Journal of Clinical and Aesthetic Dermatology

DEC 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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27 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY December 2017 • Volume 10 • Number 12 O R I G I N A L R E S E A R C H A A primary goal in the treatment of the skin is the accurate and efficient delivery of therapeutic agents. Liposomes have been extensively investigated for this purpose. A liposome is a vesicle with one or more double layers of phospholipid and cholesterol that might or might not enclose a large aqueous space. The main advantage of liposomes is that they can encapsulate and sometimes deliver both hydrophobic and hydrophilic drugs to a therapeutic target. This is possible because the lipid bilayer of the liposome can include anionic, cationic, or neutral phospholipids and can entrap hydrophobic compounds, while the large aqueous core can encapsulate hydrophilic drugs. 1 A Novasome™ is a unique type of liposome. Unlike most liposomes, the liposomes in Novasomes have 2 to 7 bilayer membranes surrounding a large central "cargo" area not present in most other liposomes (Figure 1). Most liposomes consist of concentric membranes with a solid core, much like a large onion. Figure 2 shows the membrane layer cutaway of a Novasome to reveal the innermost membrane that surrounds the inner chamber. The liposomes in Novasomes have a hydrophobic tail group and a hydrophilic head group. Up to 80 to 85 percent of the Novasome core can be loaded with a medication from which the medication's active ingredients can be released in a predictable manner. Encapsulated drugs travel through channels in the bilayer, making sustained, controlled release of active ingredients possible. 2 Novasome microvesicles are stable, with a pH ranging from 2 to 13 and a temperature ranging from that of liquid nitrogen to higher than 100°C. They can therefore be used in a wide variety of applications. 3 Since Novasomes can be made with a positive, negative, or neutral charge on the surface, they can adhere to specific sites on skin and hair shafts and thus can be used in cosmetic formulations. 4 For example, if the charge of the Novasome is positive, then it can combine with skin that has a negative charge. 2 DermaTriPlex™ is a globally patented technology platform comprising Novasome —a patented amphiphile and transdermal delivery platform designed for specific ingredients with performance characteristics that can be changed through the modification of the amphiphilic portion for a specific molecule; TruCollagen® (USV Private Ltd., Mumbai, India)—the largest segment of synthetically engineered natural collagen in the world (to the author's knowledge); and and Teosyal Resilient Hyaluronic Acid® (RHA) The DermaTriPlex technology platform is supported by 20 synergistic, scientifically proven, anti-aging ingredients at concentrations known to be effective. The purpose of this study was to evaluate the efficacy of five topical test products intended to reduce the appearance of lines and wrinkles, A B S T R A C T OBJECTIVE: The purpose of this study was to evaluate the efficacy of five topical test products intended to reduce the appearance of lines and wrinkles, increase skin moisturization, and reduce transepidermal water loss. DESIGN: Two studies—a controlled clinical trial for each individual test product and an experience trial involving more than 200 patients using a strategic combination of products—were done. Test products included a day facial cream, a night facial cream, an eye cream, a day lip cream, and a night lip cream. SETTING: The setting for the first study was AMA Laboratories (New York, New York)and 19 physician practices for the second. PARTICIPANTS: For the first study, participants were recruited via advertisements, phone solicitation, or electronic media. Patients of the second study (N=222) were from 19 physician practices. MEASUREMENTS: For the first study, efficacies of the facial and eye creams were determined by measuring the surface evaluation of living skin, transepidermal water loss, and electroconductivity. Efficacy of the lip creams was evaluated by measuring surface evaluation of living skin and electroconductivity. These evaluation parameters were measured at the test sites prior to initial application of test product,15 minutes after the initial application, and at seven, 14, 28, and 56 days of test product use. For the second study, each subject completed an assessment of the topical product(s) effects after four weeks of use. RESULTS: With each of the five topical test products, an improvement in surface evaluation of living skin became apparent within 15 minutes of initial application of test products and continued for at least 56 days of regular use. Electroconductivity data showed that each product dramatically increased the moisture content in the skin almost immediately after application and for at least 56 days. Improvement in transepidermal water loss was nearly immediate and continued over time with the day and night facial creams and eye cream. For the experience trial, a significant majority of subjects achieved one or more endpoints within 30 days or less. CONCLUSION: The facial, eye, and lip creams are effective anti-aging products that reduce the appearance of both fine and coarse lines and wrinkles, dramatically increase the moisturization of the skin, and, in the case of the face and eye products, reduces transepidermal water loss. These changes last for at least 56 days without significant adverse effects. KEYWORDS: Electroconductivity, fine lines, hydration, lip cream, transepidermal water loss, wrinkles Efficacy and Safety of an Anti-aging Technology for the Treatment of Facial Wrinkles and Skin Moisturization by MARK A. PINSKY, MD, PA Dr. Pinsky is the founder and a plastic surgeon at Plastic Surgery Innovations, LLC in Palm Beach Gardens, Florida. J Clin Aesthet Dermatol. 2017;10(12):27–35 FUNDING: No funding was received for this study. DISCLOSURES: Dr. Pinsky is a minority stock holder in Alphaeon Corporation. CORRESPONDENCE: Mark A. Pinsky, MD, PA; Email: mpinsky@pinskymd.com

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