Post on 27-May-2018
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Swiss-American 2055 Luna Road, #126, Carrollton, TX 75006 1-800-633-8872 eltamd.com
S K I N C A R E
©2015 Swiss-American. All rights reserved. EltaMD is a registered trademark of Swiss-American. 88-534 Rev. 4/15
EltaMD®: The Science of Skin Care Delivered Safely
Available only throughapproved physicians.
EltaMD Barrier Renewal Complex Product Information Ceramide and enzyme therapy
• Visibly improves skin appearance• Promotes healthy skin barrier• Replenishes moisture
EltaMD® Barrier Renewal Complex is clinically proven to moisturize the stratum corneum and improve dry, compromised skin after a single application within 24 hours. This advanced formula works to visibly minimize the appearance of fine lines and wrinkles while significantly improving skin texture, tone and pore size. A selected blend of ceramides and other essential lipids help strengthen the barrier and restore its natural hydration system. Enzymes and vitamins minimize inflammation and promote skin cell turnover. Within 21 days, skin appears softer, smoother, healthier and more youthful. EltaMD Barrier Renewal Complex is fragrance-free, paraben-free, sensitivity-free and noncomedogenic.
Use to achieve and maintain a healthy skin barrier, replenish moisture and reduce the appearance of fine lines and wrinkles.
Apply morning and night to face, neck, and décolletage. For day-time use, follow with EltaMD sunscreen as directed by a physician.
1.7 oz / 48 g Airless pump
Varies by application amount and size of area covered
Purified Water, Ethylhexyl Isononanoate, Niacinamide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Ceramide NP, Cholesterol, Ceramide EOS, Cetyl Alcohol, Ceramide NS, Ceteareth-25, Ceramide EOP, Caprooyl Sphingosine, Caprooyl Phytosphingosine, Ceramide AP, Hyaluronic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xylitylglucoside, Squalane, Anhydroxylitol, PEG-7 Trimethylol-propane Coconut Ether, Polyisobutene, Piptadenia Colubrina Peel Extract, Actinidia Chinensis (Kiwi) Fruit Extract , Bromelain, Tocopherol, Xylitol, Ficin, Glutamine, Biotin, Proline, Behenic Acid, Carbomer, Citric Acid, Sodium Hydroxide, Butylene Glycol, Benzyl Alcohol, Potassium Sorbate, Phenoxyethanol, Hexadecanol, Sodium Bisulfite, Disodium EDTA.
Physician-dispensed only
02562
Label uses
Directions
Package size/dispenser
Applications per package
Ingredients
Availability
Item #
CERAMIDE& ENZYMEFORMULA
C
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AAD 2016 Poster Presentation on pages 3-4.
Dry
skin
may
be
indu
ced
by o
ne o
r mor
e fa
ctor
s su
ch
as lo
w h
umid
ity, l
ow e
nviro
nmen
tal t
empe
ratu
re, a
ging
, ps
ycho
logi
cal s
tress
, mic
roor
gani
sms,
and
/or e
xpos
ure
to c
hem
ical
s. U
se o
f moi
sturiz
ers
to c
omba
t sym
ptom
s of
dr
y sk
in a
re o
ften
the
first
treat
men
t opt
ion
to in
crea
se
skin
hyd
ratio
n. U
nfor
tuna
tely,
the
dry
skin
tran
sepi
derm
al
wat
er lo
ss c
an in
duce
infla
mm
ator
y cy
toki
ne re
leas
e an
d su
bseq
uent
infla
mm
ator
y ce
ll in
filtra
te. T
hese
co
mpl
ex in
tera
ctio
ns c
an th
en le
ad to
add
ition
al
infla
mm
atio
n an
d hy
perp
rolif
erat
ion.
Thi
s in
flam
mat
ion
cann
ot b
e re
solv
ed s
impl
y by
add
ing
moi
sture
to th
e str
atum
cor
neum
.
A m
oistu
rizer
that
can
hyd
rate
, pro
vide
pen
etra
ting
lipid
pro
files
(e.g
. cer
amid
es a
nd fa
tty a
cids
) and
in
gred
ient
s tha
t dec
reas
e in
flam
mat
ion
was
hyp
othe
sized
to
reso
lve d
ry sk
in sy
mpt
oms a
nd a
ssoc
iate
d in
flam
mat
ion
mor
e qu
ickly
than
a le
adin
g de
rmat
olog
ist re
com
men
ded
cera
mid
e co
ntai
ning
moi
sturiz
er. T
he te
st m
oistu
rizer
w
as d
evel
oped
and
teste
d in
dou
ble
blin
d ki
netic
and
us
age
clin
ical
stu
dies
com
pare
d to
con
trols.
