Efficacy of a Biorevitalizing-Filler Solution on All Skin Aspects: 10 Years Approach through <i>in Vitro</i>Studies and Clinical Trials

Introduction: Skin aging is the result of many cellular dysfunctions over time particularly the fibroblasts and the keratinocytes. These dysfunctions could be decelerated by the preventive effects of some skin treatments such as Intradermal injections. NCTF 135HA has a polycomponent formulation designed to improve the efficacy of non-cross linked hyaluronic acid (as a micro-filler) on fibroblasts function. Although NCTF 135HA has been used by aesthetic practitioners since 20 years, we have analyzed all in vitro, ex vivo and in vivo studies during past 10 years in order to summarized its anti-aging effect. Methods: In these series of studies, the known effects of HA have been evaluated with this boosted formula. Collagen I synthesis, antiglycation effect and contractile forces developed by fibroblasts were studied. Fibroblasts and keratinocytes proliferations were evaluated in monolayer cells culture. The filling effect thanks to NCTF 135HA injection was ex vivo performed by fringe projection and the protective effect of NCTF 135HA against solar irradiation was performed ex vivo to study proliferation rate, elastin and collagen expression. Two clinical trials were performed on women to evaluate the anti-aging effect of NCTF 135HA injection. Hydration, firmness, radiance, wrinkles size, pore size, thickness and density of the dermis were analyzed. Results: Collagen I, anti-AGE products, cell proliferation and contractile forces were significantly increased with NCTF 135HA in culture medium. Ex vivo studies showed that NCTF 135HA increased, cells proliferation rate, elastin and collagen production. In addition, the filling effect of the NCTF 135HA is significantly superior to placebo. The first clinical trial shows that NCTF 135HA injection significantly increased tonicity, hydration and radiance of the skin and significantly decreased wrinkle score. The second clinical trial demonstrated that NCTF 135HA injection significantly increased dermis density and thickness, skin homogeneity and skin radiance and significantly decreased pore size and wrinkle depth and volume. Conclusion: In vitro, ex vivo and in vivo studies showed that this minimally invasive technique could be used in order to improve the skin quality which could have a visual effect on preventing the aging signs.

Clinical Assessment of a Mesotherapy Formulation for Skin Rejuvenation in Healthy Volunteers

Mesotherapy is a mildly invasive procedure involving several subcutaneous drug injections, which are performed simultaneously. The concept is to inject a very small amount of active compounds (hyaluronic acid, vitamins, antioxidants, enzymes, humectants, …) and the aim is to stimulate the biosynthetic capacity of fibroblasts, increase collagen and elastin production and to give active essential molecules for a fibroblasts environment. Numerous studies suggest that the mesotherapy procedure improves skin hydration and mechanical properties;however, some results have not been statistically significant. In this study, we investigated an antiaging treatment as a complementary approach to a non-surgical rejuvenating procedure after 5 sessions of mesotherapy. Our main objective was to assess the improvement of face, neck and neckline skin quality, after intradermal microinjections of NCTF 135HA&reg. This mixture, manufactured by FILORGA Laboratories, includes a non-cross-linked hyaluronic acid, vitamins, antioxidants, mineral salts and enzymes. A statistically significant decrease in the depth of crow’s-feet wrinkles (43.3%) and in pore size (58.5%) was observed. Also, dermatological scores showed a significant decrease, and data suggest that skin tone was improved with a brighter tone. The injected mixture could then have an action on the skin pigmentation process with a photoprotective effect. Evolution of Dermis density was also investigated and an increase of dermal density and thickness were highlighted, showing an improvement of skin firmness with significant increases of dermis thickness (20%) and dermis density (24%), indicating a neocollagen activity.

Anti-Aging Efficacy of a New Alendronate-Pravastatin Cosmetic Combination: A Randomized Double Blind Comparative Study

Progeria is a rare genetic disease that causes accelerated aging and death in children at a mean age of 13.5 years. An?aminobisphosphonate-statin combination has been shown to reduce the toxicity of the mutated protein, progerin, in progeria patient cell cultures and in a mouse model of the disease. This combination is currently being tested in a European Therapeutic Trial for progeria in Marseille (ClinicalTrials.gov identifier NCT00731016). Progerin has been shown to be produced by skin cells during physiological aging. The objective of this study was to assess the efficiency of a new and original cosmetic formulation containing alendronate and pravastatin sodium salts, reduce crow’s feet wrinkles, and cheek hollow in a double blind, randomized and placebo controlled comparative study. Three cosmetic preparations were evaluated using Fast Optical in vivo Topometry of human Skin (FOITS): one containing sodium alendronate and sodium pravastatin, a placebo, and a commercial anti-aging product. Fifty-seven female and twenty-five male volunteers between 51 and 71-year-old were selected. Each subject tested two of the three products once a day, in the evening, by spreading each selected product on one side of the face. Skin micro-relief was analyzed at 0, 28, 56 and 84 days. Statistical analysis of 7 clinical qualitative (left or right side of face, gender, and 3 skin types) and 6 quantitative parameters (age, weight at each test time, wrinkle clinical grade at inclusion time) showed no statistical differences between the three tested products. In contrast, most of the 8 quantitative FOITS parameters describing skin micro-relief were statistically improved by the alendronate-pravastatin combination compared to the placebo or to the commercial anti-aging product. A cosmetic preparation containing alendronate and pravastatin sodium salts exhibited anti-aging effects by reducing crow’s feet wrinkles and restoring cheek volume.