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628 GAZZETTA MEDICA ITALIANA - ARCHIVIO PER LE SCIENZE MEDICHE October 2023
ORIGINAL ARTICLE
Neck and face rejuvenation outcomes
with Profhilo®: a comparative analysis
between Chinese and Caucasian cohorts
Adele SPARAVIGNA 1 *, Clara CIGNI 2, Franco GRIMOLIZZI 2, Gilberto BELLIA 2
1Derming s.r.l., Clinical Research and Bioengineering Institute, Milan, Italy; 2IBSA Farmaceutici Italia s.r.l., Lodi,
Italy
*Corresponding author: Adele Sparavigna, Derming s.r.l., Clinical Research and Bioengineering Institute, via Valassina 29, Milan,
Italy. E-mail: adele.sparavigna@derming.com
ABSTRACT
BACKGROUND: Profhilo® is a well-known characterized formulation of thermally stabilized hybrid cooperative com-
plexes (HCC) that enables the delivery of high concentration (32 mg/mL) of low and high molecular weight hyaluronic
acid (HA) when injected in the skin dermis to treat skin laxity and reverse the signs of ageing. The aim of this study was
to compare the efcacy and safety outcomes of Profhilo® used for facial and neck rejuvenation in separate cohorts of
Chinese and Caucasian subjects by comparing the results of 3 clinical studies.
METHODS: For the face, main outcomes (Wrinkle Severity Rate Scale [WSRS] and Facial Volume Loss Scale [FVLS])
at TW4 and TW8 after Profhilo® treatment were compared. For the neck, IBSA Neck Skin Laxity Scale results at TW4
and TW8 between the two ethnicities were chosen to be examined.
RESULTS: The Chinese population showed overall better baseline scores. As to WSRS, at TW8 Chinese individuals
showed a reduction of 29%, compared to -12% in Caucasian ones. As to FVLS, the Chinese population had a decrease
of 48% compared to -21% in Caucasians. As to Neck Skin Laxity Clinical Score, the Chinese group diminished of 46%
compared to -21% recorded in the Caucasian ethnicity.
CONCLUSIONS: Treatment with Profhilo® showed to be benecial for neck and face rejuvenation in both populations
examined. However, Chinese subjects seemed to respond more rapidly and effectively than Caucasian ones. Genetic and
molecular differences of skin tissues in addition to muscle and bone anthropometric variations related to ethnicity may
result in a more favorable baseline and efcacy outcomes of Profhilo® treatment in Chinese patients.
(Cite this article as: Sparavigna A, Cigni C, Grimolizzi F, Bellia G. Neck and face rejuvenation outcomes with Profhilo®:
a comparative analysis between Chinese and Caucasian cohorts. Gazz Med Ital - Arch Sci Med 2023;182:628-33. DOI:
10.23736/S0393-3660.23.05199-9)
Key words: Neck; Face; Rejuvenation; Hyaluronic acid.
Gazzetta Medica Italiana - Archivio per le Scienze Mediche 2023 October;182(10):628-33
DOI: 10.23736/S0393-3660.23.05199-9
© 2023 EDIZIONI MINERVA MEDICA
Online version at https://www.minervamedica.it
Skin aging is due to intimate biological and
genetic mechanisms peculiar and unique for
each of us (i.e., intrinsic aging) combined to ex-
ternal factors (e.g., photoaging, cigarette smok-
ing, diet, work activity, psychophysical stress,
skin routine).1 In this context, an increasing de-
mand for aesthetic treatments and procedures
has raised over the last decades. In particular, the
main target of the aesthetic procedure is facial
treatment aimed to reduce wrinkles appearance
and skin laxity and to ameliorate skin quality and
texture.2-4
Although the request for aesthetic treatments
is currently spreading all over the world, sub-
stantial chronological differences are observed
among different ethnic groups in terms of ap-
pearance of skin aging signs (e.g., wrinkles,
folds, dyschromia, laxity). Overall Caucasian
populations have an earlier onset of ageing
with a more pronounced skin wrinkling than
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to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove,
cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.