Ski
n ap
pear
ance
, moi
sturiz
atio
n, s
moo
thne
ss, t
one,
por
e siz
e, fl
akin
ess,
ela
stici
ty a
nd s
kin
barri
er fu
nctio
n w
ere
asse
ssed
in 3
2 fe
mal
e su
bjec
ts (1
5 te
st: 1
7 co
ntro
l) w
ith d
ry o
r com
bina
tion
faci
al s
kin
usin
g bo
th o
bjec
tive
and
subj
ectiv
e m
easu
rem
ents.
DO
UBL
E BL
IND
RA
ND
OM
IZED
CLI
NIC
AL
STU
DY
O
N S
KIN
TEX
TURE
IM
PRO
VEM
ENT
WIT
H S
PEC
IALI
ZED
MO
ISTU
RIZE
RS
Mel
anie
C. T
imm
s¹ ,
Laur
a K.
S. P
arne
ll, B
S, M
Sc²
Swiss
‐Am
eric
an P
rodu
cts,
Inc.
Car
rollt
on, T
X¹; P
reci
sion
Con
sulti
ng, M
issou
ri C
ity, T
X
As e
xpec
ted,
bot
h pr
oduc
ts ha
d sig
nific
ant i
mpr
ovem
ents
in h
ydra
tion
and
skin
dry
ness
in a
s lit
tle a
s 4
hour
s an
d 24
hou
rs fo
llow
ing
a sin
gle
appl
icat
ion
as w
ell a
s du
ring
the
3 w
eek
study
per
iod.
Sig
nific
ant i
mpr
ovem
ents
in
TEW
L, sk
in to
ne, f
ine
flake
s, c
oars
e fla
kes
desq
uam
atio
n in
dex
valu
es w
ere
also
see
n fo
r bot
h pr
oduc
ts. H
owev
er,
signi
fican
t im
prov
emen
ts in
ext
ensib
ility,
pur
e el
astic
ity
and
biol
ogic
al e
lasti
city
mea
sure
men
t ove
r a 2
4 ho
ur
perio
d w
ere
only
obs
erve
d fo
r the
test
prod
uct g
roup
. Th
e te
st pr
oduc
t also
sig
nific
antly
redu
ced
pore
siz
e in
as
littl
e as
one
wee
k an
d th
roug
hout
the
entir
e stu
dy.
The
cont
rol m
oistu
rizer
was
sta
tistic
ally
out
perfo
rmed
fo
r por
e siz
e an
d vi
sible
sm
ooth
ness
. With
in 2
1 da
ys,
100%
of t
est p
rodu
ct s
ubje
cts
had
signi
fican
t visi
ble
and
tact
ile s
moo
thne
ss im
prov
emen
ts.
Use
of a
moi
sturiz
er c
onta
inin
g m
ultip
le in
gred
ient
s th
at
targ
et k
ey d
efic
ienc
ies
can
impr
ove
skin
text
ure
and
appe
aran
ce. B
reak
ing
the
dry
skin
cyc
le m
ay b
e of
use
in
mai
ntai
ning
hea
lthy
skin
and
impr
ovin
g co
mpr
omise
d sk
in q
uick
ly.
Abs
tract
Ack
now
ledg
men
ts &
Dis
clos
ures
Stud
y C
ondu
cted
by
Thom
as J.
Ste
phen
s &
A
ssoc
iate
s, In
c., R
icha
rdso
n, T
exas
and
Col
orad
o Sp
rings
, Col
orad
o
Stud
y fu
ndin
g sp
onso
red
in fu
ll by
Sw
iss-A
mer
ican
Pr
oduc
ts, In
c. (C
arro
llton
, Tex
as)
Intro
duct
ion
Dry
ski
n is
char
acte
rized
by
a la
ck o
f eith
er li
pids
, w
ater
or b
oth,
resu
lting
in ti
ghtn
ess,
flak
ing
and
infla
mm
atio
n. S
kin
may
app
ear d
ull,
espe
cial
ly o
n th
e ch
eeks
and
aro
und
the
eyes
. It m
ay la
ck e
lasti
city,
pr
esen
ting
acce
ntua
ted
fine
lines
and
wrin
kles
. In
mor
e se
vere
cas
es, i
tchi
ng a
nd b
urni
ng m
ay o
ccur
. Dry
ski
n ca
n be
gen
etic
ally
det
erm
ined
or t
rigge
red
by e
xter
nal
fact
ors
such
as
UV e
xpos
ure,
env
ironm
ent,
cosm
etic
s, o
r m
edic
atio
ns. I
t can
also
be
a na
tura
l con
sequ
ence
of
the
agin
g pr
oces
s, a
s se
bum
pro
duct
ion
slow
s do
wn.
8-62
5 R
ev. 3
/16
EltaMD® Barrier Renewal Complex is clinically proven to moisturize the stratum corneum andimprove dry, compromised skin in just 24 hours after a single application.
