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ORIGINAL RESEARCH
A Preliminary Clinical Evaluation of a Topical
Product for Reducing Slight Rosacea Imperfections
This article was published in the following Dove Press journal:
Clinical, Cosmetic and Investigational Dermatology
Daniele Maggioni
1
Annamaria Cimicata
1
Antonella Praticò
1
Roberta Villa
1
Ferdinando Marco Bianchi
1,2
Silvia Busoli Badiale
1
Claudio Angelinetta
1
1
Bio Basic Europe Srl, Milan, Italy;
2
Dermo-Cosmetic and Medical R&D
Center of Bio Basic Europe Srl, Milan,
Italy
Introduction: Rosacea is a chronic multifactorial skin disorder mainly affecting facial skin
with an estimated prevalence of about 5% worldwide. Its main symptoms, occurring early
during pathology development, are skin dehydration, redness, erythema, and telangiectasia.
Given the lack of a resolutive cure, therapeutic approaches able to relieve the main symptoms
are needed.
Purpose: The aim of this research article is to evaluate the beneficial effect of a topical product
(Serum BK46) on rosacea symptoms.
Patients and Methods: A monocentric single-arm, non-blinded study was performed to
assess the clinical effect of Serum BK46 in relieving the main symptoms of rosacea: skin
dryness, increased trans epidermal water loss (TEWL), redness, and abnormal vasculariza-
tion. Twenty patients with mild to moderate rosacea were enrolled in the study and asked to
apply the product twice per day for 56 days. Skin moisturization, TEWL, and erythema index
were instrumentally assessed at baseline and following 24 h and 14, 28 and 56 days of
treatment. Clinical parameters, including redness and telangiectasia imperfection visibility,
were evaluated on a 5-point scale by a specialized dermatologist at baseline and after 14, 28,
and 56 days of treatment. Finally, the visibility of vessel diameter was evaluated at baseline
and after 28 and 56 days of treatment.
Results: Serum BK46 application restored skin hydration and prevented the loss of water by
the skin. Long-term treatment with Serum BK46 significantly reduced skin redness,
erythema index, and the visibility of telangiectasia imperfections and superficial vessels.
The investigated product's clinical effect was demonstrated by both instrumental and clinical
evaluation. Furthermore, Serum BK46 was completely tolerated and no adverse effects were
recorded.
Conclusion: The moisturizing and skin barrier restoring action of Serum BK46 has been
clearly proven in patients displaying mild to moderate rosacea; thus, this product is a good
candidate for rosacea treatment.
Keywords: rosacea, topical product, transepidermal water loss, skin redness, telangiectasia
Introduction
Rosacea is a common inflammatory skin disorder, affecting prevalently the nose,
chin, and central forehead and in some cases the periocular areas.
1
Its etiology and
pathophysiology are still largely unknown.
Rosacea is a diffuse pathology affecting more than 15 million patients in
USAthe only, while its prevalence is estimated between 5% and 10% worldwide.
1,2
Furthermore, the incidence of rosacea is increasing in developed countries,
probably because of the aging populations. Rosacea is more prevalent in fair-
skinned people, especially among European Caucasians, but it has also been
Correspondence: Annamaria Cimicata
Tel +39 02 4155729
Fax +39 0242174243
Email annamariacimicata@libero.it
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reported in people of other ethnicities.
3
Females and
males are equally affected, although the manifestations of
the pathology may vary according to gender.
4
The highest
prevalence of the pathology is found among people in the
age range between 45 and 60 years.
1
Although rosacea etiology remains not completely
understood, it seems to be multifactorial, comprising
both a genetic predisposition and environmental factors
that can promote an exaggerated vasodilation and water
loss.
5
For instance, rosacea may be initiated or aggravated
by several trigger factors, such as cold, heat, ultraviolet
irradiation, and dermal or oral exposure to chemicals.
4
Based on morphological characteristics, rosacea may
be classified into four groups: ocular, erythethematotelan-
giectatic, papulopustular, and phymatous. Ocular rosacea
affects the periocular zone, whereas erythematotelangiec-
tatic, phytamous and papulopustular rosacea arise in the
middle of the face and they primarily include telangiecta-
sia, erythema, and flushing.
