Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 271-280
Published Online December 2013 (http://www.scirp.org/journal/jcdsa)
http://dx.doi.org/10.4236/jcdsa.2013.34041
Open Access JCDSA
271
An Innovative Concept Gel to Prevent Skin Aging
Adele Sparavigna1, Beatrice Tenconi1, Ileana Deponti1, Francesco Scarci2, Maurizio Caserini2,
Federico Mailland2
1Derming, Clinical Research and Bioengineering Institute, Monza, Italy; 2Scientific Department, Polichem S. A., Lugano, Switzer-
land.
Received November 15th, 2013; revised December 6th, 2013; accepted December 12th, 2013
Copyright © 2013 Adele Sparavigna et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
The study aimed to evaluate the instrumental and clinical properties of an innovative gel formulation for anti-aging
treatment. This was an open, non-controlled study, where the eligible subjects, divided into three subgroups according
to age, had to perform a single dose application of the gel on the face for a short-term evaluation and a 4-week repeated
use, twice a day, for a long-term evaluation. Instrumental and clinical evaluations had to be performed mono-laterally at
the level of the face (right or left side according to a predisposed randomization list) in basal conditions (T0), 20 minutes
after the first dose application (T20min) and after 2 and 4 weeks of treatment (T2wks - T4wks). Thirty-three subjects com-
pleted the study showing, after only 20 minutes from the 1st product application, a clinically important and statistically
significant improvement of crow’s feet, skin dullness clinical score and cutaneous microrelief clinical score (p < 0.05),
after 2 weeks of treatment, an improvement of skin tonicity (p < 0.05) and after 4 weeks of treatment having a signifi-
cant decrease of nasolabial folds clinical score (p < 0.05). The study showed the great efficacy of an innovative anti-
aging gel in reducing the skin roughness and skin dryness, improving the skin firmness and, in general, providing a
global skin rejuvenation.
Keywords: Skin; Wrinkles; Anti-Aging
1. Introduction
The demand for an anti-aging therapy is increasing day
by day and it is not only a prerogative of women as a
personal vanity issue; the request is also strong in men,
often linked to professional needs. In fact, actors, corpo-
rate executives, politicians and showmen (showgirls)
need to appear younger and more beautiful. In general,
people want to appear younger because a youthful ap-
pearance can result in better mental and physical health.
The main problem is therefore focused on how to guar-
antee such expectations as ageing is an unavoidable and
irreversible physiological process that leads to some
changes in the body [1]. The structure of the skin is made
primarily of two layers. The outer layer is the epidermis,
made mainly of keratinocytes responsible for the forma-
tion of a barrier against environmental damage; the inner
one, the dermis constitutes connective tissue and struc-
tural components such as collagen (responsible for the
skin firmness), elastic fibers (responsible for the skin ela-
sticity) and extracellular matrix (structural component).
The appearance of the skin reflects general health and
communicates ethnicity, lifestyle and age. These features
are largely determined by skin color, texture, firmness,
and smoothness. Aging has a large impact on the quality
of all these features [2]. The skin is exposed every day to
the environment, oxidative stress and inflammation and
for this reason, it undergoes alterations of its structure,
leading to the appearance of wrinkles.
Clinically, aged skin may be thin, smooth and with
only light wrinkles, but it can also appear thicker with
deeply marked wrinkles and with irregular pigmentation
[3,4]. Skin ageing is characterized by an alteration of
structural components of the connective tissue with the
consequent formation of skin wrinkles consisting of a
disorganization or damage of these skin structures due to
a lack of collagen or to its modification, thinning and/or
fractioning, caused by the stretching and repeated exten-
sion of some areas of the skin, especially the face [5].
The lack of elastin, for example, has an important role
in the formation of wrinkles, due to the loss of elasticity
[6].

An Innovative Concept Gel to Prevent Skin Aging 272
A wrinkle is a fold, a ridge or crease in the skin, which
appears as a result of the ageing processes such as glyca-
tion [7], or promoted by habitual facial expressions, skin
type, photo-aging, solar UV irradiation, the effect of
gravity, tobacco smoke, hormonal status, pollution, mal-
nutrition, poor hydration and genetic factors [8,9].