Sub. 1. Subject shows a statistically significant improvement in skin barrier function as measured by a decrease in transepidermal water loss, compared to untreated skin. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.
Sub. 21. Subject shows a statistically significant improvement in skin elasticity. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.
Sub.31. Subject shows a statistically significant improvement in skin smoothness and skin tone. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.
Sub. 5. Subject shows a statistically significant improvement in reduction of pore size, compared with baseline. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.
Clinical study on file.
ACKNOWLEDGEMENTSStephens and Associates Denver, CO.
This study was sponsored in full by EltaMD Skin Care, a division of Swiss-American©2016
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Dry skin may be induced by one or more factors such as low humidity, low environmental temperature, aging, psychological stress, microorganisms, and/or exposure to chemicals. Use of moisturizers to combat symptoms of dry skin are often the first treatment option to increase skin hydration. Unfortunately, the dry skin transepidermal water loss can induce inflammatory cytokine release and subsequent inflammatory cell infiltrate. These complex interactions can then lead to additional inflammation and hyperproliferation. This inflammation cannot be resolved simply by adding moisture to the stratum corneum.
A moisturizer that can hydrate, provide penetrating lipid profiles (e.g. ceramides and fatty acids) and ingredients that decrease inflammation was hypothesized to resolve dry skin symptoms and associated inflammation more quickly than a leading dermatologist recommended ceramide containing moisturizer. The test moisturizer was developed and tested in double blind kinetic and usage clinical studies compared to controls. Skin appearance, moisturization, smoothness, tone, pore size, flakiness, elasticity and skin barrier function were assessed in 32 female subjects (15 test: 17 control) with dry or combination facial skin using both objective and subjective measurements.
DOUBLE BLIND RANDOMIZED CLINICAL STUDY ON SKIN TEXTURE IMPROVEMENTWITH SPECIALIZED MOISTURIZERS
Melanie C. Timms¹ , Laura K. S. Parnell, BS, MSc²Swiss‐American Products, Inc. Carrollton, TX¹; Precision Consulting, Missouri City, TX
As expected, both products had significant improvements in hydration and skin dryness in as little as 4 hours and 24 hours following a single application as well as during the 3 week study period. Significant improvements in TEWL, skin tone, fine flakes, coarse flakes desquamation index values were also seen for both products. However, significant improvements in extensibility, pure elasticity and biological elasticity measurement over a 24 hour period were only observed for the test product group. The test product also significantly reduced pore size in as little as one week and throughout the entire study. The control moisturizer was statistically outperformed for pore size and visible smoothness. Within 21 days, 100% of test product subjects had significant visible and tactile smoothness improvements.
Use of a moisturizer containing multiple ingredients that target key deficiencies can improve skin texture and appearance. Breaking the dry skin cycle may be of use in maintaining healthy skin and improving compromised skin quickly.
Abstract
Acknowledgments & Disclosures
Study Conducted by Thomas J. Stephens & Associates, Inc., Richardson, Texas and Colorado Springs, Colorado
Study funding sponsored in full by Swiss-American Products, Inc. (Carrollton, Texas)
Introduction
Dry skin is characterized by a lack of either lipids, water or both, resulting in tightness, flaking and inflammation. Skin may appear dull, especially on the cheeks and around the eyes. It may lack elasticity, presenting accentuated fine lines and wrinkles. In more severe cases, itching and burning may occur. Dry skin can be genetically determined or triggered by external factors such as UV exposure, environment, cosmetics, or medications. It can also be a natural consequence of the aging process, as sebum production slows down.
8-625 Rev. 3/16
EltaMD
® Barrier Renewal Com
plex is clinically proven to moisturize the stratum
corneum and
improve dry, com
promised skin in just 24 hours after a single application.
Sub. 1.Subject shows a statistically significant im
provement in skin barrier function
as measured by a decrease in transepiderm
al water loss, com
pared to untreated skin. U
nretouched photographs of subject at baseline and after 21 days of twice-daily use
of EltaMD Barrier Renew
al Com
plex.
Sub. 21.Subject shows a statistically significant im
provement in skin
elasticity.U
nretouched photographs of subject at baseline and after 21 days of twice-daily
use of EltaMD Barrier Renew
al Com
plex.
Sub.31.Subject shows a statistically significant im
provement in skin sm
oothness and skin tone. U
nretouched photographs of subject at baseline and after 21 days of tw
ice-daily use of EltaMD Barrier Renew
al Com
plex.
Sub. 5.Subject shows a statistically significant im
provement in reduction of
pore size, compared w
ith baseline. Unretouched photographs of subject at baselineand after 21 days of tw
ice-daily use of EltaMD Barrier Renew
al Com
plex.
