New Ultherapy method: Utilizing novel surgical and anatomical concepts yields outstanding results

Abstract

Background
Micro‐focused ultrasound (MFU) is a technique for skin rejuvenation and lifting, targeting the facial SMAS—a fibrous network encompassing the platysma muscle and parotid fascia.

Objective
This study aims to propose a novel and cost‐effective method (suggested by Fatemi) for Ultherapy, comparing its effectiveness with the conventional approach.

Materials and Methods
A prospective double‐blind clinical trial was conducted with 30 female volunteers randomly assigned to two groups: The control group (conventional method) and the experimental group (new method). Ultherapy procedures utilized MFU technology with low energy and a higher frequency.

Results
Statistically significant differences in lifting effects and improvement in skin laxity were observed between the two groups. The new method, with a focus on the parotideal area of the SMAS, demonstrated superior outcomes and higher patient satisfaction.

Conclusion
The parotideal region's accessibility, increased thickness, and safety profile make it an ideal target for Ultherapy. This not only reduces the risk of nerve injury but also yields effective collagen remodeling and skin‐lifting results.

Full text

2882
|
J Cosmet Dermatol. 2024;23:2882–2887.wileyonlinelibrary.com/journal/jocd
1 | INTRODUCTION
Micro- focused ultrasound (MFU) represents a focused ultrasound
therapy employing low energy levels (0.4–1.2 J/cm2) in comparison
to high- intensity focused ultrasound (HIFU), an ablative modal-
ity that operates with high energy (47–59 J/cm2) primarily used for
tumor destruction. The only indication of HIFU in dermatology is for
body sculpting and ablation of fat tissue. Operating at a frequency
of approximately 2 MHz, HIFU penetrates the skin to a focal depth
of 1.1–1.8 cm for subcutaneous fat ablation.1
For skin rejuvenation and lifting, we utilize MFU with low energy
(0.4–1.2 J/cm2) and a higher frequency (4–10 MHz), facilitating skin
penetration of up to 5 mm in depth. Importantly, this approach poses
no harm to facial fat tissue, addressing a common concern among
our patients. The Ultherapy system (Ultherapy; Ulthera Inc., MERZ,
AZ, USA) stands out as the sole MFU- V machine endorsed by the
US FDA for skin lifting, offering real- time imaging of structures to
be exposed to ultrasound energy delivery.1,2 This system seamlessly
integrates MFU with high- resolution ultrasound imaging (MFU- V),
allowing the visualization of tissue planes up to a depth of 8 mm.
Received: 8 Octob er 2023
|
Revised: 19 April 2024
|
Accepted: 3 May 2024
DOI: 10.1111/jocd.16374
ORIGINAL ARTICLE
New Ultherapy method: Utilizing novel surgical and anatomical
concepts yields outstanding results
Farahnaz Fatemi MD1 | Romina Najafian MD2 | Mohammad Amin Sadri MD2
This is an op en acces s article unde r the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium,
provide d the original wor k is properly cited.
© 2024 The Aut hor(s). Journal of Cosmetic Dermatology published by Wiley Periodica ls LLC.
1Dermatology, Department of
Dermatology, Skin Diseases and
Leishmaniasis Research Center, Isfahan
University of Me dical S ciences, Isfa han,
Iran
2School of Medicine, Isfahan Universit y of
Medical Sciences, Isfahan, I ran
Correspondence
Mohammad Amin Sadri, School of
Medicine, Isfahan University of Medical
Sciences, HezarJerib Avenue, Isfahan, Iran.
Email: sadri1377@gmail.com
Abstract
Background: Micro- focused ultrasound (MFU) is a technique for skin rejuvenation
and lifting, targeting the facial SMAS—a fibrous network encompassing the platysma
muscle and parotid fascia.
Objective: This study aims to propose a novel and cost- effective method (suggested
by Fatemi) for Ultherapy, comparing its effectiveness with the conventional approach.
Materials and Methods: A prospective double- blind clinical trial was conducted with
30 female volunteers randomly assigned to two groups: The control group (conven-
tional method) and the experimental group (new method). Ultherapy procedures uti-
lized MFU technology with low energy and a higher frequency.
Results: Statistically significant differences in lifting effects and improvement in skin
laxity were observed between the two groups. The new method, with a focus on the
parotideal area of the SMAS, demonstrated superior outcomes and higher patient
satisfaction.
Conclusion: The parotideal region's accessibility, increased thickness, and safety pro-
file make it an ideal target for Ultherapy. This not only reduces the risk of nerve injur y
but also yields effective collagen remodeling and skin- lifting results.
KEYWORDS
facial rejuvenation, noninvasive, skin laxity