NECK AND FACE REJUVENATION OUTCOMES WITH PROFHILO® SPARAVIGNA
Vol. 182 - No. 10 GAZZETTA MEDICA ITALIANA - ARCHIVIO PER LE SCIENZE MEDICHE 629
gy, mechanisms of aging, and cosmetic concerns
compared, which are pivotal information for any
specialists.10-12
Among rejuvenation treatments, hyaluronic
acid (HA) dermal llers have seen exponential
growth in recent years, due to the unique bio-
compatibility and safety characteristics of this
molecule.13 Interestingly, ethnic characteristics
drive patient demands and needs in this type of
aesthetic treatment as well. Caucasians undergo
ller treatment mainly to correct wrinkles and
other facial changes caused by ageing.14 In con-
trast, Asian people undergo cosmetic procedures
at a relatively younger age and receive llers for
volume correction for inborn features such as
at noses, depressed foreheads and midfacial ar-
eas, and small chins; nevertheless, middle-aged
and older Asian individuals also demand ller
treatment for wrinkles or facial sagging elimina-
tion.5-7
The purpose of this paper is to compare the
different outcomes of Profhilo®, a well charac-
terized formulation of low and high molecular
weight HA, in terms of efcacy and safety in
facial and neck rejuvenation in similar cohorts
of Chinese and Caucasian subjects in terms of
medical history and demographic characteristics
by comparing the results of 3 previously pub-
lished clinical studies, with the aim of evaluating
the results of this product in subjects with differ-
ent ethnic characteristics to possibly optimize its
use.15-17 Secondary objective is to set a precedent
that will stimulate future interethnic comparisons
of the clinical outcomes of this device involving
other parts of the body.
Materials and methods
The papers used to carry out the comparative
analysis are briey outlined in their main meth-
ods and results. Comparisons between the two
groups were performed evaluating WSRS and
FVLS at baseline visit (T0) and 4 and 8 weeks
after the beginning of the treatment (T4W and
T8W, respectively) for face analysis. Neck results
were compared using IBSA Neck Skin laxity18
scale evaluated at T0, T4W and T8W for both
groups. The outcomes obtained by the different
studies were further elaborated and evaluated
Asians, in whom the combination of increased
supercial fat and thickened dermis decreases
the occurring of supercial rhytides.5 Evidence
shows that the Asian face retains its youth-
ful appearance for longer, compared with age-
matched Caucasians.6, 7 The facial structure of
Asian subjects comprise round face, a retruded
chin, higher eyebrows, fuller upper lids, pro-
tuberant lips, a atter malar prominence and
midface, and a lower nasal bridge with hori-
zontally placed ared ala.8 In the Asian popula-
tion, for instance, wrinkle development shows
a biphasic trend, with a slow increase until the
4th and 5th decade, followed by a fast worsening
afterwards.6 Anatomical differences in skeletal
structural support delays aging in Asians.5, 6
The dense fat and brous connections between
the supercial muscular aponeurotic system
(SMAS) and deep fascia which characterize
people of Asian ethnicity delay midfacial sag-
ging. Therefore, Asian people can preserve
their youthful appearance for a longer time than
Caucasian people. However, despite the initial-
ly thicker skin, the loss of dermal support, the
heavier malar fat pad and weaker skeletal sup-
port in the Asian face eventually cause tissue
descent.7 Caucasian faces generally have more
pronounced three-dimensionality with larger
eyes, a greater anterior projection of the brows,
nose, maxilla, chin, along with a narrower and
greater vertical height.9
A growing body of literature in this area re-
veals how this disparity is being investigated
especially in the eld of aesthetic medicine, as
rejuvenation interventions need to be tailored
to the unique characteristics of each patient and
one’s unique way of aging. An accurate history
of the subject and their clinical setting in order
to establish the most appropriate aesthetic treat-
ment plan must necessarily take into account
phototype, musculature and soft tissues as a
whole, and bone structure, which are elements
that are also inherently inuenced by belong-
ing to a particular ethnic group.10 Consequently,
when performing any facial rejuvenation proce-
dures, aesthetic physicians should take into ac-
count anatomical, biological, and anthropomet-
ric characteristics depending on patients’ ethnic-
ity, which lead to different skin pathophysiolo-
COPYRIGHT
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This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one le and print only one copy of this Article. It is not permitted to make additional copies (either sporadically
or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet le sharing systems, electronic mailing or any other means which may allow access
to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove,
cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.
