sec­onds at a temperature of 67 °C, 1.3 to 2 mm depth of penetration, and applications spaced 3 to 4 mm
A
60
apart. neck area.
Typically 50 insertions are used for the
62
A single treatment at these settings yielded a 100% response rate in blinded evalua­tions of skin laxity and skin wrinkling of the neck area 6 months posttreatment.
62
Pain can be the
most treatment-limiting side eect. Other side
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Table 13.6 Comparison of monopolar capacitive-coupled radiofreq uenc y and microfocused ultrasound with visualization
Mechanism of action
Invasiveness Noninvasive Noninvasive
Indications Mild to moderate skin laxity Mild to moderate skin laxit y
No. of treatments Usually one treatment Usually one treatment
Procedure length 30–90 min 60–90 min
Adverse effects Transient mild erythema, edema, burns,
Efficacy Comparable to MFU-V Comparable to MRF
Advantages May be less painful than MFU-V Depth can range from 1.5 to 4.5 mm, able to
Disadvantages Depth limited as it must transmit through
57,58
Monopolar capacitive-coupled radiofrequency (MRF)
Tissue resistance-induced thermal coagulation zone from current source
nerve damage/neuropathy, and scarring possible
tissue, no visualization of area targeted, and poorer results in high BMI patients and patients who smoke
Microfocused ultrasound with visualization (MFU-V)
3
thermal coagulation zones created by
1mm focused ultrasounds
Transient mild erythema, edema, tingling, and tenderness, nerve damage/neuropathy, and scarring possible
visualize area affected with ultrasound, and thermal coagulation zones can be more precise
Poorer results in high BMI patients and patients who smoke
Durability of results
Absolute contraindications
Abbreviations: BMI, body mass index.
12–24 mo 12- to 18-mo treatment intervals for
Patients with cardiac pacemakers or other active implants and pregnant women
eects for RFMN are mild and transient and in­clude erythema, swelling, purpura, and postin­flammatory hyperpigmentation.
60
Dermarolling, Microneedling, Chemical Peels, and Platelet-Rich Plasma
Other treatments for skin laxity exist, but target mild laxity in the form of rhytids and wrinkling. Studies examining the benefits of chemical peels in neck dyschromia, namely, Jessner or 70% gly­colic acid and 40% t richloroacetic acid peels, also noted decreased wrinkling when used on the
15,16
neck.
Similar f indings were also seen with
maintenance (up to 24 mo in select populations)
Patients with cardiac pacemaker or other active implants are candidates except over area of implant, and pregnant women
three sessions of platelet-rich plasma injections into the face and neck spaced 1 month apart, with 52% of patients stating t heir wrinkles had
63
improved.
Dermarolling and microneedling without radiofrequency can be used to treat tex­tural change, with almost 90% of patients seeing noticeable results after two treatments.
64
13.4.5 Submental Fat and Fullness
In the American Society for Dermatologic Surgery 2019 Consumer Survey on Cosmetic Dermatologic Procedures, 73% of consumers were bothered by excess fat under the chin and neck. adipose tissue is less likely to respond to traditional
65
Submental
154
13.4 Which Technique to Use and Why?
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diet and exercise and thus, noninvasive submental contouring can have profound eects on neck reju­venation. Submental fat is divided into two com­partments: subcutaneous or preplatysmal fat and subplatysmal or postplatysmal fat. Nonsurgical submental contouring typically targets subcuta­neous fat alone as subplatysmal fat removal could lead to concavity.
66
Patients with large am ounts of sub platysmal fat, however, may not experience significant improvement when using noninvasive methods co mpared to more invasive, deeper methods of fat removal. Furthermore, patients should be examined for digastric muscle hyper­trophy, subm andibular salivary gland ptosis, and cervical lymphadenopathy, as these may be mis­taken for submental fat and are not amenable to noninvasive therapies.
8
Deoxycholic Acid
Deoxycholic acid was first FDA approved in 2015 for targeting moderate to severe submental fat. Classically known at ATX-101, but now clinically sold as Kybella in the United States and Belkyra in Canada (Allergan Bio-pharmaceuticals, Inc, West­lake Village, CA), the drug is a synthetic compound identical to endogenous deoxycholic acid, a secon­dary bile acid created in the intestine for emulsifi­cation of fat. injections of 1 to 2mg/cm like fashion causing adipocytolysis and removal of excess submental fat. spaced 1 to 3 months apart may be required for a desired result to be noted. Patients with an active
67
ATX-101 is administered in multiple
2
under the chin in a grid-
68
Three to six treatments
submental infection should not be considered for deoxycholic acid (Fig. 13.5).
