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. 2023 Jan 13;20(2):1522. doi: 10.3390/ijerph20021522

Table 2.

Overview of treatment protocols (device, settings, anaesthetic used), pain, and adverse effects.

Study/n Intervention/Transducers Settings/Lines/Joules
(If Stated)
Anesthetics Pain Adverse Effects Device Used
Alhaddad et al. [8]
N = 20
Target the superficial musculoaponeurotic system of the face
4 MHz, 4.5 mm
7 MHz, 4.5 mm
7 MHz, 3.0 mm
10 MHz, 1.5 mm
A total of 195 lines were delivered to the deeper tissue level, and 205 lines were delivered to the superficial tissue level (one side of the face only) Topical 7%/7% lidocaine–tetracaine topical ointment 2.35 ± 2.0
VAS
(0–10)
One patient developed Grade 1 erythema. Ulthera
Ko et al. [9]
N = 32
n = 32. The sizes of the involved areas were 5.0 × 5.0 cm2 on each cheek
MF1: 7 MHz, 1.5-mm
MF3: 2 MHz, 3.0-mm
MF4: 2 MHz, 4.5-mm
120 shots for the cheek, pulse ranged from 1.0
to 1.5 J distributing a total 537.6 J
Topical anaesthetic cream 3.00 ± 1.6
VAS
(0–10)
Erythema was seen in up to 9.38% mostly subsided within 5 days.
Ecchymosis was seen in up to 6.25% (n = 2) dissolving in 3 days.
Ultraformer III
Oni et al. [10]
N = 103
All treatment areas received 2 passes:
1. Ulthera Deep See 4–4.5 transducer (deeper penetration)
2. DS 7–3.0 transducer (more superficial penetration) for the second pass
Approximately 295 exposure lines were placed on each patient’s face and neck. Oral medications (5–10 mg of diazepam and 5/325 mg of hydrocodone/acetaminophen. Intramuscular medication
(60 mg of ketorolac tromethamine)
Cheeks 5.68
Submental area 6.09
Submandibular region 6.53
NRS
(0–10)
Wheal on cheeks in three patients. Ulthera
Park et al. [11]
N = 20
Patients were treated with a HIFU-tightening device
to the entire face except for the nose and eyes.
4 MHz, 4.5-mm
7 MHz, 4.5-mm
7 MHz, 3.0-mm
Each probe delivered a set of pulses in a linear array at 1 cm intervals. From 400 to 500 shots were delivered according to the size of the face. Topical lidocaine/prilocaine cream
three patients, received a nerve block of the supraorbital, supratrochlear, intraorbital and mental nerves
Not stated Six patients with erythema and swelling, and two patients with purpura and bruising. Resolved within 2 weeks. Ulthera
Werschler et al. [12]
N = 20
Treatments were delivered using a vectored pattern
4.0 and 7.0 MHz at focal depth 3.0 and 4.5 mm.
Subjects received a mean of 683 treatment lines (range 609–700) in the cheeks, submentum, submandibular, peri orbital and brow regions Not stated 4.0 at 4.0 Mhz/4.5 mm
3.2 at 7.0 Mhz/3.0 mm,
5.5 at 7.0 Mhz/4.5 mm
NRS (0–10)
One patient swelling under right eye. Resolved within 4 days. Ulthera
Lee et al. [13]
N = 12
The dermis and subcutaneous tissue were targeted using the 4-MHz, 4.5-mm-focal-depth and 7 MHz, 3.0 mm focal depth probes. 4 MHz, 4.5 mm focal depth (0.75–1.2 J)
7 MHz, 4.5 mm focal depth (0.75–1.05 J)
7 MHz, 3.0 mm
focal depth (0.4–0.63 J
Topical anaesthetic ointment (9% lidocaine) 3.9 ± 1.66
VAS
(0–10)
All subjects developed slight erythema and oedema immediately after treatment. Ulthera
Lu et al. [14]
N = 25
Subjects were treated with MFU-V to the face and neck using 2 different transducers: 4 MHz, 4.5 mm focal depth and 7 MHz, 3.0 mm focal depth with a total of 800 lines. Total 800 lines were given;
