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ULTRA EYE SERUM™ Clinical Study XERIDIAN® CLINICAL SKINCARE® 2 General Discussion The Ultra Eye Serum™ utilizes botanical phytopeptides, natural prohormones, and bioflavonoids to diminish the visibility of dark circles and puffiness while a broad spectrum of anti-aging polypeptides actively work to correct the appearance of lines and deeper wrinkles around the eyes. This collagen-promoting action is furthered by l-carnosine amino-peptides, which prevent and reverse Advanced Glycation End (AGE) products that are the result of fusions between proteins and sugars. This undereye serum additionally contains Olive Leaf, Acai Berry, Green Tea, Red Tea, White Tea, and Ginkgo Biloba extracts that saturate eye-area skin in antioxidant phytonutrients to fight free radical damage and calm inflammation. o Correction Of Eye Area Wrinkles – With the broadest spectrum of anti-aging Dipeptides, Tripeptides, Pentapeptides, Oligopeptides, Tetrapeptides, L-Carnosine Amino-Peptides, and GHK Copper Peptides in the industry this formula dramatically reduces the appearance of lines and deeper wrinkles by facilitating an increase in collagen synthesis. As collagen density increases so does skin thickness and elasticity. This formula also contains L-Carnosine Amino-Peptides that numerous clinical studies have shown can not only prevent the formation of Advanced Glycation End (AGE) products in the skin (when proteins and sugars fuse together), but can actually reverse damage done by this deleterious process. o Lightening Dark Circles & Diminishing Undereye Puffiness – Soy Amino-Peptides, Rice Bran Amino-Peptides, Bioflavonoids, and Natural DHEA Prohormones take an active role in aiding in the repair of vascular walls to discourage the pooling of blood, iron, and hemoglobin that cumulatively appear as dark circles. This not only promotes proper microcirculation but also encourages the draining of excess fluids and swelling that contribute to puffiness. o Immediate Perceivable Effects – The Natural GABA Neuropeptides and microcirculation-enhancing Coffea Arabiga Seed Extract in this formula produce a noticeably softer relaxation to peri-orbital skin and clarification of puffiness within minutes of application that compliments the long-term anti-aging results achieved by the amino-peptides and other undereye clarifying compounds. o Defense Against Free Radicals – Phytonutrients saturate the skin in antioxidants that defend against free radical damage. We have included here the therapeutic extracts of Acai Berry (rich in anthocyanins), Olive Leaf (rich in oleuropein), Green Tea (rich in polyphenols and EGCG), Red Tea (rich in superoxide dismutase), White Tea (rich in catechins), and Ginkgo Biloba (rich in flavonoids and terpenoids) to offer superior antioxidant support to facial skin. Formula Active Mechanisms Undereye Clarifying Compounds Soy & Rice Bran Amino-Peptides Functions to improve microcirculation by repairing the dense capillary network of the undereye area to reduce the leakage of pigmented hemoglobin that causes dark circles and simultaneously prevents fluid leakage that results in puffiness. These specially purified soy and rice bran proteins also protect the integrity of the underlying collagen/elastin network and reduce the harmful effects of UV radiation on skin. In-vivo tests have confirmed visible results after only 4 weeks with best results after 10 weeks of use. There are a broad range of bioflavonoids in nature that provide several benefits for the skin. In this formula Hesperidin Bioflavonoids are utilized to dramatically reduce the appearance of chronic bags under the eyes. This natural compound targets the main causes that contribute to the formation of bags or puffiness under the eyes: prevention of fluid leakage by reducing capillary permeability, elimination of excess fluids to relieve the puffiness of surrounding tissue, enhancement of firmness to reduce slackening of the skin, and minimization of inflammation to prevent tissue damage DHEA is a natural prohormone produced by the body as a precursor to other hormones and also has direct anti-aging effects itself. As we age DHEA production decreases and this causes levels of other critical hormones to which it is a precursor to also decrease. Ultimately, this results in thinner skin that is more easily damaged and less elastic. Several studies have shown that DHEA is easily absorbed topically and has direct implications for skin thickening, which is critical not only for elasticity around the eye area but also decreases dark circles by providing a more opaque barrier between the skin’s visible surface and the underlying capillary network. The term “neuropeptides” describes specific peptide compounds that have been shown to have an effect on neurotransmitters in the skin (one that typically translates to a “relaxing” effect on wrinkles). While only wrinkle-relaxing injections can actually paralyze the underlying muscles of the face that affect facial expressions, there are