|
2883
FATEMI et al.
Consequently, it empowers the user to pinpoint precisely where the
MFU energ y will be applied.
The focused ultrasound employed in this system c an elevate
the deep dermis and hypodermis to temperatures ranging from
60 to 70°C , an optimal range for collagen remodeling and neo-
collagenesis. Importantly, this heating effect is targeted, sparing
the epidermis and superficial dermis from any adverse impact. The
primar y advantage of MFU therapy lies in its profound penetration,
reaching a depth of 4.5 mm in the skin. This deep penetration results
in the creation of small spherical thermal coagulation points, each
with a diameter of less than 1 mm, within our target area—the SMAS.
Consequently, the energy reaches a depth of up to 5 mm from the
skin's surface.2 The facial SMAS assumes a pivotal role in surgical
facelif t procedures, with over 50% of facial rhytidectomies involving
some form of SMAS manipulation. When the SMAS is elevated supe-
riorly, it effectively lift s super ficial dermal and muscular structures,
notably improving sagging skin in the lower third of the face. Specific
facelif t techniques, such as the SPA facelift method, are described
with a focus on SMAS plication.3
Recent research indicates that the SMAS is not only thicker but
also horizonta lly aligned in the parotid region, sugges ting the poten-
tial for heightened lifting ef fects, par ticularly in the lower third of
the face. Aligned with this insight, our strategic approach involves a
deliberate emphasis on MFU shot s in this region. This targeted focus
aims to maximize the lifting effect while minimizing the overall num-
ber of shots required.1
By concentrating on the parotideal SMAS, we intend to optimize
the cost- effectiveness of MFU therapy. This focused strategy, sug-
gested by Fatemi, capitalizes on the thickness and accessibilit y of the
SMAS in this specific area, aligning with the latest understanding of
its anatomical characteristics.
2 | METHOD
In this prospective double- blind clinical trial, we recruited 30 volun-
teers who underwent a comprehensive explanation of the procedure,
including its limitations and potential side effects. Prior to inclusion
in the study, written consent forms were obtained from all partici-
pants, and the study protocol strictly adhered to the ethical guide-
lines outlined in the 1975 Declaration of Helsinki. Subsequently,
the volunteers were randomly assigned to two groups: the control
group, comprising 15 participants treated using the conventional
method, and the experimental group, consisting of 15 participants
treated with the new method. Both the patients and the research-
ers remained unaware of the treatment method employed, ensuring
blinding throughout the entire duration of the study.
The Ultherapy procedures were conduc ted by an expert der-
matologist who randomly assigned patients to each group. The
initial step involved marking the lower face and submental area, as
depicted in Figure 1, followed by scanning with the DS7- 3.0 trans-
ducer to precisely determine the distance of the SMAS from the skin
surface. Subsequently, the dermatologist selected the appropriate
transducer and shot counts for each patient, aligning with the tar-
geted treatment of the SMAS and, to a lesser extent, the dermis.
Total shot counts with each transducer used in both groups are pre-
sented in Table 2.
For all participants, the energy level was set to level 2, equivalent
to 0.30 J/cm2 for the 3 mm transducer and 0.90 J/cm2 for the 4.5 mm
transducer. In the control group, shots were administered in each
layer following the classic map depicted in Figure 1. In contrast, in
the experimental group, more than 50% of shots were specifically
delivered in the parotideal SMAS using either the DS 4- 4.5 or DS7-
3.0 transducer, as highlighted in the red quadrant of Figure 1.
FIGURE 1 Targeted treatment areas
where shots will be administered, and
shot number in the conventional method
using 4.5 mm transducer (A) and 3 mm
transducer (B).The red quadrant shows the
parotideal area where gives the majority
of shots in the new method.
Variable
Conventional method
(n = 15)
New method
(n = 15) Total (n = 30) p- value
Age (year) 51. 06 ± 7. 0 8 4 7. 6 0 ± 7. 6 4 49.3 ± 7. 4 4 0.208
BMI (kg /m2)24.26 ± 3.26 22.53 ± 1.64 23.43 ± 2.58 0 .77
TABLE 1 Baseline characteristics of
patients in the conventional and new
method groups.
Mean of shot counts Conventional method New method p- value
3 mm transducer 41 2. 00 ± 100.70 357. 8 6 ± 121.54 0.10 4
4.5 mm transducer 115.93 ± 122.95 130.00 ± 108.6 6 0.375
Tot a l 263.97 ± 185.85 243.9 3 ± 162 .08 0.437
TABLE 2 Mean shot counts in both
groups.

