ULTRA SERUM™ Clinical Study XERIDIAN® CLINICAL SKINCARE® 2 General Discussion The Ultra Serum™ is a face and neck product that utilizes a broad range of anti-aging polypeptides to dramatically influence the synthesis of new collagen fibers in the skin and correct the appearance of lines, wrinkles, and sagging. This collagen-promoting action is furthered by L-Carnosine amino-peptides, which prevent the formation of Advanced Glycation End (AGE) products that are the result of fusions between proteins and sugars. Algae Phytopeptides in this serum work to tighten epidermal structures and give an immediately perceivable lift to sagging skin. For antioxidant and anti-inflammatory support, this formula contains extracts of Olive Leaf, Acai Berry, Green Tea, Red Tea, White Tea, Ginkgo Biloba, and other phytonutrient-rich botanicals that fight free radical damage and calm inflammation. o Anti-Wrinkle & Anti-Sagging – 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. Anti-AGE – This formula 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. Immediate Perceivable Tightening – The Algae Phytopeptides in this formula produce a noticeably tighter appearance to facial structures within minutes of application that compliments the long-term firming results achieved by the amino-peptides. Defense Against Free Radicals – Phytonutrients from key botanical extracts saturate the skin in antioxidants that defend against free radical damage. In this formula there are 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. Anti-Inflammatory – Active botanical extracts work to sooth inflammation that is caused by oxidative stress on cellular structures. As inflammation decreases the face takes on a more sculpted, youthful contour and skin tone evens out as redness from irritation calms. o o o o Formula Active Mechanisms 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 displays little antioxidant activity against different oxygen radicals, whereas the purple variety (the one used in the ULTRA 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 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 anti-inflammatory 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. Acai Berry Extract Olive Leaf Extract Green Tea Extract Red Rooibos Tea Extract White Tea Extract Ginkgo Biloba Extract © 2009 XERIDIAN, LLC 3 Algae Phytopeptides Anti-Wrinkle & Anti-Sagging Peptides Algae Phytopeptides are derived from a special purification process of a proprietary algae variety that provide both immediate and long-term skin tightening effects in the epidermis. This extract also has the added benefit of supplying several minerals, nutrients, and emollients. 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 SERUM contains the widest spectrum of these peptides of any antiaging 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 SERUM is one of the very few products on the market to address this aspect of antiaging by going beyond simple collagen stimulation to reverse wrinkle appearance and provide broad-spectrum support of the entire collagen network. 6% 12% 12% 18% Polypeptides GHK Copper Peptides L-Carnosine Peptides Study Participant Demographics There were a total of 15 participants in this study, composed of 10 females and 5 males. The age of these participants ranged from 27 to 72 with a median age of 50 (Figure 1). The participants were asked to stop the use of all other skincare products they may have been using for one month prior to the study as well as during the study (except for products that were not “leave-on” such as their usual cleansing or shower products). All participants were given the ULTRA SERUM to use twice daily for a ten week period. During the initial intake the participants of this study were asked to complete a self-evaluation questionnaire in which they assessed various characteristics of their own skin (Figure 2). Most notably this included a self-evaluation of their basic skin type: oily (characterized by excess sebum production that results in acne, greasy skin, and/or glossy shine), combination (characterized by an oily T-zone around the nose and/or forehead but dry skin elsewhere on the face), normal (characterized by the proper balance of oil production to keep the skin plump, hydrated, and moist but not enough to appear greasy, shiny, or for significant acne development), and dry (characterized by dull, flakey, and/or dehydrated skin that does not have enough sebum oil production to keep the skin moist). Also during 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. (Figure 3) < 29 30‐39 40‐49 50‐59 28% 24% Figure 1: Study Participant Age Range 60‐69 >70 20% 33% Oily Combination Normal 20% Dry 27% Figure 2: Study Participant Skin Type Range 7% 13% 27% I II III 20% 33% Figure 3: Fitzpatrick Skin Type Range IV V © 2009 XERIDIAN, LLC 4 Study Results To determine changes in skin elasticity (including tightness and skin sagging) a Cutometer® MPA 580 was utilized. The measuring principal is based on the use of negative pressure to draw a small amount of skin into the device aperture where the device calculates the depth of penetration using a non-contact optical measuring system. The resistance of the skin to the negative pressure of the probe displays a quantitative calculation of firmness and its ability to return to original position within a given time frame allows for a quantitative calculation of elasticity. The statistical mean results of the study participants are presented in the graph below. 