6
Primary symptoms are
usually associated with secondary features such as burn-
ing, itching, and stinging sensation on the face.
7
The unknown etiology and the intrinsic heterogeneity
of manifestations of rosacea have hampered the efficacy of
treatments. In fact, although several therapeutic options
such as topical application of vasoconstrictive or anti-
inflammatory creams or laser treatments are used,
a proper cure for this disorder does not exist and current
treatments usually address and manage only some symp-
toms of the pathology.
6
Although it is not considered a severe pathology, the
psycho-social impact of rosacea is often underrated; in
fact, the pathology deeply impacts patients’quality of
life, as the negative self-perception of the patient may
lead to psychological co-morbidity. For instance, epide-
miological data reported an increased depression rate
among patients with rosacea.
3
Pharmaceutical research for novel rosacea treatment is
somewhat limited if compared with research in other
inflammatory skin diseases. It is unlikely that a single
therapeutic modality will result in complete and long-
lasting resolution of rosacea. In mild to moderate disease,
topical approaches are the first-line treatment and they
comprise a broad spectrum of formulations including
metronidazole, azelaic acid, clindamycin lotion, perme-
thrin 5% cream, tretinoin cream, 10% sulfacetamide with
sulfur (5%), and benzoyl peroxide alone or in combination
with erythromycin or clindamycin.
8
These approaches are
not always completely effective; moreover, these pharma-
cological treatments can be used for a limited time only.
The Serum BK46 applied in this study is a topical
formulation based on skin moisturizing, relieving, and
protecting agents, that help to increase the cutaneous bar-
rier function, thus preventing skin dehydration and protect-
ing the skin from all the environmental factors that may
promote and exacerbate the pathology symptoms. In parti-
cular, Serum BK46 contains a combination of ingredients
such as potassium azeloyl diglycinate, squalane, dipotas-
sium glycyrrhizate, Aloe barbadensis leaf juice, sodium
hyaluronate, polyacrylate crosspolymer-6, and xanthan
gum, that synergistically act to normalize and relieve rosa-
cea symptoms.
Potassium azeloyl diglycinate, thanks to the presence
of glycine, possesses a moisturizing effect and helps to
maintain skin hydration levels, so the affected skin stays
moisturized, allowing the physiological healing process
through restoring skin balance conditions on the compro-
mised area. Squalane is an oily substance that acts as
a lubricant on the skin surface; it functions as an emollient
for topical application in creams, lotions, ointments, lip-
sticks, and other cosmetics. Dipotassium glycyrrhizate is
a skin conditioning/humectant (as per cosmetic indica-
tions) and it is used in cosmetic formulations (FDA
2002) at a maximum concentration of 1% (CTFA 2003).
Xanthan gum is a polysaccharide used as an emulsion
stabilizer and gelling agent and it is globally recognized
as a film former. Hyaluronic acid is a well-known humec-
tant and skin-conditioning polysaccharide distributed
widely in the extracellular matrix of human connective
tissue. Due to high molecular weight, it is considered to
help the creation of a moisturizing film on the skin surface.
Polyacrylate crosspolymer-6 is a high molecular weight
polymer able to deposit over the outer layers of the skin/
mucosae. It works with other ingredients and helps to
create a barrier to restoring skin and preventing water
loss and hydrating tissues.
Aloe barbadensis leaf juice is the juice expressed from
the leaves of the aloe, Aloe barbadensis, Liliaceae. It
functions as a film former, humectant, skin-conditioning
agent (emollient).
Given the high incidence and the psycho-social impact of
the pathology, rosacea treatment represents an unmet clinical
need; therefore, the aim of this pilot study was to evaluate the
effect of Serum BK46 in the alleviation of rosacea symp-
toms. In particular, the effect of Serum BK46 in reducing
rosacea signs has been analyzed by measurement of skin
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moisturization, transepidermal water loss (TEWL), capillary
diameter and erythema index and by clinical visual evalua-
tion of clinical parameters such as redness and visibility of
telangiectasia associated skin imperfections.