2884
|
FATEMI et al.
Photographs were captured for each patient before the pro-
cedure, immediately after ward, and again after 6 months using a
digital camera. To evaluate the improvement in sagging skin in the
middle and lower third of the face, the submental area, and the over-
all quality and laxity of facial skin, comprehensive questionnaires
were prepared. Two independent dermatologists, blinded to the
treatment groups, conducted a thorough evaluation of the before-
and- after photographs. They assigned scores ranging from 1 to 4 for
each participant, reflecting the degree of improvement observed.
Additionally, participants themselves completed identical question-
naires, of fering subjective scores for the enhancement in sagging
skin in specific areas and overall skin laxity.
3 | RESULTS
The study included a total of 30 female patients, evenly divided into
two subgroups: the conventional method group and the new meth od
group. The mean age and BMI of the participants were 49.3 ± 7.4 and
23.43 ± 2.58 respectively, with no significant differences observed
between the two groups in terms of age and BMI. Demographic
data, including age and BMI, are summarized in Table 1. Each sub-
group comprised 15 patients, as detailed in the table.
Table 2 displays the mean shot counts used in both groups. The
data indicates no significant difference between the total number of
shots and the counts for each transducer.
Table 3 illus trates the mean scores assigned by two dermatologists,
blinded to the groups, for each participant. Each participant received
four scores from each dermatologist, ranging from 1 to 4, assessing
the improvement in skin sagging in the middle and lower third of the
face, the submental area, and the overall enhancement in the qualit y
and laxity of facial skin. The results revealed a statistically significant
difference between the t wo groups across all four evaluated items.
Additionally, Table 4 presents the satisfaction level of the patients
in both groups. They scored from 1 to 4 for the same items as men-
tioned above. The results highlight that patients undergoing the new
method expressed a higher level of satisfaction with the procedure.
Figure 2 demonstrates the immediate lifting effect of the new
method af ter experiencing the procedure in a 59 year- old female.
Figure 3 shows a noticeable tightening of the lower third of the
face and even upper neck of a 54 year- old patient treated using the
new method After 6 months follow- up.
Figure 4 depicts the outcomes of the conventional method treat-
ment after 6 months. Due to the conventional approach targeting
the SMAS with fewer shots compared to the new method, the lif ting
effect is less pronounced. Additionally, linear erythematous lines are
visible in some treated areas immediately after the procedure. These
edematous pink streaks on the skin result from improper transducer
placement, a common and trivial side effect that typically subsides
after a few hours.
In addition to the assessments conduc ted immediately af ter
the procedures, we proactively reached out to all participants by
telephone. Importantly, none reported any complain regarding pa-
rotid gland such as pain, swelling, or xerostomia. As of now, nearly
1 year has passed since the procedures without any adverse events
reported.
4 | DISCUSSION
The primary focus of the Ultherapy procedure is the facial SMAS
(superficial musculoaponeurotic system). This fibrous network
encompasses the platysma muscle, parotid fascia, and the
Conventional
method
New
method p- value
Dermatologist 1 (mean score, range 1–4)
Middle part 2.26 3.06 <0.05
Lower part 2.46 3.60 <0.05
Submental 2.66 3.20 0.069
Overall improvement in skin quality and
laxity
2.73 3.33 <0.05
Dermatologist 2 (mean score, range 1–4)
Middle part 2.13 3.53 <0.05
Lower part 2.53 3.86 <0.05
Submental 2.00 3.46 <0.05
Overall improvement in skin quality and
laxity
2.40 3.80 <0.05
TABLE 3 Mean scores given by
dermatologists for the improvement of
skin sagging in dif ferent areas and the
overall enhancement in skin quality and
laxity.
TABLE 4 Mean scores given by participants for sagging skin in
different areas and overall skin laxit y improvement.
Conventional
method
New
method p- value
Middle part 1.53 2.66 <0.05
Lower part 2.13 2.86 <0.05
Submental 1.80 2.80 0.05
Overall facial skin
laxity
2.00 2.66 <0.05

