AAD 2016 Poster Presentation on pages 3-4.
EltaMD Barrier Renewal Complex
Product Information
CERAMIDE
& ENZYME
FORMULA
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.
Label uses
Use to achieve and maintain a healthy skin barrier, replenish moisture and
reduce the appearance of fine lines and wrinkles.
Directions
Apply morning and night to face, neck, and décolletage. For day-time use,
follow with EltaMD sunscreen as directed by a physician.
Package size/dispenser
1.7 oz / 48 g Airless pump
Applications per package
Varies by application amount and size of area covered
Ingredients
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 Trimethylolpropane 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.
Availability
Physician-dispensed only
Item #
02562
EltaMD : The Science of Skin Care Delivered Safely
®
Swiss-American
1-800-633-8872
2055 Luna Road, #126, Carrollton, TX 75006
eltamd.com
S KIN CA R E
©2015 Swiss-American. All rights reserved. EltaMD is a registered trademark of Swiss-American.
88-534 Rev. 4/15
Available only through
approved physicians.
CY
T21
K
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.
CMY
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.
MY
T21
CM
Y
T0
M
T0
C
T0
T0
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.
8-625 Rev. 3/16
EltaMD ® Barrier Renewal Complex is clinically proven to moisturize the stratum corneum and
improve dry, compromised skin in just 24 hours after a single application.
T21
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.
T21
Clinical study on file.
ACKNOWLEDGEMENTS
Stephens and Associates
Denver, CO.
This study was sponsored
in full by EltaMD Skin Care,
a division of Swiss-American
©2016
Study funding sponsored in full by Swiss-American
Products, Inc. (Carrollton, Texas)
Study Conducted by Thomas J. Stephens &
Associates, Inc., Richardson, Texas and Colorado
Springs, Colorado
Acknowledgments & Disclosures
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.
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.
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.
Introduction
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.
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.
Abstract
Melanie C. Timms¹ , Laura K. S. Parnell, BS, MSc²
Swiss‐American Products, Inc. Carrollton, TX¹; Precision Consulting, Missouri City, TX
DOUBLE BLIND RANDOMIZED CLINICAL STUDY
ON SKIN TEXTURE IMPROVEMENT
WITH SPECIALIZED MOISTURIZERS
T0
M
Y
CY
T0
K
T21
T21
Clinical study on file.
ACKNOWLEDGEMENTS
Stephens and Associates
Denver, CO.
This study was sponsored
in full by EltaMD Skin Care,
a division of Swiss-American
©2016
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.
CMY
T0
MY
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.
CM
EltaMD ® Barrier Renewal Complex is clinically proven to moisturize the stratum corneum and
improve dry, compromised skin in just 24 hours after a single application.
T21
T21
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.
T0
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.
C
DOUBLE BLIND RANDOMIZED CLINICAL STUDY
ON SKIN TEXTURE IMPROVEMENT
WITH SPECIALIZED MOISTURIZERS
Melanie C. Timms¹ , Laura K. S. Parnell, BS, MSc²
Swiss‐American Products, Inc. Carrollton, TX¹; Precision Consulting, Missouri City, TX
Abstract
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.
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)
8-625 Rev. 3/16
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.
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.
Objective
Fig. 1 Smoothness Improvement vs. Baseline
Results
#
120
Methods
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.
•
Within 21 days, 100% of subjects had visible
and tactile smoothness in subjects using the
test product.
*Significant improvements in visible and tactile
smoothness in as little as one week and throughout
study for both products. See Figure 1.
•
•
Significant improvements in extensibility, pure
elasticity and biological elasticity measurement
over 24 hour period in test product subjects.
Within one week, both products had significant
improvements in Skin tone, TEWL values, Fine
and coarse flakes, Desquamation index. Figure 2
Bioinstrumentation measurements were taken at each
time point using corneometer, cutometer, tewameter,
D-squame discollection. Digital photography was also
included in the study.
As seen in Figure 1, tactile and visual smoothness was
improved and was statistically significantly improved
for the test and control products.
References
As seen in Figure 3, pore size was visually and statistically reduced over the study.
Leveque, J. L., et al. “Biophysical characterization of dry facial skin.”
Statistically significant compared to Baseline * p<0.05
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.
*
Measurement
Test
Moisturizer
Control
Moisturizer
Measurement
100.0%
100.0%
Visual Smoothness
100.0%
82.4%
Hydration
85.7%
64.7%
Pore Size
71.4%
35.3%
Coarse Flakes
71.4%
58.8%
20
0
Baseline
Tactile Test
Week 1
Visual Test
Week 2
Tactile Control
Visual Control
#
70
60
Test
Control
*
30
20
*
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.
50
40
Conclusions
Week 3
Fig. 3 Pore Size Reduction Improvement vs. Baseline
*During entire 3 week study period for both products
*The test product outperformed control for pore size
reduction (p=0.04).
*
40
Significant improvements in moisturizing and
skin dryness
Significant reduction in pore size within one
week and maintained throughout the entire study
with test product. See Figure 3.
*
60
*In as little as 4 hours and even after 24 hours
following a single application for both products
•
100%
80
*The test product significantly outperformed control
for visible smoothness (p=0.04). See Figure 1.
•
#
100
Percent
As seen in Table 1:
Percent
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.
Table 1 Percent Improvement
From Baseline by Group
*
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.
10
0
Baseline
Week 1
Week 2
Week 3
Fig. 2 Smoothness and Tone Improvement
Cross-Polarized Front View; Test Subject
As seen in Figure 2, skin smoothness and skin tone is
improved over 3 weeks of twice daily usage.
Statistically significant compared to Baseline ^
p<0.001Statistically significant compared between
moisturizers # p=0.04
Sub31-C174: baseline
Sub31-C174: week 3