SPARAVIGNA NECK AND FACE REJUVENATION OUTCOMES WITH PROFHILO®
630 GAZZETTA MEDICA ITALIANA - ARCHIVIO PER LE SCIENZE MEDICHE October 2023
-12% vs. T0, at T4W and T8W respectively). Al-
though the baseline situation for FVLS is more
similar between the two groups, a similar trend
has been found for this scale. Chinese population
showed indeed a better improvement for FVLS
already at T4W (-35% vs. T0) compared to the
result obtained by Caucasian population (-6% vs.
T0 at T4W). Moreover, the difference was also
maintained when evaluations was performed at
longer timepoints: Chinese group still showed a
better improvement (-48% vs. T0) compared to
the Caucasian one (-21% vs. T0) at T8W.
Neck
IBSA Neck Skin Laxity scale has been chosen
to compare the studies outcomes for the neck
(Figure 2). As for face analysis, Chinese popula-
tion presented better baseline scores and a bet-
ter improvement trend after treatment compared
as percentages of improvement versus baseline
visit (T0) in order to normalize the results and
performed the comparison. Table I summarizes
studies’ main information (ethnic group, meth-
odology and main outcomes).15-17
Comparative analysis results
Face
Face analysis evaluations compared the WSRS
and FVLS obtained results between the two
groups at T4W and T8W after beginning of the
treatment (Figure 1).
Subjects of Chinese ethnicity started from a
more favorable situation at baseline than Cau-
casian ones. Furthermore, Chinese population
showed a better and faster improvement of WSRS
both at T4W (-22% vs. T0) and T8W (-29% vs.
T0) compared to Caucasian population (-6% and
Table I.— Main outcomes of studies selected for comparative analysis.15-17
Ethnic group Caucasian – Italian
64 women
38-60 years old
Caucasian – Italian
23 women
40-65 years old
Asiatic – Chinese
28 women
30-60 years old
Treatment area and
protocol used
• Face
• BAP technique
• 2 injections (30 days apart)
• Follow up at 4, 8, 12 and 16
weeks
• Neck
• BAP technique
• 2 injections (30 days apart)
• Follow up at 4 and 16 weeks
• Face and neck
• BAP technique
• 2 injections (30 days apart)
• Follow up at 4, 8 weeks
Main clinical
outcomes
• Clinical improvement already
signicant at T4W and T8W.
• Improvement was maintained at
longer timepoints.
• Tolerability was evaluated as
excellent or good
• Clinical improvement already
signicant at T4W.
• Improvement was maintained
at T16W.
• Tolerability was evaluated as
excellent or good
• Clinical improvement already
signicant at T4W.
• Improvement was maintained
at T8W.
• Tolerability was evaluated as
excellent or good
Publication Sparavigna et al.15 Sparavigna et al.16 Sparavigna et al.17
Figure 1.—WSRS (A) and FVLS (B) evaluated for Caucasian and Chinese populations at baseline, 4 and 8 weeks after treat-
ment (T0, T4W and T8W respectively). Percentages were calculated as fold decrease vs. T0.
A B
WSRS scale
3,5
3,3
3,1
2,9
2,7
2,5
2,3
2,1
1,9
1,7
1,5 T0 T4W T8W
Chinese Caucasian
FVLS scale
3,5
3,3
3,1
2,9
2,7
2,5
2,3
2,1
1,9
1,7
1,5 T0 T4W T8W
Chinese Caucasian
-6%
-12%
-22%
-29%
-6%
-21%
-48%
-35%
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2023 EDIZIONI MINERVA MEDICA
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or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet le sharing systems, electronic mailing or any other means which may allow access
to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove,
cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.