There are a lot of treatments boasting the capability to
improve wrinkles: pharmaceutical, surgical and cosmetic
solutions. These treatments are intended to change the
nature of ageing collagen, stretch the skin, fill in the de-
pressions of the skin or paralyse the muscles that cause
the wrinkle. Retinoid products, for example, act by in-
hibiting enzymes from breaking down collagen, but they
may produce redness, burning and general discomfort
[10]; alpha-hydroxy acids penetrate into the top layer of
the skin, producing only subtle improvement, though,
and causing a mild and temporary irritation, increasing
the skin’s sensitivity to the sun and particularly increas-
ing the possibility of sunburn [11]; the anti-aging Serum
stimulates the skin to rebuild the collagen and elastin
network in the dermis resulting in a renewal of skin
structure, improving the skin elasticity and smoothing the
wrinkles. The disadvantages, however, are related to the
cost and the fact that very often the real composition of
these compounds, obtained from an animal source, is not
specified. Moreover, reproducibility may not be guaran-
teed and animal extracts may pose safety issues. In the
surgical field, there are several techniques that could re-
sult in an excellent improvement but that also produce
significant side effects, including scarring and permanent
changes in skin color. In other cases, the improvements
may last some months then surgery must be repeated.
Again, surgical procedures are the opposite to the tissue
regeneration process, acting only in an aesthetic way but
not in the sense of skin rejuvenation. Cosmetic products
include superficial or deeper peels that act in smoothing
fine lines and scarring. However, their action is opposite
to the tissue regeneration, mostly by trying to improve
the skin depressions by lifting the uppermost skin layer.
Antioxidants, on the other hand, provide protection from
the sun, neutralizing the free radicals responsible for the
collagen breakdown: by this mechanism, antioxidants
may be very important in the prevention of the further
worsening of wrinkle forming. Finally, moisturizers can
make wrinkles look temporarily less prominent, keeping
the skin hydrated.
As a conclusion, the best product to treat and prevent
wrinkle formation should act by regenerating tissues
(mostly collagen), by opposing oxidation and by mois-
turizing skin. In view of all these considerations, a screen-
ing was made among different formulations to identify
the best possible product for treatment and prevention of
wrinkles. That product, P-3086, contains as main ingre-
dient hyaluronic acid, hops and ethanol. P-3086 has been
tested in the present study in order to evaluate its instru-
mental and clinical properties.
2. Materials and Methods
The clinical trial was performed in accordance with the
GCP-ICH guidelines. The protocol was approved by an
independent Ethics Committee. Each subject recruited
for the study, signed an informed consent form, after
having been fully informed.
2.1. Subjects and Study Design
This was an open study aimed to enroll 33 healthy fe-
male volunteers, aged 35 - 65 years, stratified in three
different groups of 11 women each: 35 - 44 years (Group
1), 45 - 54 years (Group 2) and 55 - 65 years (Group 3).
All of them had to present light-moderate facial rhytido-
sis, without any concomitant disease on the tested area.
Each qualifying subject, who met the inclusion/exclu-
sion criteria, performed a single fixed application of the
gel on the face (including the submental area) for a short
term evaluation and for 4 weeks of repeated use, twice a
day (long term evaluation), in the morning and in the
evening, with a mild massage.
Instrumental and clinical evaluations were performed,
mono-laterally at level of the face (right or left side ac-
cording to a predisposed randomization list), in basal
conditions (T0), 20 minutes after the first product appli-
cation (T20min) and after 2 and 4 weeks of treatment (T2wks
- T4wks).
2.2. Instrumental Assessment
Instrumental measurements were performed in standard-
ized conditions mono-laterally on the face (right or left
facial side, randomly) in basal conditions (T0), 20 min-
utes after the first product application (T20min) and after 2
and 4 weeks of treatment (T2wks - T4wks), by means of
non-invasive instruments.
The Corneometer CM825 (Courage–Khazaka, Köln,
Germany) was used to measure the skin electrical ca-
pacitance that is an index of the skin hydration. In order
to reduce the variability of the measurement method, for
each volunteer, three measures on the same skin area
were performed: the adjusted mean was intended as the
real measure value.
In order to measure the skin elasticity grade, the Tor-
siometry was considered as the most effective way, as it
is very sensitive to variations of the mechanical proper-
ties of the stratum corneum. Skin firmness was therefore
measured with the Dermal Torque Meter (Dia-Stron Ltd.,
UK). This instrument is based on the principle of torsion,
given to the skin surface by a probe made of two circles
that adhere to the skin through shaped adhesive tapes.
