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CORE SCIENCE
 
 
 


Nerium SkinCare, Inc.® has developed the "first of its class" topical natural skin care cosmetic products based on an entirely new extraction process NBio-PL² ™ resulting in a new ingredient providing the best of the Nerium oleander plant and Aloe Vera properties. We want to share what we've learned through our development and testing of these new skin care products. Research to date has shown these natural products are safe and, in terms of effectiveness, consumers have confirmed the products works better for them than what they have found previously in the marketplace.

Nerium SkinCare's products are founded on the commitment to further develop this new ingredient technology, the core science, and provides for the continuing research of the Nerium oleander plant and other natural ingredients. This research and new ingredient technology has provided Nerium SkinCare with the opportunity and ability to formulate and develop for the consumer a unique, innovative, quality based  ever expanding series of natural skin care products. Initial product development has focused on cosmetic applications of NAE-8® for topical use. (See NeriumAD® topical age-defying cosmetic products.)

The development of this new ingredient breakthrough and it’s extraction-reaction technology has provided for a new patented process NBio-PL² ™ to extract from a botanical biomass and the creation of new active ingredients in a way that preserves their unique and beneficial properties. Specifically, this ingredient development process incorporates pure liquid Aloe Vera to extract-react with the unique Nerium oleander plant components in a way that creates the unique ingredient possessing the beneficial properties of both plants (this process is without any additional solvents). This has allowed Nerium SkinCare to create, formulate and develop the "first of its class" skin care products for topical applications utilizing NAE-8® (Nerium Aloe Ingredient).


Historical Use - Nerium oleander and Aloe Vera plants

Historical use of the Nerium oleander plant has been reported in ancient texts and folklore for more than 1500 years. The Nerium oleander plant has been used traditionally as folk remedies for a wide variety of conditions. Within the past decade there has been a substantial increase in the number of studies reported in peer-reviewed science journals that deal with Nerium oleander and its properties.


The Aloe Vera plant has also been well known for centuries for its properties; the raw plant and commercial preparations can be used. There are a vast array of products on the market containing Aloe Vera used in topical dressings, drinks, and skin care applications. .

Today Nerium SkinCare has learned how to create a new ingredient through a patented process that is able to combine some of the unique properties/molecules of both plants.


Product Formulation and Mfg.

Nerium SkinCare is dedicated to offering solutions that are based on scientific research and actual customer use experience. Products offered to the consumer will continue to be founded on continuing research at leading medical institutions using the latest scientific methods and technology. Products are nature based and scientifically developed and Nerium SkinCare oversees the quality control process from seed to finished product.

Nerium SkinCare's product formulation and production starts with the science developed from the USA-based environmentally responsible and earth-friendly farming operations, where fields of naturally grown Nerium oleander plants provide the raw material for Nerium SkinCare's botanical NAE-8® ingredient. Nerium SkinCare has over a decade of experience commercially growing the Nerium oleander plant to provide a renewable and dedicated source of biomass. Farming operations are considered all natural to meet the biomass standards required for biotechnology research and product formulation (without pesticides, etc.).

Product formulation has focused on the key NAE-8 ® ingredient and can be enhanced with fragrance, coloration, strength/potency, absorption/anti-absorption components, moisturizing components and any additional ingredients for target applications/markets.  GMP manufacturing facilities provide for product production.  Dr. Robert Newman's initial characterization and pharmacology research of the major biochemical and biological properties of Nerium oleander has served as the basis for quality control for the production of the Nerium Ingredients and associated products. Production yield, product stability testing, standardization, and clinical safety trials are ongoing, providing additional data for future regulatory requirements. The experience and ability to formulate and add additional ingredients to the multiple products required for Nerium SkinCare's success is in place.


 

NAE-8® Safety and Clinical Testing

Research for NAE-8® safety and clinical application was initiated with ST&T Research (Science, Toxicology & Technology). ST&T Research is comprised of a group of prominent scientist, including M.D. and Ph.D. pharmacologists/toxicologist and research product development oriented physicians, scientist, and regulatory compliance specialists which include a legal team specializing in US FDA/FTC/Customs regulations. ST&T Research provides product development, product compliance, regulatory compliance, clinical testing, and information and data for safety and efficacy.

Dr. Robert A. Newman as scientific advisor to Nerium SkinCare provided assistance to ST&T. With data from previous research studies, clinical trial experience, and utilization of validated analytical methods, Dr. Newman assisted with NAE-8® safety support and analysist.

ST&T Research initiated clinical human studies (4) for safety with topical application of a base cream which included the NAE-8® ingredient. The NBI topical test article application was first applied as a spot treatment, then to increasingly larger areas of skin application with each new clinical study to evaluate absorption. The studies included participants that exhibited various skin conditions to assist in the evaluation of the absorption of the NBI topical test article with different skin conditions. A variety of compromised/damaged/broken skin conditions were presented as the application coverage area increased (age spots, actinic keratosis, acne vulgaris, sunburn, and fever blisters/cold sores). Two (2) of these clinical studies included a comparison to well-known OTC products currently available to consumers.

Each study's primary end-point was to evaluate the NBI test articles for safety/toxicity, a) Determine if the Nerium oleander metabolites were being absorbed through the skin, b) If so, how much, c) If there was any noticeable blood pressure or heart rate changes, and d) If there were changes in blood chemistry or organ system functions. In addition, subjects were observed for inflammation, rash, or tenderness possibly related to the cream application.

ST&T Research utilized blood chemistry and CBC analysis whereby a comparison was made of the participant's initial baseline results with additional measurements taken throughout the study. As an example, participant blood samples were taken on day one (1) (one hour after cream application), day seven (7), day fifteen (15), and on day thirty (30) of NAE-8® use to test for absorption and accumulation.

Analysis was non-eventful. The analysis showed all subjects within normal ranges, there were no detectable metabolites absorbed systemically and no adverse reactions noted. With regard to efficacy, ST&T was surprised to find there were a statistically significant number of subjects reporting positive results since the NBI test articles contained no "additives or cleansing compounds" like the OTC products.

Investigators: Science, Toxicology & Technology and its physicians / health care practitioners.
Sponsor: Nerium Biotechnology Inc. (NBI) / Nerium SkinCare, Inc.


Product Clinical Testing, with Safety Components

Upon the completion of the initial NAE-8® safety trials, continuing research and newly formulated products (NeriumAD Night Cream, NeriumAD Day Cream, etc.) have proceeded to clinical trials and the consumer market.

Anti-aging skin creams are abundant in today's cosmetic marketplace. New ingredients that may provide additional efficacy are sought to improve existing products. The NeriumAD® formulation is specifically designed for this market and provides two (2) such ingredients, NAE-8® and a proprietary peptide matrix.

Clinical product testing was provided by ST&T Research utilizing technology from the semi-conductor industry, now transferred to the skin care industry. Test subject outcomes included subjective and objective evaluation of changes in appearance of fine lines and wrinkles, discoloration, and uneven skin texture, using an advanced R&D model fluorescence spectroscopy skin analyzer. The clinical results of these trials have continued to demonstrate safety and the effective use of these products as a topical application for the consumer.

Investigators: Science, Toxicology & Technology and its physicians / health care practitioners.
Sponsor: Nerium SkinCare, Inc.