NECK AND FACE REJUVENATION OUTCOMES WITH PROFHILO® SPARAVIGNA
Vol. 182 - No. 10 GAZZETTA MEDICA ITALIANA - ARCHIVIO PER LE SCIENZE MEDICHE 631
less cohesive stratum corneum with increasing
age, with reduced skin extensibility and disorga-
nized elastic bers in the dermis.19 Pigmentary
alterations such as lentigines and seborrheic ker-
atosis are common among Asians, even though
wrinkles tend to manifest 1-2 decades later than
in age-matched Caucasians.20 A study comparing
age-matched Asian women to Caucasian-French
ones with similar lifelong sun exposure revealed
that although wrinkle onset was delayed by 10
years, pigmented spot intensity was more preva-
lent in Asian subjects as compared to French
Caucasians.21
From a strictly clinical point of view, in the
lower face Caucasian subjects show during ag-
ing process ne perioral and periorbital rhytides,
decreased lip volume and perioral lip lines, and
jowling of the neck with effacement of cervico-
mental angle; on the upper face, ne and deep
rhytides appear in the forehead and glabella;
as to midfacial region, laxity of the upper and
lower eyelids, pseudoherniation of orbital fat
pads, increased redundancy of soft tissue, and
descent of the melolabial fat pad toward the na-
solabial fold take place.22, 23 Moreover, bone re-
modeling of the superomedial and inferolateral
orbital rims contributes to brow ptosis, crow’s
feet, lower lid lag, resulting in dermatochalasis
of the upper lid, lengthening of the lower lid,
prominence of the nasolabial folds, and a double
convexity of the midface.8 Extrinsic photoaging
secondary to UV radiation leads to premature
coarse and ne wrinkling, textural roughness,
telangiectasia, mottled pigmentation, and sal-
lowness.24
Beside skin intrinsic structure, several envi-
ronmental factors contribute to the delayed skin
aging observed in Asians, such as a diet which is
rich in antioxidants (e.g., green tea and omega-3
and -6 fatty acids), lower smoking rates, and the
use of higher SPF.25, 26 Moreover, sociocultural
aspects such as the less use of mimic muscles
and facial expressions which involve the upper
face and the forehead when communicating, may
also play a role in the less pronounced develop-
ment of dynamic wrinkles in Asians.27
These different microscopic and macroscop-
ic features of ageing that inuence the timing
and pattern of appearance of signs of skin se-
to Caucasian population. The obtained results
showed a clear and major improvement in the
Chinese group (-33% vs. T0) compared to the
Caucasian group (-15% vs. T0) already at T4W.
The better improvement trend was also con-
rmed at TW8: -46% vs. T0 for the Chinese pop-
ulation and -21% vs. T0 for the Caucasian one.
Overall, there is a benet of treatment in
both populations, which is, however, more pro-
nounced in the Chinese population that seems to
respond more rapidly.
Discussion
Several studies discuss the ndings concerning
ethnic variation in skin pigmentation and signs
of ageing highlighting implications for cosmetic
science. A study by Lin et al. analyzed Cauca-
sian and Asian skin different intrinsic ageing,
found that the dermal papilla (DP) volume per
unit area and depth in Caucasians decreased at a
faster rate than in Asians, who showed a higher
content of water, melanin, collagen, and dermal
thickness which remain constant over time, and
this might be a primary factor of the different
skin aging outlook between these two ethnic
groups.1 Moreover, as observed by Vashi et al.,
Caucasian subjects present a lightly pigmented
skin with small, aggregated melanosomes along
with decrease amounts of melanin which predis-
poses these individuals to develop earlier signs
of photoaging than other populations.8 More-
over, the Caucasian skin shows a thinner and a
Figure 2.—IBSA Neck skin laxity and roughness clinical
score evaluated for Caucasian and Chinese populations at
baseline, 4 and 8 weeks after treatment (T0, T4W and T8W
respectively). Percentages were calculated as fold decrease
vs. T0.