Clinical results of deoxycholic acid are summar­ized in Table 13.7. Commonly reported out­comes include a greater than 1 point improvement in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), the Patient-Reported Submental Fat Rating Scale (PR-SMFRS), or a combination of the two when compared to baseline (Table 13.8). The first phase III clinical trial by Rzany et al in 2014 used a maximum of four treatments and both 1 and 2 mg/cm
2
concentrations were used with a trend toward greater ecacy with the higher dose, although the trial was not conducted to compare the two doses. the higher concentration of 2 mg/cm mum of six treatments with excellent ecacy.
69
REFINE-1 and REFINE-2 trials used
2
and a maxi-
70,71
Although up to six treatments were allowed, post hoc analysis from pooled trial data showed that sig­nificant improvements were achieved after only two to four treatments.
72
In the Condition of Sub­mental Fullness and Treatment Outcomes Registry (CONTOUR) study, a prospective, multicenter, non­interventional study of 570 patients receiving sub­mental deoxycholic acid injections, 25 and 30% of patients who achieved their treatment goals did not have improvement of greater than 1 point on CR-SMFRS and PR-SMFRS, respectively.
73
Therefore, patients can be satisfied with treatment even with­out reaching the end points used in clinical trials.
Side eects of deoxycholic acid are generally mild to moderate in severity. Among the clinical studies, nearly all side eects resolved by study end. The most frequent side eects include pain,
Fig. 13.5 A patient presenting with submental fullness showing (a) pretreatment and (b) posttreatment views following treatment with Kybella injections. (Adapted from Gerecci D, Perkins S. The graduated approach to surgical neck contouring. Facial Plast Surg 2019;35(5):516–524.)
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% with 1
improvement on
%with≥ 1
improvement on
% with 1
improvement on
No. of
treatments
CR-SMFRS and
PR-SMFRS
PR-SMFRS
CR-SMFRS
Not reported
: 67.0%
2
Placebo: 32.4%
1 mg/cm
: 59.2%
2
Placebo: 23.0%
1 mg/cm
by28±5d
: 73.6%
2
2 mg/cm
: 65.3%
2
2 mg/cm
intervals
: 70.0%
2
Placebo: 18.6%
2 mg/cm
: 82.3%
2
Placebo: 38.5%
2 mg/cm
: 79.1%
2
Placebo: 36.2%
2 mg/cm
by28±5d
intervals
: 66.5%
2
Placebo: 22.2%
2 mg/cm
: 78.4%
2
Placebo: 37.8%
2 mg/cm
: 77.9%
2
Placebo: 34.5%
2 mg/cm
by28±5d
intervals
: 88.0% Not reported Not reported
2
2 mg/cm
by at least 1 mo
apart
Not reported
12 wk: 83.8%
12 mo: 80.7%
12 wk: 86.8%
12 mo: 90.4%
1–6, separated
by ~1 mo
Not reported
Out of patients who
Out of patients who
met treatment
goals: 70%
met treatment
goals: 75%
separated by on
average 8.9–16.7
Out of patients who
Out of patients who
wk between
did not meet
did not meet
treatments
treatment goals:
48%
treatment goals:
58%
(Continued)
156
Table 13.7 Clinical results using deoxycholic acid in the submental region
Dosage Follow-up
Study Design No. of
after final
treatment
patients
12 wk 1–4, separated
,
2
and 2 mg/
Placebo,
1 mg/cm
: 119
: 121
2
2
2 mg/cm
Placebo: 122
1 mg/cm
Multicenter,
randomized,
double-blind,
69
Rzany et al
2
cm
placebo
12 wk 1–6, separated
Placebo,
Placebo: 250
controlled
Multicenter,
REFINE-1:
2
2 mg/cm
: 256
2
2 mg/cm
randomized,
double-blind,
placebo
71
Jones et al
12 wk 1–6, separated
Placebo,
Placebo: 258
controlled
Multicenter,
REFINE-2:
2
2 mg/cm
: 258
2
2 mg/cm
randomized,
double-blind,
placebo
70
Humphrey et
al
5–7wk 1–6, separated
2
: 100 2 mg/cm
2
2 mg/cm
controlled
Single-center,
74,
Shridharani
single-arm,
open label
75
12 wk and
12 mo
2
: 165 2 mg/cm
2
2 mg/cm
Multicenter,
single-arm,
76
Beer et al
12 mo 1–5 treatment,
570 Not
open-label
Multicenter,
73
CONTOUR:
reported
single-arm,
open-label
Behr et al