Materials and Methods
A single-site study of Serum BK46 for the treatment of
rosacea was conducted in 2017 at Dermo-Cosmetic and
Medical R&D Center of Bio Basic Europe (Milan, Italy).
All subjects, enrolled in a single cohort, provided written
informed consent prior to entering into the study. The trial
was run in accordance with the Declaration of Helsinki
(2013) and with principles of good clinical practices. The
study protocol was approved by the internal ethics com-
mittee of the Medical R&D Center of Bio Basic Europe.
According to the structure of the study, both patients and
examiners were not blinded. Data were obtained, recorded,
and processed in accordance with the International
Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH)
guidelines for good clinical practice.
Healthy subjects (n=20), with an age between 30 and
65 years, have been selected for the investigation.
Following a baseline clinical visit, patients with dry skin,
reddened skin, and imperfections caused by telangiectasia
(mild to moderate rosacea) were included in the study.
Patients were excluded from experimentation in the case
of dermatopathies, if they consume oral or topic drugs,
or if they complained of psychological diseases. Moreover,
patients were required to not change their usual daily
routine. Before taking any measurement, the patients
were accommodated in a room with a controlled atmo-
sphere (20°C, RH 40–60%) for a period of time.
We hereby acknowledge the company Biokosmes s.r.l.
for providing the product involved in this study.
Method of Application of the Test Samples
Samples of the tested product have been applied on the
face skin twice per day (in the morning and in the evening)
after routine cleansing, for 56 consecutive days.
At the beginning and throughout the entire experimen-
tation, at selected time points (after 24 h, 14 days, 28 days
and 56 days of treatment), instrumental evaluations of skin
moisturization, transepidermal water loss (TEWL), and
erythema index were conducted. In addition, clinical eva-
luation of skin redness and telangiectasia imperfections
were performed at the beginning of the study and after
14, 28, and 56 days of treatment.
Instrumental Evaluation of Skin Parameters
Skin moisturization was measured by the use of a -
corneometer
®
CM 825 (Courage and Khazaka, Koln,
Germany). Briefly, the corneometer measures the electric
capacity of the skin surface that is related to skin moisture:
both electric capacity and the conductance of biological
tissue change according to the water content, ie, they
increase if the water content increases. This instrument
translates the electrical parameters in moisturization units
(scale: 0–130).
The TEWL was evaluated through the TEWAMETER
®
TM 300 (Courage and Khazaka, Koln, Germany); this instru-
ment indicates the TEWL, in terms of quantity of evaporated
water for the considered skin unit. The method measures the
gradient of steam tension between two electrodes located at
different distances from the skin surface. The method allows
the corneal layer integrity and functionality of the skin bar-
rier to be evaluated.
The erythema index was analyzed by using the Mexameter
MX18 (Courage and Khazaka, Koln, Germany), which mea-
sures the absorption capacity of the skin. The instrument emits
light at two different wavelengths and measures the light
reflected by the skin. Since the amount of light emitted is
known, the quantity of light absorbed by the skin can be
calculated. Two wavelengths were used: 568 and 660 nm,
corresponding to the absorption peak of hemoglobin and
color influencers such as melanin bilirubin, respectively. The
erythema index was calculated from the digitized results
obtained in a 0–999 scale as a function of skin absorption at
568 nm minus absorption at 660 nm.
Blood capillary diameter measurements were per-
formed by using VIDEOCAP
®
, Video–Capillaroscopy
with a tube (D-S Medica, Milan, Italy). The instrument
measures the diameter of vessels at the level of arboreal
telangiectasias and capillary loops’linear branches, clearly
visible during the videodermatoscopic evaluation.
The instrument is put on the specific skin areas and images
are recorded and subsequently analyzed at 200× magnifica-
tion. Vessel diameter is calculated using VIDEOCAP
®
soft-
ware and expressed in mm. Each recorded measure is the
average of 10 measurements performed on 10 vessels.
In addition, images of the telangiectasia lesions were
taken by the use of Miravex Antera 3D.