4 MHz, 4.5 mm, 0.90 J, 350 lines on the cheeks and neck;
7 MHz, 3.0 mm 0.30 J 430 lines on the forehead temple area, cheeks and neck
7 MHz, 3.0 mm focal depth, 0.30 J, 20 lines on the infraorbital area.
All subjects had topical anaesthesia containing 2.5% lidocaine and 2.5% prilocaine
oral analgesics with ibuprofen 800 mg before the treatment
4.1 (2.0) 4.5 mm
2.7 (1.6) 3.0 mm
VAS
(0–10)
Three soreness, 20 bruising/oedema/erythema, two others (contact dermatitis and submandibular burns). Ulthera
Fabi et al. [24]
N = 48
MFU-V treatment of the face and upper neck using the 4 MHz, 4.5 mm and 7 MHz, 3.0 mm depth transducers. 370–420 treatment lines at the highest energy settings. 10% of subjects received topical application of 23% lidocaine/7% tetracaine
15% received it in combination with oral diazepam (5–10 mg)
The majority of subjects received a combination of topical anaesthesia, oral diazepam (5–10 mg) and an intramuscular injection of 50 to 100 mg of meperidine and 50 mg of hydroxyzine
Not stated One patient showed evidence of a 2 mm white dermal papule on the upper neck. Ulthera
Saket et al. [16]
n = 22
Treatment of brow, forehead, infraorbital rim, lateral orbit, nasolabial folds, prioral and cheeks.
The areas with the thinnest skin treated with superficial depth probes;
the brow and temple treated with superficial and deeper probes;
cheek and submental skin were treated with the deepest 4 MHz 4.5 mm probe followed by additional treatment with a superficial probe.
The energy level set between;
1.5 mm transducer 0.2 and 0.25 J;
3 mm transducer set between 0.5 and 0.7 J;
4.5 mm transducer set between 0.6 and 0.85 J. The number of shots (varied between 600 and 800 lines that seemed covered the whole faces with maximum efficacy.
None used 2.5
NRS 1–5
Not stated UTIMS A1
Alam et al. [17]
N = 35
Subjects treated with a focused intense ultrasound tightening device to the forehead, temples, cheeks, submental region and side of neck using the following probes: 4 MHz, 4.5 mm focal depth; 7 MHz, 4.5 mm focal depth and 7 MHz, 3.0 mm focal depth. On average, 110 exposure lines were placed
using the focused ultrasound system on the face and
neck of each subject.
Topical anaesthetic
Ointment (7%/7%) lidocaine-tetracaine
3–4
NRS
(1–10)
Two early subjects developed elevated white
linear striations of the neck.
Ulthera
Sasaki et al. [18]
Gr. 1
N = 107
Above the superolateral brow, the fibromuscular layer and dermal treatment lines were administered in vertical directions, but these were administered horizontally within crow’s feet sites.
Within the malar bag site, all fibromuscular and dermal
treatment lines were placed in a superomedial direction.
In the face and neck, fibromuscular treatment lines were positioned in a horizontal direction, and dermal treatment lines were placed superolaterally.
423 J to each lateral brow and crow’s feet (7 MHz, 3.0 mm, 15 lines; 7 MHz, 4.5 mm, 15 lines)
461.2 J to each malar bag (7 MHz, 3.0 mm, 15 lines; 4 MHz, 4.5 mm, 15 lines);
1845 J to each half of the face (7 MHz, 3.0 mm, 60 lines; 4 MHz, 4.5 mm, 60 lines);
2306 J to the entire neck (7 MHz, 3.0 mm, 75 lines; 4 MHz, 4.5 mm, 75 lines).
A pain management program was initiated in a graded fashion. It consisted of administering oral analgesic or sedative medication, giving distractive hand and foot massages, reducing skin temperature with an air coolant device, lowering joule settings (by 1 level for each transducer or by shortening the length of treatment lines) and, if necessary, administering selective nerve blocks or limited amounts of buffered lidocaine (subcutaneously) Peri-orbital 5.7
face
3.7
NRS (0–10)
All patients experienced transient erythema for 1 to 2 h and mild swelling for several days. Mild bruising generally resolved within 1 to 2 weeks.