While the external circle is still, the internal circle rota-
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An Innovative Concept Gel to Prevent Skin Aging 273
tion exerts a constant torsion of skin (torsion time = 1
second with a torque = 9 mN*m). The instrument meas-
ures the torsion angle (θ) during the mechanical stimulus
(“torque on”) and after it has ceased (“torque off”).
For each of the considered curves (“torque on” and
“torque off”) the cutaneous rotational ratio relative to
define measured times can be measured, obtaining the
parameters listed below:
Ue: immediate extensibility (“torque on” at 0.02 sec.)
Uf: maximum extensibility (“torque on” at 0.9 sec.)
Uv: viscoelasticity
Ur: immediate elastic recovery (“torque off” at 0.02
sec.).
Among methods studied to measure skin elasticity,
torsion is demonstrated to be one of the most effective; in
fact this method proved to be very sensitive to variation
of skin mechanical properties.
The crow’s feet area was quantitatively assessed using
Primos compact portable device (GFMesstechnik GmbH,
Berlin, Germany). The Primos software elaborates 3D
representations of skin wrinkles as well as measuring
skin principal profilometric parameters in vivo or on skin
replicas, according to DIN EN ISO 4228, using a digital
stripe projection based on micro mirrors which allow a
fast and highly precise measurement data acquisition.
Moreover the software compares directly the different
images obtained at the different time points as foreseen
by the protocol (T0, T20min, T2wks and T4wks).
In order to determine the activity of the tested formu-
lation on skin complexion and on skin brightness, the
spectrophotometric and colorimetric measurements were
performed mono-laterally at the cheekbone level. Skin
color was measured by a visible-UV-IR (λ from 300 to
900 nm) spectrophotometer (Spectrophotometer DH2000
Top Sensor System) which uses a tungsten halogen lamp
and a deuterium lamp, according to CIE (Commission
Internationale de l’Eclarage), the main international or-
ganization concerned with color and color measurement.
Lamps are switched on 30 minutes before instrument use
in order to achieve a stable emission. Measurement angle
is 90˚ (position of the probe on the skin) and measured
area is 2 mm2; the used wavelength range of 380 - 780
nm corresponds to the visible light spectrum.
The measurement of the skin brightness was per-
formed by a tri-stimulus colorimeter (Chroma Meter CR-
200®-Minolta), equipped with three special filters to ob-
tain R,G,B values according to CIE. L*a*b* system
(CIELAB), the most complete colour-space specified by
the CIE (1976), describes all the colours visible to the
human eye. The three coordinates of L*a*b* represent
the lightness of the colour (L* = 0 yields black and L* =
100 indicates diffuse white), its position between red/
magenta and green (a*, negative values indicate green
while positive values indicate magenta) and its position
between yellow and blue (b*, negative values indicate
blue and positive values indicate yellow).
Face ptosis determination was carried out by photo-
graphic techniques and image analysis; a frontal facial
picture of each volunteer was taken at all different time
points. In order to ensure comparable images, the pic-
tures were taken using a standardized method, to measure
the facial coordinates of each subject in order to identify
the relaxed cutaneous area. Image elaboration for face
coordinates evaluation was conducted by computer im-
age analysis.
2.3. Clinical Assessment
In order to determine the wrinkles grade at level of the
nasolabial folds and of the lateral corner of the eye
(“crow’s feet”), a reference clinical scale was used:
0 = No wrinkles, 1 = Very weak wrinkles, 2 = Weak
wrinkles, 3 = Quite evident wrinkles, 4 = Evident wrin-
kles, 5 = Very evident wrinkles, 6 = Marked wrinkles, 7
= Very marked wrinkles.
Submental ptosis was scored from 0 (absence of ptosis
–very regular oval face) to 5 (very marked ptosis–very
irregular oval face) according to a clinical photographic
scale.
Based on a photographic scale for the cheek, surface
microrelief was evaluated according to following score:
1 = very regular: the primary lines present all the same
depth. The secondary lines are well demarcated and form
star like picture (apexes converge of several triangles).
2 = regular: hiding and loss of secondary lines de-
marcation. Star-like pictures are still present but with less
demarcated secondary lines.
3 = irregular: primary lines irregularity. Strong hiding
of lines with low presence of star-like pictures.
4 = very irregular: strong deterioration in the skin.
Deep primary lines distortion and loss of secondary lines.
Skin dullness of the overall face was evaluated ac-
cording to the following score:
1 = luminous skin, 2 = normal skin, 3 = opaque skin, 4
= very opaque skin.