Clinical study on file.
ACKN
OW
LEDG
EMEN
TSStephens and Associates Denver, C
O.
This study was sponsored
in full by EltaMD Skin C
are, a division of Sw
iss-American
©2016
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The objective of this study was to measure a facial moisturizer that can hydrate, provide penetrating lipid profiles (e.g. ceramides and fatty acids) and ingredients that decrease inflammation to resolve dry skin symptoms and associated inflammation more quickly than a commercially available recommended ceramide containing moisturizer.
Objective
A statistically significant improvement in extensibility, pure elasticity and biological elasticity measurements over a 24 hour period were only observed for the test product group.
Comparisons between the test materials indicated that the test moisturizer outperformed the control, a leading ceramide-containing moisturizer, for improving visual smoothness at weeks 1 and 3, evenness of skin tone at weeks 2 and 3, and pore size at week 3.
Within 21 days, 100% of test product subjects had significant visible and tactile smoothness improvements.
Both moisturizers were tolerated well by the study panel throughout the three-week study period.
Conclusions
As seen in Table 1:
• Within 21 days, 100% of subjects had visibleand tactile smoothness in subjects using thetest product.
*Significant improvements in visible and tactilesmoothness in as little as one week and throughoutstudy for both products. See Figure 1.
*The test product significantly outperformed controlfor visible smoothness (p=0.04). See Figure 1.
• Significant improvements in moisturizing andskin dryness
*In as little as 4 hours and even after 24 hoursfollowing a single application for both products
*During entire 3 week study period for both products
• Significant reduction in pore size within oneweek and maintained throughout the entire studywith test product. See Figure 3.
*The test product outperformed control for pore sizereduction (p=0.04).
• Significant improvements in extensibility, pureelasticity and biological elasticity measurementover 24 hour period in test product subjects.
• Within one week, both products had significantimprovements in Skin tone, TEWL values, Fineand coarse flakes, Desquamation index. Figure 2
As seen in Figure 1, tactile and visual smoothness was improved and was statistically significantly improved for the test and control products.
As seen in Figure 2, skin smoothness and skin tone is improved over 3 weeks of twice daily usage.
As seen in Figure 3, pore size was visually and statisti-cally reduced over the study.
Statistically significant compared to Baseline * p<0.05
Statistically significant compared to Baseline ^ p<0.001Statistically significant compared between moisturizers # p=0.04
Results
Leveque, J. L., et al. “Biophysical characterization of dry facial skin.” J Soc Cosmet Chem 82 (1987): 171-177.
Byrne, A. J. “Bioengineering and subjective approaches to the clinical evaluation of dry skin.” International journal of cosmetic science 32.6 (2010): 410-421.
Hashizume, Hideo. “Skin aging and dry skin.” The Journal of dermatology 31.8 (2004): 603-609.
Rawlings, A. V., and C. R. Harding. “Moisturization and skin barrier function.” Dermatologic therapy 17.s1 (2004): 43-48.
References
This single-center, randomized, evaluator-blinded, controlled clinical trial was conducted to assess the efficacy and tolerance of the test moisturizer compared to a commercially available control moisturizer after a single application on the leg and twice daily for 3 weeks on the face.
A total of 32 female subjects aged 32 to 65 (mean age=50.3), with dry or combination facial skin completed the 3-week usage study and 16 subjects completed the 24-hour kinetic study. Subjects applied the assigned test or control moisturizer to the entire face twice per day.
Objective and subjective tolerance and clinical efficacy evaluations were performed by an expert grader at baseline, post-application, week 1, week 2 and week 3 of product use. Parameters assessed by an expert grader included tactile smoothness, visual smoothness, evenness of skin tone and pore size.
Bioinstrumentation measurements were taken at each time point using corneometer, cutometer, tewameter, D-squame discollection. Digital photography was also included in the study.
Methods
Fig. 2 Smoothness and Tone ImprovementCross-Polarized Front View; Test Subject
Sub31-C174: baseline Sub31-C174: week 3
Fig. 1 Smoothness Improvement vs. Baseline Table 1 Percent ImprovementFrom Baseline by Group
Fig. 3 Pore Size Reduction Improvement vs. Baseline
120
* **
100 100%
80
60
40
20
0
0
10
20
30
40
50
60
70
Perc
ent
Perc
ent
Baseline Week 1 Week 2 Week 3
Baseline Week 1 Week 2 Week 3
Test Control
** *
#
Measurement
Measurement 100.0%Visual Smoothness 82.4%Hydration 64.7%Pore Size 35.3%Coarse Flakes 58.8%
100.0%100.0%85.7%71.4%71.4%
TestMoisturizer
ControlMoisturizer
##
Tactile Test Visual Test Tactile Control Visual Control