Clinical Evaluation
Clinical evaluation was performed through visual assess-
ment by a dermatologist and the results were recorded
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according to the rosacea scoring system as reported by
Wilkin and coworkers
1
with minor modifications, so that
primary signs of rosacea were graded as absent, slight,
mild, severe, and very severe in a range from 1, very
severe, to 5, absent. Parameters used to evaluate skin red-
ness and imperfection visibility and their scoring system
are reported in Table 1.InTable 2 are shown the compar-
ison of clinical evaluation of rosacea symptoms (skin red-
ness and telangiectasia imperfection visibility) score at
baseline (before treatment = T0) and after 14, 28, and 56
days of Serum BK46 application.
Patient-Reported Outcome
At the end of treatment (T56) patients were asked to fulfill
an end of study questionnaire, which evaluated the
patient’s opinions about the product's effects, with parti-
cular focus on the feeling of skin dryness, skin burning,
and redness. This self-evaluation was performed according
to a VNS (visual numeric scale) scale where 0 is the
minimum value and 10 is the maximum value. Scores
above or equal to 7 have been considered as positive.
Statistical Evaluation
Statistical analysis of short term (24 h) Serum BK46 effect
on skin moisturization was performed by non-parametric
Wilcoxon signed-rank test.
Statistical evaluation of long-term effect for instrumen-
tal parameters (skin moisturization, TEWL, erythema
index) was performed using analysis of variance by one-
way repeated-measures ANOVA, after assumption verifi-
cation. When the test results were statistically significant,
the Student's t-test Bonferroni correction was applied as
a post hoc test to compare the differences among different
timepoint groups. The long-term effect was assessed sepa-
rately from the short-term effect and T24 has been mea-
sured separately from T14, T28, and T56 where the
ANOVA was performed.
Statistical evaluation of the long-term effect on vessel
diameters and on clinical data (telangiectasia imperfection
visibility and skin redness) obtained at different time
points was performed by the non-parametric Friedman
test followed by Wilcoxon signed-rank Bonferroni cor-
rected test.
The calculation of the sample size for this pilot study
was not performed; however, the sample size was defined
based on a previously published study on the efficacy of
rosacea treatment.
9–11
Results
The study included 20 subjects with rosacea on both sides
of the face and all patients enrolled successfully completed
the study. Each subject received Serum BK46 twice
per day, with the application on skin face for 56 days.
The Serum BK46 effect was evaluated instrumentally
by measuring the hydration of the skin by the use of
a corneometer.
The increase of skin moisturization promoted by Serum
BK46 was already evident following 24-h application, in
fact, as illustrated in the graph of Figure 1, a significant
increase in skin hydration was observed at T24h if compared
with T0, as the medians of moisturization values were 42.5
and 45.5, respectively (p<0.01 Wilcoxon signed-rank test vs
T0). The other parameters evaluated, erythema index and
skin redness, did not show any significant variation after
short treatment (24 h), data not shown.
In long-term treatment, the hydration index steadily
increased from T14 until the end of the treatment. There
was a significant difference between skin hydration at
baseline and after product application; in fact, the mean
skin moisturization index was 42.5 ± 3.9 at T0 and
climbed up to 44.1 ± 3.7; 47.6 ± 3.5 and 49.7 ± 3.5
following 14, 28, and 56 days of treatment (p-value
<0.01). The skin moisturization progress during the study
is shown in the graph of Figure 2.
Table 1 Clinical Evaluation Parameters
Redness Score Description
Very evident 1 Very evident skin redness
Evident 2 Evident skin redness
Moderate 3 Moderately visible skin redness
Slight 4 Slightly visible skin redness
Absent 5 No skin redness
Telangiectasia
imperfection
visibility
Score Description
Very evident 1 Very evident imperfections
caused by telangiectasia
Evident 2 Evident imperfections caused by
telangiectasia
Moderate 3 Moderately visible imperfections
caused by telangiectasia
Slight 4 Slightly visible imperfection
caused by telangiectasia
Absent 5 No visible imperfection caused
by telangiectasia
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A progressive decrease of TEWL was noted throughout
the treatment with Serum BK46, reaching a statistically sig-
nificant difference in comparison with T0 following 14, 28
and 56 days of application. Indeed, as reported in the graph of
Figure 3, the mean TEWL (g/(h*m
2
)) observed at T0 was 15
± 3.1, whereas at T14, T28, and T56 it was respectively 14.3
± 2.9; 12.9 ± 2.7, and 12.2 ± 2.3 (p-value <0.01 vs T0, one
way ANOVA, Student’stpost-test).