actually subtle tensing contractions that go on in the skin itself. Often referred to as “micro-tension,” this is a more subtle yet still noticeable effect of contractions in the skin that show through as fine lines and deeper wrinkles. Bioflavonoids DHEA Prohormones Neuropeptides © 2009 XERIDIAN, LLC 3 Botanical Antioxidants & Anti-Inflammatory Therapy The extract of the Acai Berry contains several flavonoid-like compounds, including homoorientin, orientin, taxifolin, deoxyhexose, isovitexin, scoparin, proanthocyanidins as well as resveratrol. In evaluation of different acai varieties for their antioxidant capacity, the white species displayed little antioxidant activity against different oxygen radicals, whereas the purple variety (the one used in the ULTRA EYE SERUM) demonstrates excellent effectiveness against peroxyl radicals and peroxynitrite free radicals. Olive Leaf Extract contains oleuropein, hydroxytyrosol, oleocanthal, and several other polyphenols/flavonoids that give it highly powerful anti-microbial, antioxidant, and anti-acne properties. It has been shown to have an antioxidant capacity twice that of Green Tea Extract and 400% higher than Vitamin C. Green Tea Extract contains a broad spectrum of antioxidant polyphenols, including catechins, anthcyanins, and EGCG, as well as L-Theanine. It is one of the most widely used anti-aging ingredients in skincare formulas today with a long record of effectiveness against free radical damage in the skin. It additionally has clinical support as being effective against UV induced free radical damage and also acts as an anti-inflammatory agent. Red Tea contains antioxidant polyphenols (most notably Aspalathin) as well as a range of vitamins and minerals. It is distinct among other antioxidant rich tea ingredients because it comes from the African tea plant, Aspalathus linearis, while as Green & White Tea come from the Asian tea plant, Camellia sinensis. White Tea contains the highest levels of antioxidant catechins of any tea extract as well as more gallic acid and theobromine than Green Tea. Because it comes from the same plant as Green Tea (with the difference being that the leaves are picked when they are just buds), it furthers the antiinflammatory and antioxidant benefits of Green Tea when supplied in the same formula and supplied to the skin in the same application. The extract of Ginkgo Biloba contains high levels of flavonoids, terpenoids (ginkgolides and bilobalide) that provide antioxidant and anti-inflammatory benefits to the skin. Anti-Wrinkle & Anti-Sagging Peptides Polypeptides are amino acid proteins that have been specially utilized for the purpose of collagen stimulation when absorbed into the dermis. They are typically combined with natural factions of fatty acids to increase absorption (e.g. a palmitic acid from natural palm oil and an oligopeptide amino acid protein form Palmitoyl Oligopeptide, a novel compound for skin rejuvenation). The ULTRA EYE SERUM contains the widest spectrum of these peptides of any anti-aging skincare product on the market today, including Palmitoyl Tetrapeptide-7, Palmitoyl Oligopeptide, Palmitoyl Pentapeptide-3, Palmitoyl Tripeptide-5, Dipeptide-5, and Dipeptide-6. Copper Peptides are known by many names in the industry (e.g. Blue Copper, Copper Tripeptides, etc). These names refer to a special form of copper that is chelated to a natural amino acid protein to form a stable peptide (it must be used in this stable peptide form in skincare because copper alone is highly unstable and easily breaks down, especially in the presence of acidic conditions). Numerous clinical studies have demonstrated the abilities of topical copper solutions to accelerate wound healing, improve the appearance of scars, and stimulate collagen synthesis that ultimately yields tighter, smoother skin over time. Carnosine is often referred to as an anti-AGE protein because it is one of the single best tools in preventing and reversing the formation of Advanced Glycation End (AGE) Products in the skin, which are when proteins and sugars fuse together in a long process that results in increased degradation of the collagen network in the dermis (as well as elsewhere in the body). The ULTRA EYE SERUM is one of the very few products on the market to address this aspect of anti-aging by going beyond simple collagen stimulation to reverse wrinkle appearance and provide broad-spectrum support of the entire collagen network. Acai Berry Extract Olive Leaf Extract Green Tea Extract Red Rooibos Tea Extract White Tea Extract Ginkgo Biloba Extract Polypeptides GHK Copper Peptides L-Carnosine Peptides © 2009 XERIDIAN, LLC 4 Figure 1: Study Participant Age Range Figure 2: Study Participant Skin Type Range Figure 3: Fitzpatrick Skin Type Range There were a total of 15 participants in this study, composed of 10 females and 7 males. The age of these participants ranged from 25 to 69 with a median age of 47 (Figure 1). The participants were asked to stop the use of all other skincare products they may be using for one month prior to the study as well as during the study (except for products that were not “leave-on” such as cleansing or shower products). All participants were given the ULTRA EYE SERUM to use twice daily for a ten week period. 