Skin resistance to pinching, resistance to traction and
recovery after pinching, were performed at level of cheek
(malar region) according to the following score:
0 = very important, 1 = important, 2 = moderate, 3 =
weak, 4 = very weak.
Skin dryness was evaluated at cheek level (malar re-
gion) according to the following score:
0 = very hydrated skin, 1 = hydrated skin, 2 = normal
skin, 3 = slightly dry skin, 4 = dry skin, 5 = very dry
skin.
In order to determine the anti-age effect of the study
product, the data (mean value) of all considered clinical
parameters were combined by means of a particular
graph named SpidermingTM, which represents an innova-
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An Innovative Concept Gel to Prevent Skin Aging 274
tive and validated method for the description and the
visualization of the skin aging grade before and after
cosmetic treatments [12]. SpidermingTM allows visuali-
zation of the anti-age effect of a cosmetic product, also in
function of the age range and the sex of the included
subjects.
2.4. Statistical Analysis
The activity of the product at T20min, T2wks and T4wks was
expressed in absolute values versus baseline (T0) for the
entire population and for each one of the evaluated
groups (35 - 44 years, 45 - 54 years, 55 - 65 years).
- Instrumental evaluations were processed by analysis
on variance (ANOVA) to test the differences between
group means, followed by, in presence of statistically
significant results, Dunnett’s test used in a multiple
comparison procedure aimed at comparing each of a
number of treatments with a single control, for clinical
evaluations.
- Clinical Evaluations were processed by Friedmann
test: a non-parametric statistical test, used to detect dif-
ferences in treatments across multiple test attempts fol-
lowed by, in presence of statistically significant results,
Dunnett’s test.
A comparison between groups was carried out at each
considered time as follows:
- ANOVA followed by, in presence of statistically sig-
nificant results, Tukey test, for instrumental evaluations;
it compares the means of every treatment to the means of
every other treatment.
- Friedmann test followed by, in presence of statisti-
cally significant results, Tukey test, for clinical evalua-
tions.
A difference was considered to be statistically signifi-
cant at p < 0.05.
3. Results
All thirty-three subjects enrolled (11 subjects for each
study group) completed the study. With regards to the
Instrument evaluation and in particular the anti-wrinkle
efficacy (“crow’s feet” profilometry), the obtained results
for the entire population and per separated age groups are
summarized in Table 1.
The statistically significant reduction (Dunnett’s test p
< 0.05 T2wks/T4wks vs. T0) of Rt parameter (total height of
the wrinkle) and the clinically important reduction of Ra
(average roughness of the wrinkle) and Rv (maximum
depth of the wrinkle) underlined the important anti-
wrinkle activity of the study product. Analyzing the three
different study groups, it is evident that, particularly on
Group 1, but also on Group 2, the anti-wrinkles activity
results were very high, significantly superior in Group 1
compared to Group 3 (Ra: Dunnett’s test p < 0.05 T2wks
Table 1. Anti-wrinkle efficacy variation vs. baseline on uni-
fied data and on separated groups pe r e a c h parameter.
Variation vs. Baseline (%)
T20 min T2 wks T4 wks
Ra (average roughness)−10% −14.7% −16.5%
Rt (total height) −12.5% −21% (*) −23.8% (*)
Rv (maximum depth) −14.8% −13.8% −20.4%
(*) = Dunnett test p < 0.05
Variation vs. Baseline (%)
Ra (average roughness)
T20 min T2 wks T4 wks
Group 1 (35 - 44) −16.5% −23.6% (*#) −33% (*#)
Group 2 (45 - 54) −19.2% −21.3% (*) −26.3% (*)
Group 3 (55 - 65) 3.6% −1.6% 5.1%
(*) = Dunnett test p < 0.05 (#) = Tukey test p < 0.05 vs. Group 3
Variation vs. Baseline (%)
Rt (total height)
T20 min T2 wks T4 wks
Group 1 (35 - 44) −19.2% −23.7% −34% (*)
Group 2 (45 - 54) −20.7% −24.5% −25.2%
Group 3 (55 - 65) 2.2% −14.7% −12.5%
(*) = Dunnett test p < 0.05
Variation vs. Baseline (%)
Rv (maximum depth)
T20 min T2 wks T4 wks
Group 1 (35 - 44) −21.3% −20.5% −28.8%
Group 2 (45 - 54) −24.2% −18.9% −28.4%
Group 3 (55 - 65) −0.4% −2.9% −5.3%
and T4wks vs. T0 for both groups and Rt: Dunnett test p <
0.05 T4wks vs. T0 for Group 1. Ra: Tukey test p < 0.05
T2wks and T4wks Group 1 vs. T2wks and T4wks Group 3).