The improvement in the hydration parameters was
accompanied by a reduction of skin erythema, in particu-
lar, a statistically significant decrease of erythema index
was observed after 14, 28, and 56 days of Serum BK46
application, since baseline erythema index was 491 ± 82.5
at T0 but it dropped to 459.2 ± 79.5, 438.6 ± 80.3, and
425.4 ±78.7 (p-value <0.05) following 14, 28, and 56 days
of application, respectively, as can be observed in the
graph of Figure 4.
Furthermore, a slight, but statistically significant reduc-
tion of the capillaries’diameter was recorded following
treatment; indeed, the median vessel diameter, measured at
the level of arboreal telangiectasia, was 0.130 (Q1 0.081;
Q3 0.212) mm at baseline (T0) and decreased to 0.119 (Q1
0.068; Q3 0.188) mm and 0.112 (Q1 0.068; Q3 0.173) mm
following, respectively, 28 and 56 days of product applica-
tion: data are reported in the graph of Figure 5.
The reduction of erythema and telangiectasias was
highlighted also by visual inspection at the end of treat-
ment. Indeed, as reported in Figure 6, showing images
taken at baseline and by the end of treatment, significant
mitigation of both signs was highlighted by the reduction
of superficial hemoglobin distribution following Serum
BK46 application.
Clinical evaluation of skin redness and visibility of tel-
angiectasia imperfections confirmed the effect of Serum
Table 2 Clinical Evaluation of Rosacea Symptoms (Skin Redness and Telangiectasia Imperfection Visibility), Score at Baseline (Before
Treatment = T0) and After 14, 28, and 56 Days of Serum BK46 Application
Grade Skin Redness
T0 T14 T28 T56
% (n) % (n) % (n) % (n)
Very evident
(very evident skin redness)
25% (5) 20% (4) 10% (2) 10% (2)
Evident
(evident skin redness)
60% (12) 50% (10) 50% (10) 40% (8)
Moderate
(moderately visible skin redness)
15% (3) 30% (6) 30% (6) 30% (6)
Slight
(slightly visible skin redness)
0% (0) 0% (0) 10% (2) 20% (4)
Absent
(no skin redness)
0% (0) 0% (0) 0% (0) 0% (0)
Grade Telangiectasia Imperfection Visibility
T0 T14 T28 T56
% (n) % (n) % (n) % (n)
Very evident
(very evident imperfections caused by telangiectasia)
20% (4) 20% (4) 15% (3) 5% (1)
Evident
(evident imperfections caused by telangiectasia)
55% (11) 55% (11) 45% (9) 50% (10)
Moderate
(moderately visible imperfections caused by telangiectasia)
20% (4) 20% (4) 25% (5) 25% (5)
Slight
(slightly visible imperfections caused by telangiectasia)
5% (1) 5% (1) 15% (3) 20% (4)
Absent
(no visible imperfections caused by telangiectasia)
0% (0) 0% (0) 0% (0) 0% (0)
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BK46 in reducing the main signs of rosacea, estimated
according to the 5-point score shown in Tabl e 1.InTabl e 2
is shown the comparison of clinical evaluation of rosacea
symptoms (skin redness and telangiectasia imperfection vis-
ibility) score at baseline (before treatment = T0) and after 14,
28, and 56 days of Serum BK46 application. Before treat-
ment, the majority of patients (85%) were graded as “severe”
or “very severe”for skin redness, whereas this percentage
declined to 60% and 50% following 28 and 56 days of Serum
BK46 application, respectively. Statistical evaluation per-
formed by the non-parametric Friedman test, followed by
Wilcoxon signed-rank post-test to compare the variations
among the different time points, underlined a statistically
significant difference in comparison with baseline (T0) fol-
lowing 28 and 56 days of treatment (p<0.05 T28 vs T0;
p<0.01 T56 vs T0).
