WHAT IS ACTIFIRM ULTRA? WHAT IS IT FOR? WHAT DOES IT DO? HOW IS IT DIFFERENT? HOW DO I USE IT?

Transcription

1 TM CTFA/INCI Name: Dipropylene Glycol Centella Asiatica Extract Echinacea Angustifolia Extract Rosmarinus Officinalis (Rosemary) Leaf Extract SD Alcohol 40-B CAS Numbers: , , , , , EINECS/ELINCS Numbers: , , , WHAT IS ACTIFIRM ULTRA? Actifi rm Ultra is a blend of three complementary natural extracts designed to rebuild and protect the fragile skin architecture, from the inside out. Standardized extracts from Echinacea Angustifolia (Ursolic Acid), Centella Asiatica (Asiatic Acid), and Rosmarinus Offi cinialis (Rosmarinic Acid), are incorporated into an advanced delivery system. WHAT DOES IT DO? At the molecular level, Actifi rm Ultra up-regulates the production of elastin, procollagen and vimentin. Each of these proteins are involved in dermal matrix stability, and decrease, or are damaged during aging. In addition, the synthesis of dermal MMPs (destructive enzymes which reduce dermal integrity) are down-regulated (decreased). Actifi rm Ultra also reduces dermal protein glycation due to UV and any infl ammatory reaction. These molecular changes result in structural and functional changes in both the epidermis and dermis. The visible results of these changes are improved skin fi rmness, reduced skin sagging, a reduction of both superfi cial and deeper wrinkles, and overall, a younger looking skin. WHAT IS IT FOR? Actifi rm Ultra should be used in products designed to reduce the visible signs of aging on the face (especially the eye area), the hands, and the body. Actifi rm Ultra is non-irritating, and is not an exfoliant. It can be combined with other anti-aging treatments such as exfoliants, retinoids, peptides and physical or mechanical dermatological treatments. HOW IS IT DIFFERENT? Actifi rm Ultra is a combination of three complementary natural products, each with a different activity. With continued use, Actifi rm Ultra rebuilds and protects in a non-irritating neutral manner, and can be used on all skin types. HOW DO I USE IT? Actifi rm Ultra has been developed to be used at 2% - 5%, in daily use products. Actifi rm Ultra should be added to the fi nal stage of production at 60 C or less. 1 - Actifirm Ultra

2 INTRODUCTION blend of three standardized herbal extracts designed to alleviate the visible signs of aging in human skin. Actifi rm A Ultra consists of Asiatic Acid from Centella Asiatica, triterpenoids from Rosemary Offi cianalis, and polyphenolics from Echinacea Angustifolia. Clinical evaluation of the blend has shown that topical application of the extracts at a 5% addition to a formula, has unique properties including: Reduction of fi ne lines and wrinkles Increase in the density and thickness of the skin Increase in the fi rmness of skin A decrease in the sagging of skin FIRMING: As we age, the total collagen content of the skin decreases, leading to a potential decrease in fi rmness. The stimulation of collagen production is necessary in aged individuals in order to maintain fi rm and healthy skin. Asiatic Acid, extracted from Gotu Kola (Centella Asiatica), has the ability to stimulate dermal fi broblasts and increase collagen synthesis (in vitro). HYDRATION: The polysaccharide content of the dermis is responsible for the hydration of the skin. As we age, we experience a reduction of these structures in the skin a reduction of the water-binding capacity of the skin. This may lead to the appearance of lines and wrinkles that are otherwise concealed by healthy, plump skin. The polyphenolic fractions of Echinacea Angustifolia have the ability to effectively inhibit Hyaluronidase, the enzyme responsible for the degradation of hyaluronic acid. ANTI-SAGGING: Elastin, the structural protein which allows our skin to stretch, also deteriorates as we age, primarily due to the long term effect of infl ammation. Infl ammatory responses cause the release of degradative enzymes including Human Leukocyte Elastase (HLE). This enzyme not only destroys the elastin content of the dermis, it can be responsible for the degradation of other valued components as well. Loss of elastin may lead to sagging of the skin. The triterpenoid fractions of Rosemary (Rosmarinus Offi cinalis) have the ability to effectively inhibit HLE (in vitro). 2 - Actifirm Ultra

