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‹N›
<=
/b>
A new formulation (SPHG800) containing hyaluroni=
c acid and 3 natural <=
/span>antibiotic
stimulators
is able to reduce irritative and infective <= /span>vulvitis symptoms
is able to reduce irritative and infective <= /span>vulvitis symptoms
Franco Vicariot=
to,
MD
Sinclair
Pharmaceuticals LTD
University of M=
ilan
– Department of Human
Morphology
![](3D"slide0046_image001.gif")
The vulvar surface is colonized by different microorganisms that are rarely
pathogenic, but may become pathogenic if the environmental <=
span
style=3D'font-size:133%;text-shadow:auto'>balance is affected.
=
The human body is able to counteract invading <=
span
style=3D'position:absolute;top:63.5%;left:-2.99%;width:106.17%;height:7.5%=
'>pathogens by production of na=
tural
antibiotic peptides, such as defensins.
&nb=
sp;
In particu=
lar
=
Beta-defensins
=
=
are
small cationic peptides with a strong antimicrobial activity against
Gram-negative bacteria and Candida albicans, together with a good bacterios=
tatic
activity against Gram-positive bacteria<=
span
lang=3DIT style=3D'font-size:133%'>.
![](3D"slide0058_image002.gif")
=
Experimental
data collected at University of
Milan
=
(Department of Human Morphology,&#=
13;
=
study
sponsored by Sinclair Pharmaceuticals Limited)
=
have
recently shown that
Hyaluronic
Acid
is able to induce skin keratinocyt=
es =
;
to produce =
; &n=
bsp; =
;
Beta-defensin 2
![](3D"slide0054_image003.gif")
The secretion of this peptide is further increased by the addition of 3 <=
/span>Natural
Antibiotic Stimulators (NAS): Arnica montana, Artemisia
absinthium and Sambucus nigra extracts.
![](3D"slide0048_image005.gif")
In the la=
st few
years, interest in the vulvar diseases has greatly increased.
<=
/i>
=
This impo=
rtant
pathology is being considered by the different specialties, including gynecology, dermato=
logy,
genito-urinary medicine, and pathology.
=
The spect=
rum of
involved specialties reflects the complexity of the vulvar diseases and the necessity of a multidisciplin=
ary
approach in the study of the vulva.
Vulvitis
can be of infective nature (vira= l, mycotic, bacterial), inflammatory nature = or contact allergic nature; recently the percentage of vulvitis symptoms caused by psychosomatic fac= tors has constantly increased.
can be of infective nature (vira= l, mycotic, bacterial), inflammatory nature = or contact allergic nature; recently the percentage of vulvitis symptoms caused by psychosomatic fac= tors has constantly increased.
Vulv=
itis is always present=
in
women’s life : adolescence, adult age, pregnancy and =
menopause.
<=
span
style=3D'mso-special-format:nobullet;display:none;font-family:Arial'>̶=
6;The main symptoms=
of
vulvitis are =
itch=
ing,
redness, pain.
<=
span
style=3D'mso-special-format:nobullet;display:none;font-family:Arial'>̶=
6;They often involve
physical, psychological and sexual
discomfort.
![](3D"slide0059_image006.gif")
=
• Less commonly, the
vulvar symptoms can be associated with allergic reactions.