Figure 1 Short-term skin moisturization evaluated by a corneometer, reported as median ± first and third quartiles at T0 and following 24 h of product application (T24h).
*p<0.01 vs T0 Wilcoxon signed-rank test.
Figure 2 Long-term skin moisturization evaluated by a corneometer, reported as mean ± standard error measured throughout the study, from T0 to T56. One-Way
ANOVA test and Student's tBonferroni corrected post hoc test (*p<0.01 versus T0).
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Similarly, a general reduction of telangiectasia imper-
fection visibility was observed by the end of treatment. In
fact, the percentage of patients having severe or very
severe imperfection visibility was 75% at baseline, but
significantly declined to 60% and 55% after 28 and 56
days of product application. The difference between T56
and baseline was statistically significant, p-value <0.01.
Discussion
This study aims to evaluate the clinical effect of a Serum
BK46, a product ideated for topical application for the
treatment of the main signs of rosacea. In particular, the
outcomes of long-term product application have been ana-
lyzed in patients with mild to moderate rosacea. Serum
BK46 is a proprietary composition, including potassium
azeloyl diglycinate, squalane, dipotassium glycyrrhizate,
Aloe barbadensis leaf juice, sodium hyaluronate, polya-
crylate crosspolymer-6, and xanthan gum; the efficacy of
these ingredients against some of the rosacea signs has
already been demonstrated.
11,12
Rosacea is a chronic skin disorder that severely affects
patient quality of life, since erythema, telangiectasia
Figure 4 Skin erythema index as evaluated by Mexameter-M18 throughout the study, the mean and standard error are reported. A steady decrease in skin associated
erythema was observed. One-way ANOVA test and Student's tBonferroni corrected post hoc test (*p<0.01 vs T0).
Figure 3 Long-term trans epidermal water loss (TEWL) measured by Tewameter. A regular decrease in the rate of skin dehydration was recorded during the study. One-
way ANOVA test and Student's tBonferroni corrected post hoc test (*p<0.01 vs T0).
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imperfections, and other major symptoms mainly affect
the facial skin, thus undermining patients’physical
appearance.
9
Indeed, patients usually suffer psychological
discomfort and emotional stress due to the high visibility
of pathology signs and this negative self-perception may
lead to anxiety disorders.
Although a proper and well-defined cure for rosacea is
far from being found, novel treatments that may control
and relieve some symptoms may significantly improve
patients’quality of life. Additionally, given the lack of
an exhaustive treatment, a successful approach may be
the avoidance of the triggering factors.
Figure 6 A sample image showing the reduction of superficial hemoglobin distribution in the cheek area at baseline and by the end of treatment, images detected and
analyzed with Miravex Antera 3D.
Figure 5 Vessel diameter as measured by Viodecap and reported as median with first and third quartile. *p-value <0.01 Friedman rank test, Wilcoxon-signed rank
Bonferroni corrected post hoc test.
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The etiology of rosacea is still largely unknown; how-
ever, one of the triggering factors seems to be the damage to
the skin barrier function. Indeed, one of the main functions of
the skin is to provide an effective barrier to curtail the
penetration of microbes and allergens into the body. Some
studies have proven that alterations of skin barrier may
promote skin disorders and defective expression of proteins
involved in the correct setup of the skin barrier has been
reported during rosacea progression.
5,13
An altered barrier
function is mainly visible by increased water loss, also pro-
moted by the altered epidermal vascularization.
5
Several clinical parameters have been used to assess
the effect of Serum BK46 on symptom severity, including
both instrumental techniques and clinical assessment to
evaluate skin hydration, water loss, skin redness,
erythema, and telangiectasias.
