Novel cosmeceutical product line sets a new bar in topical skincare

An innovative new line of cosmeceuticals (Nuvesse^MD, Nuvesse Skin Therapies) is being looked at as an exciting advance in the skincare market.

The prestige products incorporate ingredients with scientifically proven skin-enhancing properties and a proprietary transdermal delivery technology (Cellulatio) that is groundbreaking in its ability to actively transport the topically applied constituents into the epidermis without altering the integrity of the stratum corneum. In addition, the products are formulated with only Generally Regarded As Safe (GRAS) materials, and their effectiveness is backed by data from clinical trials.

David Richard, chief operating officer and co-founder of Nuvesse Skin Therapies, is the inventor of the proprietary delivery technology.

“Nuvesse grew out of a woundcare company (PolyRemedy) where we developed a proprietary dressing for healing chronic and refractory wounds,” he tells Dermatology Times. “Having identified an optimal group of constituents for enabling skin repair and an effective delivery system, it was intuitive to translate those discoveries to create an advanced line of topical skincare products for restoring skin to a healthier and more youthful condition.”

“We believe that our merging of science with the art of formulation has resulted in the creation of exceptional products for improving the skin,” Mr. Richards adds.

W. Philip Werschler, M.D., serves as Nuvesse medical director and was an investigator in their clinical trials. He notes that historically, treatments for improving the cosmetic appearance of the skin have been based on the principle of wounding to allow penetration of topically applied modalities through the disrupted skin and to stimulate restorative healing.

“This concept has been the foundation underlying the use of chemical peels, laser treatments or chemicals with minor irritant properties, such as retinoic acid, salicylic acid or alpha-hydroxy acids,” says Dr. Werschler, associate clinical professor of medicine/dermatology, University of Washington, Seattle. “However, the holy grail has been to find ways to deliver ingredients into the skin and stimulate healing processes without causing damage.

“With this novel translational technology emerging from the woundcare arena, we’ve satisfied the quest for optimizing skin health and function without first breaking it down.”

Next: The transdermal delivery platform

Delivery system basics

The transdermal delivery platform is based on the creation of biocompatible polymeric micelle constructs using specific surfactant molecules dispersed in a colloidal liquid. The surface of the micelle constructs is modified with functional excipient penetration enhancers to which skin-rejuvenating molecules, hyaluronic acid among others, are coupled.

“The technology essentially allows the skin-enhancing ingredients to be transported across the stratum corneum and into the epidermis using ionically charged co-polymers as excipients,” Mr. Richard explains. “The penetration enhancer temporarily removes the barrier of resistance of the stratum corneum, and the surfactant helps to solubilize lipids within the stratum corneum.”

Studies demonstrate that the novel technology can successfully transport molecules of a wide size range (e.g., 50 kDa to 800 kDa hyaluronic acid) into the epidermis. The system can also be manipulated to target specific depths of penetration and provide both rapid and sustained effects.

The system also has potential for future development. For example, by allowing efficient, targeted and prolonged delivery of ingredients through the skin, the transdermal technology may assist existing topical medications to be used effectively and with better safety at lower concentrations. In addition, the novel delivery platform may provide an opportunity to develop topical formulations of medications that heretofore could only be administered via systemic routes.

Michael Gold, M.D., is a scientific adviser to Nuvesse and was also an investigator in the clinical trials. Speaking to Dermatology Times, he says, “It is always nice to see new skincare products that are backed by good clinical science become available to help our patients, and I am truly excited about Nuvesse^MD.”

“The novel delivery technology in these products allows hyaluronic acid and other constituents with known benefits to cross the epidermal barrier of the intact stratum corneum and enhance the skin across a wide range of appearance-related dermatoses,” says Dr. Gold, medical director, Gold Skin Care Center and Tennessee Clinical Research Center, and assistant clinical professor of dermatology Vanderbilt University School of Medicine, Nashville, Tenn.

Next: Clinical trials demonstrate efficacy and safety

Efficacy and safety

The clinical trials evaluating the products featured in the Nuvesse^MD line debut comprised four protocols and a total of 140 patients enrolled at four centers. The studies investigated use of the products to enhance the effects of a skin facial, a microdermabrasion procedure, after periocular cosmetic procedures, and following laser ablative treatments. Joining Drs. Gold and Werschler as study investigators were Vic Narukar, M.D., San Francisco, and Mitchel Goldman, M.D., La Jolla, Calif.

Photometric-based ratings by both the investigators and patients demonstrated improvements in skin appearance, and the study’s results also showed high interest among both the physicians and patients in using the product again.

“Patients in all four clinical trials found the products were well-tolerated and enhanced the outcomes of the procedures they had undergone,” Dr. Gold says.

Dr. Werschler says the high satisfaction of patients in the clinical trials was especially noteworthy.

“Patients like products that show a demonstrable effect, don’t sting or burn on application, and are easy to use,” he says. “Other treatments can rejuvenate the skin but have to be kept on for 12 to 24 hours. With the Nuvesse^MD products, patients can notice a benefit within an hour, and that is a huge difference.”

Mr. Richard points out that user safety was also a priority in developing the skincare products, which is why only GRAS materials are used.

“Our formulations contain nothing that can cause an irritant or allergic reaction, and they have a shelf-life of at least 24 months,” he says. “The delivery technology protects the ingredients from oxidation and cross-reactions, and the products contain a non-paraben agent to prevent microbial growth.”

Next: Brand launch features

Product performance

Dennis Condon co-founded Nuvesse with Mr. Richard and became its chief executive officer after leaving his position as CEO and president at Merz Aesthetics. He explains that he first learned of the novel delivery technology while exploring acquisition and licensing opportunities as a consultant to the industry.

“I was immediately impressed by this platform because it represents a first-in-kind system for topically delivering skincare constituents through an intact stratum corneum. Evidence of its efficacy was available through bench testing and we have subsequently confirmed its performance in clinical studies conducted at core research sites,” Mr. Condon says.

“It is not often that rigorous clinical trials are undertaken to demonstrate the efficacy of skincare products,” he says. “However, in pursing the aesthetic market, Nuvesse is maintaining a legacy of commitment to science and is dedicated to establishing a level 1 evidence base to support our products.”

The brand launch features four kits for facial use that will be available to consumers exclusively through a physician channel. One kit provides deep hydration and targets fine lines, a second is for firming and anti-aging, the third is for minimizing crow’s feet and other periocular fine lines, and the fourth is for improving the appearance of tired eyes and reducing puffiness and dark circles.

Each kit features a one-month supply of product in two different formats - a biocellulose masque intended for intensive treatment (worn for 25 minutes once a week) and a roll-on for maintenance care to be used on a daily basis.

Other kits are being developed for facial skin brightening and lightening of age spots, minimizing the appearance of fine lines and firming neck and décolletage skin, and for calming redness related to rosacea and acne in adults.

The Nuvesse^MD products will be showcased for the first time in the technical exhibit at the 10^th annual Vegas Cosmetic Surgery Meeting, held June 18-24.