IBSA neck skin laxity scale
3,5
3
2,5
2
1,5
1
T0 T4W T8W
Chinese
Caucasian
-15%
-21%
-33%
-46%
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2023 EDIZIONI MINERVA MEDICA
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one le and print only one copy of this Article. It is not permitted to make additional copies (either sporadically
or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet le sharing systems, electronic mailing or any other means which may allow access
to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove,
cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.
SPARAVIGNA NECK AND FACE REJUVENATION OUTCOMES WITH PROFHILO®
632 GAZZETTA MEDICA ITALIANA - ARCHIVIO PER LE SCIENZE MEDICHE October 2023
Conclusions
Growing evidence demonstrates the efcacy and
safety of Profhilo® for rejuvenation of various
anatomical parts. The present comparative anal-
ysis assessed face and neck outcomes in Cauca-
sian and Chinese subjects’ cohorts. Chinese pa-
tients have demonstrated to respond better and
earlier to the treatment compared to Caucasian
population. Nevertheless, the overall satisfaction
of both populations involved in the studies and
the specialists who performed the procedures
conrms that Profhilo® is able to respond to dif-
ferent needs by achieving the goal of restoring
lost freshness and volume.
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S, Swift A, et al.; Global Aesthetics Consensus Group. Global
aesthetics consensus: hyaluronic acid llers and botulinum
toxin type A-recommendations for combined treatment and
nescence result in different needs. Practitioners
commonly proposed HA in young Asians to re-
shape and recontour facial features, to address
structural deciency of midline facial features,
while correcting atness of the infraorbital and
medial malar regions, reducing under-eye shad-
ows, improving projection and denition of the
nose and chin.28-31 For older Asian subjects, HA
llers are mainly used to restore volume loss in
areas of intrinsic anatomical structural decien-
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The subjects enrolled in the studies evaluated
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Whereas the results in terms of treatment safety
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better baseline clinical situation of the subjects
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outcome.
Limitations of the study
One limitation of this comparative analysis is
related to the short timepoint evaluated. This
was unfortunately due to the shorter follow-up
performed in the study evaluating the Chinese
population and resulting from the pandemic situ-
ation that prevented longer follow-up for this
study.17 Further studies and comparative analy-
sis are needed to better evaluate the product
performance at longer timepoints among differ-
ent ethnicities. Despite this limitation, Profhilo®
treatment showed promising results for Chinese
population. Taken together and considering sci-
entic literature on Asiatic population, results
lead to hypothesize that the better-preserved cel-
lularity and tissue integrity of Chinese subjects
may have promoted a better take-up of Profhilo®
treatment. This different efcacy of the device
depending on ethnic characteristics could have
interesting implications regarding the adminis-
tration timepoints and protocol of the product for
this ethnicity.
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2023 EDIZIONI MINERVA MEDICA
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one le and print only one copy of this Article. It is not permitted to make additional copies (either sporadically
or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet le sharing systems, electronic mailing or any other means which may allow access
to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove,
cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.
NECK AND FACE REJUVENATION OUTCOMES WITH PROFHILO® SPARAVIGNA
Vol. 182 - No. 10 GAZZETTA MEDICA ITALIANA - ARCHIVIO PER LE SCIENZE MEDICHE 633
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Conicts of interest
Adele Sparavigna declares no conict of interest; Clara Cigni, Franco Grimolizzi and Gilberto Bellia are employees of IBSA Farma-
ceutici Srl.
Funding
Medical writing has been supported by the IBSA Farmaceutici Italia Srl. This study has been sponsored by the IBSA Farmaceutici
Italia Srl.
Authors’ contributions
All authors read and approved the nal version of the manuscript.
Acknowledgements
The authors are grateful to Marta Castano for helping in writing the manuscript.
History
Manuscript accepted: July 26, 2023. – Manuscript received: July 18, 2023.
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