|
2885
FATEMI et al.
fibromuscular layer covering the cheek. The fibromuscular layer
of the SMAS integrates with the superficial temporal fascia and
frontalis muscle superiorly and with the plat ysma muscle inferiorly.
The SMAS is often described as a fibrous degeneration of the
platysma muscle itself. However, the precise anatomical definition
of the SMAS remains unclear and has been a subject of debate since
its initial description in 1976 by Mitz and Peronei.4
In their 2010 study, Macchi et al. conducted an analysis of full-
thickness samples from the parotid, zygomatic, nasolabial fold, and
buccal regions in eight embalmed cadavers. The findings revealed
a progressive thinning of the SMA S, extending from the preauric-
ular district to the nasolabial fold.5 Sandulescu et al. shared their
experiences and findings regarding the morphological insights of the
midfacial SMAS through histological, SEM, and three- dimensional
analyses. Their study identified two distinct SMAS architectures: pa-
rotideal t ype IV and preparotideal type I SMAS. Within the parotid
region, the type IV SMAS extends between the parotid fascia and
the skin, characterized by fibrous septa aligned parallel to the skin.
Notably, no histologically recognized mimic muscles were observed
in this region. On the other hand, in the preparotideal region, the
type I SMAS exhibited a vertical alignment of fibrous septa connect-
ing the mimic muscles to the skin. This arrangement formed a fibro-
muscular meshwork of communicating compartments, supported by
fat tissue.6
FIGURE 3 A 54 year- old female who
underwent the new method. (A) Before
treatment, (B) 6 months after treatment.
Note also the marked improvement in skin
quality and tightening of the lower third of
the face and also the whole neck area.
FIGURE 4 A 63 year- old female who
underwent the conventional method. (A)
Immediately after treatment. (B) After
6 month follow- up.
FIGURE 2 A 59 year- old female
who underwent the new method. (A)
Before treatment, (B) immediately after
treatment. The marked area with white
pencil shows the area with the highest
concentration of shot s in this patient,
revealing an interesting and noticeable
effect on the entire jawline.