3 TM TM CLINICAL RESULTS SUMMARY: In clinical studies, the ability of a standardized blend of the three aforementioned extracts, Actifi rm Ultra, was demonstrated to signifi cantly modify the cosmetic properties of the skin. More importantly, in vivo tests demonstrated that Actifi rm Ultra can decrease the appearance of fi ne lines and wrinkles, increase both the fi rmness and density of the skin, and also exhibit a clinical improvement to the degree of skin sagging with continuous use. These results suggest that the enriched blend of extracts have signifi cant possibilities as functional cosmetic ingredients. IN VITRO TESTING & RESULTS I. INTEGRAL AND SUPERFICIAL SKIN FIRMNESS SUPERFICIAL SKIN FIRMNESS Table 1 presents results of both superfi cial skin fi rmness and integral skin fi rmness measurements, on 10 subjects treated with the test product described above. Results indicated show that, with 5% Actifi rm Ultra, a slight increase in superfi cial skin fi rmness was observed at 2 weeks (14%), a greater result was observed after 4 weeks (21%), and a still greater overall increase at 8 weeks of testing (24%). No effects whatsoever were observed with the control carbopol vehicle. INTEGRAL SKIN FIRMNESS Using the integral method of measuring skin fi rmness, we observed no changes in fi rmness induced by the control treatments. However, with the enriched extract (Actifi rm Ultra), we observed an increase in integral skin fi rmness of 33% after 8 weeks (Table 1). Smaller increases were observed after 2 and 4 weeks, which is consistent with these measurements refl ecting changes in the underlying layers of the skin TABLE 1 - SKIN FIRMNESS % INCREASE SUPERFICIAL SKIN FIRMNESS INTEGRAL SKIN FIRMNESS 0 2weeks 4 weeks 8 weeks 3 - Actifirm Ultra

4 II. SKIN THICKNESS AND SKIN DENSITY Skin thickness and density measurements were made after treatments with test materials. Results indicated that no increases in thickness, or changes in density were observed, even after 8 weeks treatment with the control formula. However, with the enriched extract (Actifi rm Ultra), we observed signifi cant changes in skin thickness and density after 4 & 8 weeks, (Table 2). % INCREASE TABLE 2 - SKIN THICKNESS & DENSITY SKIN THICKNESS SKIN DENSITY 0 2weeks 4 weeks 8 weeks II. LINES AND WRINKLES TABLE 3 - SUPERFICIAL FACIAL LINES weeks weeks weeks 0 10 Wrinkles were graded (based upon an in-house developed scale), on each side of the face of test participants before and after 2, 4 and 8 weeks of product usage. Results in Table 3 demonstrate Actifi rm Ultra improved the lines and wrinkles after 2 weeks, and more so after 4 and 8 weeks. No effects were observed with the control formula. % DECREASE Actifirm Ultra

5 TM TM II. SKIN SAGGING Skin sagging was measured on the face of test participants before and after 2, 4 and 8 weeks of product usage. Results on Table 4 demonstrate that the extract improved the skin sagging moderately after 4 weeks (>11%), and provided signifi cant increases after 8 weeks (>18%). No effects were observed with the control formula. % DECREASE IN SAGGING TABLE 4 - SKIN SAGGING weeks weeks weeks DISCUSSION The results indicate that the test material supplied by Active Organics has interesting possibilities as a useful cosmetic ingredient. Both superfi cial and integral skin fi rmness were increased substantially over the 8-week test period. It is likely, based upon the proposed mechanism of action, that these results would increase even more so after 12 weeks of continued usage. Ultrasound analysis demonstrated that skin thickness and density increased after 4 and 8 weeks; this is also consistent with a test material increasing fi broblast metabolism and collagen synthesis. Clinical testing also demonstrated that the enriched extract was effective at reducing lines and wrinkles on test panelists. Finally, results show a signifi cant decrease in the sagging of skin. 5 - Actifirm Ultra