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. 50% 50% 40% 30% 20% 10% 0% 41% 40% Average Percentage Improvement In Skin Elasticity Of Subjects As Measured With Cutometer® MPA 580 27% 30% 20% 10% 0% 35% 27% 46% 39% 0% Day 0 (Baseline) Day 35 Day 70 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 To evaluate the topography of the skin and assess subtle changes beyond the scope of the naked eye a UV light evaluation of skin topography was used in line with the Visioscan® VC 98 industry standard protocols of evaluation. This type of skin assessment has implications in the general improvement of the skin (improvements in pore size, texture, roughness, and micro-tension) and provides subsequent validation of other test results. The statistical mean results of the study participants are presented in the graph below. 40% 35% 30% 25% 20% 15% 10% 5% 0% For the purposes of measuring inflammation/irritation 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 chronic inflammation in the skin using erythema redness as an indicator, specific wavelengths of light are used corresponding to the spectral absorption of peak haemoglobin that avoid other color influences such a bilirubin. The statistical mean results of the study participants are presented in the graph below. 35% 30% 25% 20% 15% 10% 5% 0% 36% 33% 25% 25% 18% Average Percentage Improvement In Roughness Average Percentage Improvement In General Skin Topography 21% Average Percentage Improvement In Redness As Measured With Mexameter® MX 18 0%0% Day 0 (Baseline) Day 35 Day 70 0% Day 0 (Baseline) Day 35 Day 70 © 2009 XERIDIAN, LLC 5 Before & After of Nasolabial & Mandible/Jowl Facial Skin Regions BEFORE: This participant has a minor amount of scarring and “cratering” from a previous acne condition years before, as well as small areas of discoloration on the cheeks. Most noticeable is the skin crease of the nasolabial fold region (from the side of the nostril to the side of the lips) caused by a weakened collagen network that is increasingly less resilient to repeated facial movements such as laughing and smiling. AFTER: The subtle scarring left from previous acne lesions has greatly diminished to being almost unnoticeable and the evenness of his skin tone has significantly improved (especially the redness in the cheeks). The most obvious improvement is around the nasolabial fold skin region in which the crease that was very pronounced has smoothed out considerably. © 2009 XERIDIAN, LLC 6 Before & After of Cranial Skin Region BEFORE: This study participant has noticeably enlarged pores throughout his forehead as well as some minor hyperpigmentation discoloration around the sides. Most apparent are the two lateral forehead wrinkles that have formed as creases from repeated expressions coupled with collagen degradation over time. AFTER: After ten weeks of twice daily application of the ULTRA SERUM this participant’s pores have greatly tightened with virtually no blackheads (oxidized sebum oils that clog the visible surface of the pores). The hyperpigmentation on both sides has significantly diminished and the overall skin tone has evened out. Most noticeably, the two lateral wrinkles that were once pronounced have become just barely visible. © 2009 XERIDIAN, LLC 7 Before & After of Mid & Lower Face Skin Regions BEFORE: This study participant has numerous fine lines around the mouth as well as some nasolabial fold creasing that parallels the nostrils down to the sides of the mouth. She also has minor inflammation in the cheeks and chin as well as a small number of visibly broken capillaries in the skin. AFTER: The fine lines and wrinkles around the eyes and mouth have noticeably diminished to create a much younger look to the skin around the lips. The puffiness and irritation in her cheeks has greatly reduced and the nasolabial fold region appears tighter and more lifted. The redness in her cheeks has also greatly diminished. Her pores are much softer and the overall tone of her face has evened out. © 2009 XERIDIAN, LLC 8 UV Light Analysis of the Mid-Face Skin Region BEFORE: This is the same participant from the previous face analysis shown under a UV Light Lamp used by dermatologists to assess underlying skin damage by increasing the contrast of skin imperfections. Due to the special light source the resolution is slightly less focused than if taken under a fuller light spectrum, but several details are still apparent. This participant has some underlying pigmentation on the checks and nose as well as many smaller areas of dryness (as revealed by the small white flakes that look like static). Also present is subtle irritation (shown here as violet-red blotchiness) throughout the face. AFTER: After ten weeks this participant had a substantial clarification of underlying irritation throughout her face as well as an evening out of general facial tone. This analysis shows a significant improvement in the underlying pigmentation of her skin that was only visible under this special UV light. Interestingly, though the ULTRA SERUM is not meant as a primary moisturizer there seems to be a dramatic improvement in hydration, as noted by the absence of dry skin “static” present in the before picture. © 2009 XERIDIAN, LLC