Serum BK46, due to its proprietary composition based
on hydrating and skin protective agents, maintains skin
hydration and restores the skin barrier function:
a protective film is created over the skin, thus enforcing
the cutaneous barrier and reducing the impact of environ-
mental factors that could otherwise exacerbate the patho-
logical signs. The data reported in this clinical study
demonstrated that Serum BK46 application results in
a diminished TEWL already after 14 days of treatment
and the differences were statistically significant after 14,
28 and 56 days if compared with baseline (T0). TEWL is
the amount of water that evaporates through the skin and is
used to describe skin barrier function as a shift from
normal values to high levels indicates an impaired barrier
functionality. In healthy subjects, TEWL of skin face
reference value may be considered as 13 g/(h*m
2
).
14
The
range of TEWL observed in rosacea patients enrolled in
this study, as expected, was higher than the expected
normal range, but long-term treatment with Serum BK46
could decrease TEWL to values in the normal range.
As a consequence of skin barrier restoration and due to
the moisturizing agents contained, Serum BK46 also sig-
nificantly increases skin hydration, which steadily rose
throughout the treatment, reaching a marked increase fol-
lowing 14, 28, and 56 days of product application. These
clinical findings have been confirmed also by patients’
opinions, since in a self-administered questionnaire
patients reported a marked reduction of dryness feeling
following Serum BK46 treatment. This result is remark-
able as the Serum BK46 application not only significantly
relieves some of the main symptoms of rosacea, but it also
improves the patient's self-perception about the impact of
pathology-associated imperfections.
The restoration of skin hydration and the concomitant
reduction of water loss would be of interest also to
increase skin wound healing capability.
15
The enhancement in skin hydration and barrier func-
tion is also accompanied by a normalization of the visibi-
lity of skin imperfections caused by telangiectasias. In
particular, the instrumental measurements highlighted
a progressive decrease in the visibility of superficial ves-
sels and skin redness during treatment, reaching
a statistically significant difference in comparison with
baseline after 14, 28, and 56 days of Serum BK46 applica-
tion. Skin hydration is one of the most important para-
meters to be evaluated in rosacea, for instance, several
new treatments have been recently developed in order to
improve the same parameters analyzed in this study.
16,17
Furthermore, treatment with Serum BK46 significantly
attenuated the visibility of telangiectasia imperfections,
one of the most negative factors for facial perception
associated with rosacea. In particular, both instrumental
and clinical evaluation confirmed the decreased visibility
of such dermal imperfection.
It is noteworthy that this reduction was evident during
all the treatment periods, lasting 56 days; thus, strongly
indicating that long-term product application could be an
effective therapeutic strategy.
In addition, the product showed an optimal tolerability,
as it did not induce any adverse effects and it could be
applied safely for 8 weeks. Moreover, the majority of
patients asked to state their opinions about the Serum
BK46 effect judged the product effective in reducing
skin redness and telangiectasia imperfection visibility
(over 70%) and the feeling of skin dryness and burning
(over 75%). The good rate of patient self-evaluation fol-
lowing Serum BK46 application is remarkable since, as
stated above, a detrimental physical appearance perception
is one of the primary factors worsening the quality of life
for rosacea patients.
The preliminary results coming from this pilot study
underline the clinical effect even in the long-term treat-
ment of Serum BK46 in relieving some of the main rosa-
cea symptoms. However, the power of this study is limited
by the small number of subjects and by the absence of
a control/placebo group; therefore, future studies should
confirm these results in a larger group of patients including
a placebo group or a split-face evaluation to provide even
stronger evidence of Serum BK46 effectiveness.
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DovePress 307
Conclusion
In conclusion, the results provided in this clinical study
demonstrate the Serum BK46 effect in mitigating rosacea
symptoms. Furthermore, its optimal tolerability even fol-
lowing long-term application makes Serum BK46 an ideal
candidate for the long-term management of mild to mod-
erate forms of rosacea.
Ethics and Consent Statement
This manuscript has not been published or submitted else-
where for publication and it is not under consideration by
another journal. The authors have read and understood the
journal’s policies and believe that neither the manuscript
nor the study violates any of these.
Disclosure
The authors report no conflicts of interest in this work.
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