With regards to the skin electrical capacitance (hydra-
tion), a statistically significant increase was achieved al-
ready after the first product application (Dunnett’s test
p < 0.05 T20min vs. T0), with an improvement of 13.9% vs.
T0; after 2 and 4 weeks of treatment this result remained
statistically significant (+11.1% at T2wks and +12.9% at
T4wks; Dunnett test p < 0.05 vs. T0), confirming the
substantive moisturizing activity of the tested product
(Figure 1) mostly in Group 2 (Dunnett’s test p < 0.05
T20min, T2wks and T4wks vs. T0 for Group 2) (Table 2).
Data of considered torsiometric parameters of the en-
tire study population are summarized in Table 3 : a clini-
cally important and statistically significant reduction
(Dunnett’s test p < 0.05 vs. T0) of all torsiometric pa-
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An Innovative Concept Gel to Prevent Skin Aging 275
Table 2. Skin electrical capacitance variation for separated
groups.
Hydration Variation vs. Baseline (%)
T20 min T2 wks T4 wks
Group 1 (35 - 44) 9.9% 2.4% 4.2%
Group 2 (45 - 54) 18.5% (*) 22.6% (*) 16.8% (*)
Group 3 (55 - 65) 13.1% 8.1% 17.9%
(*) = Dunnett test p < 0.05.
Table 3. Torsiometric parameters variation on unified data.
Plastoelasticity Variation vs. Baseline (%)
Parameter
T20 min T2 wks T4 wks
Ue −0.9% −16.6% (*) −16.8% (*)
Uf −1.5% −19.5% (*) −17.5% (*)
Uv −2.5% −24.3% (*) −18.7% (*)
Ur −4.9% −17.1% (*) −14.6% (*)
(*) Dunnett test: p < 0.05
Figure 1. Moisturizing activity on unified data.
rameters starting from T2wks, was observed. Even if a
trend decrease was present also for Group 1, a more
clinically important and statistically redensifying activity
was highlighted for Group 2 (Dunnett’s test p < 0.05 Uf
T2wks vs. T0 and Ue, Uf, Uv T4wks vs. T0) and Group 3
(Dunnett’s test p < 0.05 Ue, Uf, Uv, Ur T2wks vs. T0 and
Ue, Uf T4wks vs. T0) (Table 4).
The spectrophotometric analysis on pooled data did
not reveal any clinically important variation of spectrum
total area, but considering the separate groups a trend
towards increase of spectrum total area was shown for
Group 1 (+6.2% T20min, +4.3% T2wks and +2% T4wks vs.
T0).
Regarding the optical densitometry, no important vari-
ation was shown for skin brightness (L*) and redness
(a*), while a statistically significant reduction of skin
pigmentation (b*) was shown starting from T2wks (−3.3%
at T2wks and −3.0% at T4wks–Dunnett’s test p < 0.05
Table 4. Torsiometric parameters variation for separated
groups.
VARIATION % vs. T0
GROUP 1
T20 min T2 wks T4 wks
Ue 0.3% −11.1% −15.1%
Uf 0.6% −11.2% −14.0%
Uv 1.2% −11.5% −12.1%
Ur −10.5% −16.1% −18.5%
GROUP 2
Ue 2.3% −14.1% −19.9% (*)
Uf 1.4% −20.6% (*) −21.0% (*)
Uv −0.3% −32.2% (*) −23.1%
Ur −1.8% −15.4% −15.6%
GROUP 3
Ue −5.0% −23.7% (*) −15.6% (*)
Uf −6.0% −25.6% (*) −17.6% (*)
Uv −7.8% −28.8% (*) −20.8%
Ur −2.1% −19.7% (*) −9.6%
(*) Dunnett test: p < 0.05.
vs. T0); analysing the separate groups, a trend of reduc-
tion of skin pigmentation was demonstrated in particular
for Group 1 (−2.2% T20min, −4.9% T2wks and −3.9% T4wks
vs. T0).