0% During the initial intake participants were asked to complete a self-evaluation questionnaire in which they assessed various characteristics of their own skin. Most notably this included a self-evaluation of their basic skin type: oily (excess sebum production resulting in greasy skin and/or glossy shine), combination (oily T-zone around the nose and/or forehead but dry skin elsewhere on the face), normal (hydrated but not oily skin), and dry (dull, flakey, and/or dehydrated skin that does not have enough sebum oil production to keep the skin moist). During the participant intake the tonality of the skin was assessed using a Fitzpatrick Skin Type Scale with one (I) representing very light pigmented skin, two (II) representing medium-light pigmented skin, three (III) representing medium skin, four (IV) representing medium-dark skin pigmentation, and (V) representing dark skin pigmentation. No one in this particular study had a Fitzpatrick Skin Type of VI, which is very dark pigmentation. 18% 18% 24% 40% 6% 12% 41% 12% 18% 3% 12% 23% 24% 29% I II III IV V < 29 50‐59 30‐39 60‐69 40‐49 >70 Oily Normal Combination Dry Study Methodology & Results To determine an absolute measurement of wrinkle depth a standard Skin-Visiometer® SV 600 was used, which evaluates the topography of the skin surface by light transmission of a thin blue dye silicone. This specially prepared silicone, mixed under a vacuum to avoid bubble formation, permeates even the smallest skin depths to form a micro-cast that is evaluated by a parallel light source and CMOS camera to quantitatively measure the heights and depths of the skin surface area as a negative. The statistical mean results of the study participants are presented in the graph below. 60% 50% 40% 30% 20% 10% 0% For the purposes of measuring dark circle coloration in the skin a standard Mexameter® MX 18 was used. The probe emits three specific wavelengths of light reflected by the skin in a receiver and the quantity of light absorbed by the skin can be calculated. To assess undereye skin discoloration skin using haemoglobin pigment as an indicator, specific wavelengths of light are used corresponding to the spectral absorption of peak haemoglobin at baseline then compared to final saturation at study end. The statistical mean results of the study participants are presented in the graph below. 40% 30% 20% 10% 0% 55% 36% 39% 31% 45% 25% 0% 0% Day 0 (Baseline) Day 35 Day 70 Average Percentage Improvement In Deep Wrinkle Depth As Measured With Skin‐Visiometer® SV 600 Average Percentage Improvement In Fine Line Depth As Measured With Skin‐Visiometer® SV 600 0% Day 0 (Baseline) Day 35 Day 70 Average Percentage Improvement In Dark Circles As Measured With Mexameter® MX 18 © 2009 XERIDIAN, LLC 5 BEFORE: This participant has moderate “dark circle” development under the eyes from thin peri-orbital skin as well as capillary damage that causes hemoglobin and iron to leak from blood vessels. AFTER: After ten weeks of ULTRA EYE SERUM application the dark circles have significantly diminished and there has been some softening of the fine lines that were beginning to form under her eyes. BEFORE: A side view of the same participant better demonstrates some of the fine lines that were beginning to form under the eyes as well as the dark circles and other minor discolorations. AFTER: The darkness and discoloration under the eyes has noticeably diminished and the fine lines beginning to form under the eyes have softened. © 2009 XERIDIAN, LLC 6 BEFORE: This study participant has moderate darkness under the eyes accompanied by minor discoloration. He also has a superficial abrasion that has been slow to heal. AFTER: The darkness and discoloration under this study participant’s eyes has noticeably diminished and the texture of his skin has become more uniform. The small abrasion under his eye has healed perfectly with no scarring and the light amount of hyperpigmentation he had has reduced in visibility. © 2009 XERIDIAN, LLC 7 BEFORE: This study participant has deep lateral wrinkles (“crow’s feet”) at the sides of the eyes and fine lines that surround the peri-orbital skin region. She also has mild dark circle discoloration in the undereye area. [Note: this participant has permanent makeup (tattooing of pigment to give the appearance of makeup wear even when no makeup has been applied) that accounts for some of the eyelid pigment, which is consistent in both the before and after pictures] AFTER: After ten weeks the deep lateral wrinkles at the sides of the eyes have dramatically decreased in depth and length. The fine lines that pervaded the peri-orbital skin have softened considerably. The moderate dark circles have lightened and the general tone of the skin is more even. © 2009 XERIDIAN, LLC
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