6 EXPERIMENTAL DESIGN: I. INTEGRAL AND SUPERFICIAL SKIN FIRMNESS To measure fi rmness at deeper layers in the skin, the ballistometer as tested, was slightly modifi ed. A 5 gm weight was attached to the Plexiglas probe to be dropped upon the skin surface. With a greater weight the probe makes a greater indentation into the skin structure, and encounters the underlying layers of the skin. A rebound occurs as the skin resists deformation; however, the rebound is to less of a degree. Although a number of data analyses are possible, the most appropriate analysis to measure fi rmness of the underlying skin, is to measure the degree of indentation with a fi xed load. In this sense the ballistometer behaves similarly to the Indentometer. Using this analysis, we observed on a group of year old subjects, an indentometry equivalent to 0.65 mm. On the same site with a group of year olds, the degree of indentation was 1.34 mm, an increase of about 100%. Moreover, we observed that with product treatment, while the H1/H2 ratio as described above often changes within 2-5 days after treatment, with similar products, we observed no changes in indentometry on the cheek until after 2 or 4 weeks. II. SKIN THICKNESS AND SKIN DENSITY A Dermascan C Ultrasound available from Cortex Technology, Denmark, was used to measure skin fi rmness in these studies. The unit has a resolution of 20MHz, and the A scan was used. With this device, differences between the epidermis, dermis and subcutaneous fat layers can be measured. In addition to measuring the thickness of each layer of skin, in the zoom mode, images were imported into a PC based image analysis system, and relative tissue density was measured. Since fl uid does not produce an ultrasound image, relative tissue density was determined by calculating the density of the ultrasound signal in each of the tissue layers of interest. If an increase in dermal tissue thickness is observed, this can be due to a swelling of the tissue (infl ammation or edema), or a stimulation of new protein synthesis. A dermal increase in thickness with a decreased density would not be positive, and refl ect an infl ammatory process. An increase in thickness, with maintained or increased density would refl ect a stimulation of dermal metabolism, a positive effect. 6 - Actifirm Ultra

7 TM TM III. LINES AND WRINKLES We clinically assessed for the visible appearance of lines and wrinkles via the method of Packman described in [Packman, E., and Gans, E.H. Topical moisturizers: quantifi cation of the effect on superfi cial facial lines. Soc. Cos. Chem. 29, (1992)]. The scale is based upon determining weighted numbers for the severity and number of lines and wrinkles. The face is divided into a number (6) of sectors for analysis. We followed the method as described exactly except for subject equilibration, which follows our standards methods as described in TEWL. In addition, all assessments were done blinded and by two investigators or technicians. Values obtained were averaged as a single reading. IV. SKIN SAGGING As skin ages, a breakdown in collagen and connective tissue results in a change in the bio-mechanical properties of the skin. A variety of bioengineering techniques can be used to assess such changes including, indentometry, cutometry or ballistometry. Each of these methods in their unique way assesses properties such as fi rmness, elasticity, etc. While these are useful methods and can document product effects, the one limitation of such techniques is that they are not consumer relatable, and cannot be directly correlated with a visual effect on the skin. We have developed a method to assess changes in skin properties related to fi rmness, by measuring the sagging or deformation of facial skin due to different forces. In our method subjects are fi rst placed in a reclining position, with their face directed towards the ceiling. A number of marks are placed on the cheek and lateral chin area, and the distance is precisely measured from a fi xed feature on the face, such as the center of the eye when focused directly forward. Subjects are then either inclined into a normal upright position, or further declinated so their body axis is 45 degrees in orientation, with respect to a horizontal body axis. The change in distance from the fi xed reference point is re-measured. A sagging quotient for each point marked on the face is determined as follows: Sagging quotient (SQ) = (d1)2 + (d2)2. The SQ values obtained before treatment are compared with those obtained after treatment to determine the signifi cance of product effects. Using this analysis we have obtained the following data on facial skin from various age groups of subjects. 7 - Actifirm Ultra

8 The information presented applies to cosmetic product use and is intended for information only. It is the responsibility of the user of this ingredient to test finished product for safety and claim substantiation purposes. Active Organics, Inc Yates Street, Lewisville, Texas USA Tel: Fax: Website: activeorganics.com Actifirm Ultra is a trademark of Active Organics, Inc., a Lubrizol Company. Actifirm Ultra NPI , 2014 by Active Organics, Inc. 8 - Actifirm Ultra