The evaluation of the submental ptosis was performed
on frontal images taken in standardized conditions at T0,
T20min and T4wks and submitted to image analysis; in par-
ticular the measure considered facial coordinates of each
subject in order to identify the relaxed cutaneous area.
Results obtained on pooled data and on single study
group, did not highlight any significant variation of the
facial coordinates.
Regarding the clinical evaluation of the entire popu-
lation, the study product determined:
- a clinically important and statistically significant im-
provement of crow’s feet and cutaneous microrelief cli-
nical score already 20 minutes after the 1st product ap-
plication (Dunnett’s test p < 0.05 T20min, T2wks and T4wks
vs. T0), with a percentage of improved subjects at the end
of the study (at least one grade of improvement) respec-
tively of 79% and 76%;
- a statistically significant decrease of nasolabial folds
clinical score after 4 weeks of treatment (Dunnett’s test p
< 0.05 T4wks vs. T0) with 52% of improved subjects;
- a significant improvement of skin dullness clinical
score (the skin appears brighter) already 20 minutes after
the 1st product application (Dunnett’s test p < 0.05 T20min,
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An Innovative Concept Gel to Prevent Skin Aging
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276
T2wks and T4wks vs. T0), with a percentage of improved
subjects (at least one grade of improvement) of 67% after
4 weeks of treatment;
starting from the first product application corresponding
to a reduction of the clinical score of at least 1 grade, at
the end of the study, in 61% of treated subjects.
- a statistically significant improvement of skin tonic-
ity already after 2 weeks of treatment (resistance to trac-
tion: Dunnett’s test p < 0.05 T2wks vs. T0) and more
marked at the end of the study (resistance to pinching,
recovery after pinching, resistance to traction: Dunnett
test p < 0.05 T4wks vs. T0) with an improvement propor-
tion of at least 1 grade in 48%, 61% and 67% of subjects,
respectively;
Clinical evaluations, carried out at baseline (T0), 20
minutes after the 1st product application (T20min), after 2
(T2wks) and 4 (T4wks) weeks of treatment, are summarized
in the Spiderming™ graph (Figure 2).
Obtained results underline the anti-aging activity of
the study product: in fact, assuming that a larger graph
area corresponds to a more advanced state of skin ageing,
it is evident that, already after the 1st product application
and more consistently after 2 (T2wks) and 4 (T4wks) weeks
of treatment, a marked and clinically relevant reduction
- a statistically important reduction (Dunnett’s test p <
0.05 T20min, T2wks and T4wks vs. T0) of skin dryness
Figure 2. Clinical assessment at different time points on unified data.

An Innovative Concept Gel to Prevent Skin Aging 277
of the most considered clinical signs was achieved.
Looking at the Spiderming™ graphs for the separated
groups (Figures 3-5), the differences among the three
study populations at baseline (lower clinical scores for
Group 1 and higher for Group 3) and the different re-
sponses at the treatment were evident.
In particular for Group 1, a statistically significant de-
crease of crow’s feet clinical score (Dunnett’s test p <
0.05 T0 vs. T4wks) was present after 4weeks of treatment
with 73% of improved subjects; moreover, at the end of
the study, a clinically important improvement of surface
microrelief, resistance to traction (64% of improved sub-
jects) and of skin dullness (55% of improved volunteers)
were highlighted.
For Group 2 at the end of the treatment, a more marked
and statistically significant (Dunnett test p < 0.05 T0 vs.
T4wks) improvement of the main skin aging signs, was
found; crow’s feet, surface microrelief, skin dryness,
recovery after pinching and skin dullness improved re-
spectively in 73%, 82%, 82%, 82% and 64% of volunteers.
Moreover, a clinically important improvement of resis-
tance to pinching (on 64% of subjects) and resistance to
traction (on 55% of subjects) was found. On the oldest
population (Group 3), the significant improvement of skin
aging clinical signs was even more evident: crow’s feet
and surface microrelief statistically significantly im-
Figure 3. Clinical assessment at different time points on group 1.
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An Innovative Concept Gel to Prevent Skin Aging 278
Figure 4. Clinical assessment at different time points on group 2.
proved starting from T2wks (Dunnett’s test p < 0.05 T2wks
and T4wks vs. T0), with a percentage of improved popula-
tion respectively of 91% and 82%, both at T2wks and T4wks.