2886
|
FATEMI et al.
The Ultherapy procedure begins with the scanning of the skin in
the treatment area to visualize tissue planes for targeting the SMAS
throughout the procedure. In practice, our observation is that the
facial SMAS in the lower face is distinctly visible primarily in the pa-
rotid area, with altered visualization in the preparotid region. These
two aforementioned research studies elucidate that the clear visibil-
ity of the SMAS in the parotid area can be attributed to the fibrous
septa aligned parallel to the skin surface, situated just below the
subcutaneous fat.
As mentioned earlier, Ultherapy's key advant age lies in its ca-
pability to target the SMAS and lift the lower face. To effectively
achieve this objective, concentrating shots in the parotideal SMAS
is crucial. This contradicts current guidelines that do not empha-
size shots with 4.5 mm and only recommend a few shots with 3 mm
transducers in this critical area. In the parotid area, the SMAS is fully
visible parallel to the skin surface, rendering it entirely accessible to
focused ultrasound shots. Moreover, owing to its thickness in this
region, the SMAS, when contracting in response to created thermal
coagulation zones, induces significant traction, resulting in the lift-
ing of the skin and superficial muscles. A notewor thy point is that
some facial lift surgical procedures described in surgical references
involve only SMAS plication, such as the SPA facelift method.7
In one of these methods, axial lines along with two medial and
lateral parallel lines are drawn on the skin, extending from the lateral
canthus to the earlobe, indicating the prospective plication area. In
face- and neck- lifting procedures, these markings extend vertically
to the neck. Once the skin is undermined up to the marked lines, a
running lock suture is utilized for SMAS plication, incorporating large
superficial bites between the two distal lines. The author reports the
successful execution of 244 face- lift s using this technique, demon-
strating a notable absence of facial nerve problems and a high level
of patient satisfaction. Noteworthy in this face- lif t surger y method,
as described by Mottura et al., is the predominant focus on the pa-
rotideal SMAS—a critical area, as previously mentioned. This em-
phasis aligns with the objective of our ultherapy in the lower face.7
Fortunately, in the parotid area, there are no superficially significant
vessels, rendering it a considered safe zone according to surgical
references.
Another crucial consideration for us pertains to the presence of
superficial facial ner ves in this area. Rodulph et al. conducted de-
tailed measurements of facial nerve depth in 12 cadaver face halves
following bilateral face lift dissections in 1990. Their findings re-
vealed that the primary nerve trunk emerges anterior to the mid-
earlobe, reaching a depth of 20.1 ± 3.1 mm. The emergence of the
nerve from the parotid edge is also notable, with an average depth of
9.1 ± 2.8 mm for the temporal branch, 9.2 ± 2.2 mm for the zygomatic
branch, 9.6 ± 2.0 mm for the buccal branch, and 10.6 ± 2.7 mm for the
mandibular branches. According to their data, facial nerve branches
in areas such as postauricular, inferior to the zygomatic prominence,
and near the earlobe are either at significant depths or are absent.8
This safe area coincides with our target region in Ultherapy treat-
ment. During this procedure, MFU waves have the capability to
generate small thermal coagulation points (<1 mm) at a depth of up
to 5 mm within the skin. This characteristic renders the procedure
safe, minimizing the risk of causing nerve injury.
4.1 | Long- term safety
In addressing concerns about long- term safety, especially in the pa-
rotid area, there are concerns about damage to the parotid tissue.
Our Ultherapy method (Fatemi method) is designed to t arget the pa-
rotid region up to a maximum depth of 5 mm. Rigorous precautions,
including pre- procedural scanning of all patients, are implemented
to ensure precise targeting of shots to the SMAS while avoiding
deeper structures. Gelezhe et al. conducted a study using CT scans,
revealing that the mean depth of the parotid gland capsule from the
skin was 5.98 ± 2.2.9 Given our sc anner's capacity to inspect up to
9 mm, we can precisely identify the parotid gland's loc ation. This ca-
pability is crucial as it allows us to avoid inadvertent procedures on
parotid tissue. Moreover, studies investigating intense ultrasound
exposure on SMAS structures and ultrasound- guided percutane-
ous thermal ablation for benign parotid tumors have reported no
observable complications or damages beyond the superficial layers,
affirming the safety of such procedures. For example, in a study con-
ducted by Min Zhuang et al., benign parotid tumors were ablated
using ultrasound- guided percutaneous thermal ablation. To protect
surrounding normal parotid gland tissues and nerves, they injected
saline solution to create a separation zone of approximately 2 mm
thickness and ablated tumoral tissues using microwave with a power
of 30 W. They reported no serious complications with this method.10
Our study, employing a maximum shot energ y of 1.2 J on the skin po-
sitioned before the parotid capsule, further mitigates the likelihood
of causing any harm to the parotid tissue.
Another issue per tains to the rapid induction of protein coagu-
lation within the region of coagulation necrosis, leading to irrevers-
ible damage to crucial cytosolic and mitochondrial enz ymes, as well
as nucleic acid- histone complexes.11 This process can result in cell
death, denaturation, and the formation of scars. Furthermore, the
temperature required for optimal collagen shrinkage typically ranges
from 57 to 61°C, ensuring both safety and efficacy.12,13 However,
the treatment temperature employed in this method exceeds this
range, potentially leading to complete denaturation of collagen fi-
brils. To address these challenges, MFU therapy employs a targeted
approach, ensuring that the entire sur face of the SMAS is not uni-
formly affected by MFU waves. This technique closely resembles
fractional laser resurfacing, wherein small spherical thermal coag-
ulation points (with a diameter of less than 1 mm) are selectively
created within the SMAS, leaving normal tissues unaffected in be-
tween. Consequently, the risk of complications and scar formation
is significantly minimized. However, it is imperative to acknowledge
that further research is needed to comprehensively evaluate the
long- term safety implications of our method, particularly with re-
peated treatments over time.