Known allergens include :
topical medications
–various chemicals co=
ntained
in products such as perfumes, latex
excessive use of sanitary pads
underwear
Objective of the study
We want to evaluate the efficacy and the com= pliance of a new topical medical device
SPHG800
containing
low molecular weight Hyaluronic Acid and NAS<= span lang=3DIT style=3D'font-family:Tahoma;mso-ascii-font-family:Tahoma;mso-bid= i-font-family: Tahoma;mso-hansi-font-family:Tahoma;font-size:73%;text-shadow:auto'>
against irritative and infective vulvitis
We want to evaluate the efficacy and the com= pliance of a new topical medical device
SPHG800
containing
low molecular weight Hyaluronic Acid and NAS<= span lang=3DIT style=3D'font-family:Tahoma;mso-ascii-font-family:Tahoma;mso-bid= i-font-family: Tahoma;mso-hansi-font-family:Tahoma;font-size:73%;text-shadow:auto'>
against irritative and infective vulvitis
![](3D"slide0049_image007.gif")
Materials and methods =
3;
•The vulvar disease
was diagnosed for each patient during the
screening visit when the investigator assessed signs and symptoms <=
/span>such as itch=
ing,
redness and burning
•Patients were ask=
ed
to apply the cream to the vulva =
twic=
e a
day for 7/10 days
Mean age: 35 years (18-60)
![](3D"slide0007_image008.gif")
<=
span
lang=3DIT style=3D'mso-special-format:lastCR;display:none'>
Exclusion criteria
Pregnant women
=
;
• Patients undergoing topical or systemic =
treatments with
anti-inflammatory or antibiotic drugs
•
•Patients with autoimmune disorders or hypersensitive to=
any
of the product ingredients
![](3D"slide0052_image009.gif")
=
Efficacy parameters evaluated
during the study
Symptoms evaluated during the treatment were
=
![](3D"slide0044_image010.gif")
=
0 =3D no symptoms
1 =3D light
2 =3D moderate
3 =3D severe
• Itch
=
• Redness
• Burning
measured according to the following scale:=
![](3D"slide0056_image011.gif")
Baseline
parameters (n=3D24)
![](3D"slide0056_image013.gif")
![](3D"slide0056_image015.gif")
![](3D"slide0056_image017.gif")
![](3D"slide0056_image018.gif")
ITCH=
![](3D"slide0056_image019.gif")
REDNESS
![](3D"slide0056_image020.gif")
BURNING
![](3D"slide0057_image022.gif")
![](3D"slide0057_image023.gif")
Post-treatment effi=
cacy
(n=3D24)
![](3D"slide0057_image025.gif")
![](3D"slide0057_image027.gif")
![](3D"slide0057_image028.gif")
ITCH=
![](3D"slide0057_image029.gif")
REDNESS
![](3D"slide0057_image030.gif")
BURNING
![](3D"slide0037_image031.gif")
•At the end of the study all the
patients receiving
SPHG800
•reported a statistically
significant improvement of their condition =
and =
sh=
owed
a very good cosmetic ac=
ceptability.
The typical composition of the
product can highlight different me=
chanisms
of action which may explain this clinical result=
![](3D"slide0060_image032.gif")
It has been
demonstrated that
<=
/span>
SPHG800
is
efficacious and safe
both if
applied alone or in combination
with
classical antimicrobial compounds
![](3D"slide0055_image033.gif")
=
=
SPHG=
800 is able to contr=
ol
vulvitis symptoms, by inducing keratinocytes to =
produce Beta=
-defensin
2.
•
=
;
=
No bacterial resistence phe=
nomena
are known as regards to
•Beta=
-defensin
2
•&=
#13;
A prophylactic and long-ter=
m use
of these Beta-defensin stimulators is possible as ther=
apy
of vulvitis symptomatology
Fare clic per modificare gli stili del testo=
dello
schema
Secondo livello
Terzo livello
Quarto livello
Quinto livello
‹N›
Prodotte dalle superfici epiteliali<=
/div>
2
Peptides&n=
bsp;
proteine esistono
diverse defensine
Noi analizziamo le betadefensine che hanno =
un
livello basale
Keratinociti uguale cellule dell epidermide=
Betadefensine Attivate dall ac ial !!!
4
The extracts obtained from Arnica
montana, Sambucus nig=
ra and Artemisia absinthium are well-known from ancient times for their antimicrobial
and anti-inflammatory activity.
The extracts obtained from = Arnica montana, Sambucus nig= ra and Artemisia absinthium are well-known from ancient times for their antimicrobial
and anti-inflammatory activity.
The extracts obtained from = Arnica montana, Sambucus nig= ra and Artemisia absinthium
5
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