Nasolabial folds, skin dullness, recovery after pinching
and resistance to traction, significantly improved at the
end of the study (Dunnett’s test p < 0.05 T4wks vs. T0) on
73% (nasolabial folds) and 82% (all the other items) of
included subjects. Also the resistance to pinching (55% of
improved volunteers), the malar ptosis (45% of improved
subjects) and the skin dryness (64% of improved subjects)
showed a clinically important variation at the end of the
trial, compared to baseline.
Product cosmetic acceptability resulted good/excellent
in the opinion of the subjects enrolled. In particular, a high
percentage of volunteers appreciated product colour
(good-excellent = 97%), absorption (good-excellent =
97%), consistency (good-excellent = 91%), spreadability
(good-excellent = 100%) and the skin feeling (good-ex-
cellent = 94%). Moreover, the subjects underlined the
absence of oiliness (good-excellent = 91%) and of product
residues (good-excellent = 97%). The majority of volun-
teers (54%) did not appreciate the gel perfume before
application; however, once applied the product perfume
esulted more pleasing (61% = good-excellent). r
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An Innovative Concept Gel to Prevent Skin Aging 279
Figure 5. Clinical assessment at different time points on group 3.
At the end of the trial, almost all volunteers appreciated
the treatment efficacy. An improvement in skin smooth-
ness (27% medium, 43% marked and 30% very marked),
97% of deep wrinkles (45% medium, 42% marked and
10% very marked) and 94% of superficial wrinkles (36%
medium, 36% marked and 22% very marked) was ob-
served in 100% of subjects, while 58% of volunteers
reported an improvement in face silhouette (37% medium,
18% marked and 3% very marked). Moreover, 91% of
subjects observed an improvement in skin tonicity (30%
medium, 43% marked and 18% very marked), 88% of
skin brightness (36% medium, 42% marked and 10% very
marked) and 76% of skin dryness (28% medium, 21%
marked and 27% very marked).
All volunteers judged products safety as “good” or
“excellent” and these results were further confirmed by
the findings of the investigator who, during the entire
trial, did not record any type of adverse effect or event—
either related or unrelated to the product use.
4. Discussion
Common products used to prevent skin ageing may con-
tain hyaluronic acid which is a natural constituent of the
skin and has a certain documented anti-wrinkles activity
[13]. Hops extracts are also known for their antioxidant
properties and efficacy in improving skin structure and
Open Access JCDSA

An Innovative Concept Gel to Prevent Skin Aging 280
firmness has been reported [14]. On the contrary, ethanol
was never used before because it tends to cause skin
dryness and to remove the superficial lipid film. In the
tested formulation, the presence of ethanol was able to
synergise with both hyaluronic acid and hops by increas-
ing the effect of these ingredients in a previous in vitro
study [15].
This is the first study in vivo on human beings and the
obtained results strongly confirm the preliminary in vitro
screening, showing an excellent efficacy of the new gel
product as anti-skin aging treatment. In fact, the new anti-
age product gave excellent instrumental and clinical re-
sults, showing a statistically and clinically important re-
duction of skin roughness (smoothing/anti-wrinkle activ-
ity), a statistically important and clinically relevant im-
provement of skin firmness (firming activity), of skin
dryness (moisturizing activity), and in general, a statisti-
cally significant improvement of global skin rejuvenation
(anti-age activity).
The stratification by age of the enrolled subjects led to
further considerations: younger skins (Group 1) seem to
respond better to the treatment in terms of decrease of
roughness of the skin and of maximum decrease of the
depth wrinkle. Further on, younger skin had a more evi-
dent effect in increasing skin brightness and in reducing
skin pigmentation. Conversely, older skin (Group 3) was
the most sensitive to the treatment with the new gel in
terms of skin hydration, and this was more than expected,
as well as of skin firmness, probably induced by redden-
sifying activity of study product. Subjects belonging to the
intermediate age range (Group 2) apparently were those
who mostly benefitted from the study treatment: very
marked anti-wrinkle, firming and moisturizing activities.
5. Conclusions
In conclusion, the skin appeared less wrinkled, smoother,
more hydrated, more toned and brighter, therefore gener-
ally “younger” looking.
In line with a self-evaluation, the treatment activity was
considered as positive by a very high percentage of sub-
jects.
Finally, no adverse events occurred during the trial,
showing very good product safety and tolerability, con-
firmed also by the volunteers.
6. Conflict of Interest
The clinical study was 100% supported by Polichem SA
that is the holder of all rights related to the study. F.S.,
M.C. and F.M. are employees of Polichem SA.
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Open Access JCDSA