Three patients had transient dysesthesia (numbness or hypersensitivity).
Ulthera
Sasaki et al. [18]
Gr. 2
N = 55
Patients received twice the number of treatment
lines (oppose to gr 1) and, therefore, increased joule energy to each site (except the malar bag area where treatment remained
the same as before).
846 J to each lateral brow and crow’s feet (7 MHz, 3.0 mm, 30 lines; 7 MHz, 4.5 mm, 30 lines);
461.2 J to each malar bag (7 MHz, 3.0 mm, 15 lines; 4 MHz, 4.5 mm, 15 lines)
3690 J to each half of the face (7 MHz, 3.0 mm, 120 lines; 4 MHz, 4.5 mm, 120 lines); (3) 4612 J to the entire neck (7 MHz, 3.0 mm, 150 lines; 4 MHz, 4.5 mm, 150 lines).
Not stated Ulthera
Yalici-Armagan et al. [19]
N = 24
7.5 MHz 3.0 mm and 4 MHz 4.5 mm for treating lower facial and submental laxity. Treatment was performed by 2 dermatologists following the manufacturer’s recommended protocol. Cheeks and submentum: 4.5 mm; 0.9 to 1.2 J and 3.0 mm 0.35 to 0.45 J.
Mean treatment line 262 ± 29.7 (range 217–335).
No numeric measurement One subject reported transient stinging sensation/dysesthesia on the face after the procedure that lasted approximately 6 months. Another subject reported erythema and striation after application. Microson (Cosmoplus Co., Sungnam, Korea)
Friedman [20]
N = 43
IFUS treatment of neck and lower facial skin laxity The submental region, cheeks 4 MHz, 4.5 mm probe (1.2 J) and 7 MHz and 3.0 mm probe (0.65 J) Topical anaesthetic ointment
(lidocaine 2.5% and prilocaine 2.5%)
oral 1 g acetaminophen
No numeric measurement
4 MHz, 4.5 mm probe was painful at times
Erythema and oedema were acute and transient responses. No numbers mentioned. Doublo IFUS (Doublo™, HIRONIC Co.)
Araco [21]
N = 50
The lower lids, zygomas, cheeks, submental area and mandibular lines were treated.
4.5 mm superficial muscular 3.0 mm aponeurotic system
1.5 mm subcutaneous tissue
deep dermis
4 MHz (0.9 J) 4.5-mm
7 MHz (0.3 J) 3.0-mm
10 MHz (0.25 J) 1.5-mm
All patients received 1200 spot lines 400 lines from each transducer at recommended energy power
Lormetazepam 2 mg, tramadol 25 mg and local lidocaine cream 3.32 ± 1.15
PPSR (10-point scale not validated)
Not stated Ulthera
Wanitphakdeedecha et al. [22]
N = 34
Patients were treated with a single session of MFU with 2.0 mm (5.5 MHz) transducer at the forehead, lateral and just below the eye area. Total of 140 lines at 0.2–0.4 J;
Forehead 90 horizontal
lateral eye area five horizontal and vertical
under eye area15 horizontal
Topical anaesthetic cream 3.03 ± 1.57
VAS
(0–10)
All patients developed mild erythema immediately after the treatment with spontaneously resolved at 1-week follow-up. Ultraformer III
Shome et al. [23]
N = 50
Patients were treated
3.0 mm for deep dermis
4.5 mm for superficial muscular aponeurotic system.
7.5-MHz 3.0-mm
forehead, 0.3 to 0.35 J;
malar, 0.35 J;
temple, 0.35 J.
cheeks, submental areas; 4.4 MHz, 4.5 mm at 1.2 J;
7.5 MHz with the 3.0-mm 0.45 J.
+/−500 exposure lines (range: 480–700)
Topical anaesthetic ointment (7%, lidocaine–prilocaine) 32% mild pain;
48% moderate pain,
20% severe pain
(10-point scale (0 = no pain; 1–4 = mild pain; 5–8 = moderate pain; 9–10 = severe pain)
Almost all the patients had swelling that persisted for 2 to 14 days. Ulthera