|
2887
FATEMI et al.
5 | CONCLUSION
The new Ultherapy method presented in this article (Fatemi
method), designed based on surgical concepts and new pathological
and anatomical findings, is a safe and highly effective approach. It
has demonstrated remarkable results in skin lifting and skin quality
improvement with less time and cost from the patient, primarily due
to the limited number of shots.
FUNDING INFORMATION
There were no external funding sources for this research.
CONFLICT OF INTEREST STATEMENT
The authors declare no conflicts of interest related to this research.
DATA AVAIL ABI LIT Y STAT EME NT
The data that support the findings of this study are available on re-
quest from the corresponding author. The data are not publicly avail-
able due to privacy or ethical restrictions.
ETHICS STATEMENT
This study was conducted in accordance with the ethical guidelines
of the 1975 Declaration of Helsinki.
CONSENT
Written informed consent was obtained from the patients whose
photographs were used in this study. The consent forms for these
specific patient s are securely stored and are available upon request.
REFERENCES
1. Fabi SG. Noninvasive skin tightening: focus on new ultrasound
techniques. Clin Cosmet Investig Dermatol. 20 15 ;8 :47-52 .
2. Hitchcock TM, Dobke MK. Review of the safety profile for mi-
crofocused ultrasound with visualization. J Cosmet Dermatol.
2014;13(4):329-335.
3. Whitney ZB, Jain M, Jozsa F, Zito PM. Anatomy, skin , superficial m us-
culoaponeurotic system (SMAS) fascia. StatPearls; 2023 .
4. Broughton M, Fy fe GM. The superficial musculoaponeurotic s ys-
tem of the face: a model explored. Anat Res Int. 2013;2013:794682.
5. Macchi V, Tiengo C, Porzionato A, et al. Histotopographic study
of the fibroadipose connective cheek system. Cells Tissues Organs.
2010 ;191(1):47-56.
6. Sandulescu T, Buechner H, R auscher D, Naumova EA, A rnold WH.
Histological, SEM and three- dimensional analysis of the midfacial
SMAS–new morphological insight s. Ann Anat. 2019;222:70-78.
7. Mottura AA . SPA face lift: SMAS plic ation- anchoring. Aesth Plast
Surg. 2011 ;35( 4) :511-515 .
8. Rudolph R . Depth of the facial ner ve in face lift dissections. Plast
Reconstr Surg. 1990;85(4):537-544.
9. Gelezhe P, Frank K, Casabona G, et al. Safety considerations for
treating the parotid and submandibular glands with neuromodula-
tors for facial slimming. J Cosmet Dermatol. 2023;22(11):2957-2963.
10. Zhuang M, Lin Y, Wu S, et al. Ultr asound- guided percut aneous ther-
mal ablation of parotid tumors: experience from two- centers. Int J
Hyperth. 2024;41(1):2290924.
11. Ni Y, Mulier S, Miao Y, Michel L, Marchal G . A review of the
general aspects of radiofrequency ablation. Abdom Imaging.
2005;30:381-40 0.
12. Avram M, Hruza G. Lasers and Lights: Procedures in Cosmetic
Dermatology. Elsevier Health Sciences; 2013.
13. Shurrab K , Kochaji N, Bachir W. Development of temperature dis-
tribution and light propagation model in biological tissue irradiated
by 980 nm laser diode and using COMSOL simulation. J Lasers Med
Sci. 2017;8(3):118-122.
How to cite this article: Fatemi F, Najafian R, Sadri MA . New
Ultherapy method: Utilizing novel surgic al and anatomical
concepts yields outstanding results. J Cosmet Dermatol.
2024;23:2882-2887. doi:10.1111/jocd .16374