Novel Aesthetic options expected to make a splash in the United States in 2011 include new hyaluronic acid (HA) fillers, a new topical treatment for redness and a recently approved device for nonsurgical facelifting. Several dermatologists reported on these and other Aesthetic products either recently approved or under review by the Food and Drug Administration (FDA), at the 2010 Cosmetic Surgery Forum in Las Vegas in December.
HA fillers on the U.S. horizon include Belotero (Merz) and Prevelle Lift (Mentor). Both are under review by the FDA, says Hema Sundaram, M.D., a Washington dermatologist and cosmetic surgeon in private practice. Prevelle Lift is approved in Canada and Europe, she says.
"They're both fascinating fillers, and at opposite ends of the spectrum in terms of how they behave. Belotero is a soft filler that can be injected superficially to provide tension volumization - adding a bit of turgor back to the skin superficially." As such, she says, "It's very good for fine lines and crepey skin."
Its pliable consistency reduces discomfort for the patient, she says. Dr. Waldorf is associate clinical professor of dermatology, Mount Sinai Medical Center, New York.
In fact, Dr. Sundaram says, "Belotero has low viscosity and elasticity," the latter known as G prime. In contrast, she says Prevelle Lift has the highest G prime, or elasticity, of any dermal filler.
"While Belotero provides the ultimate spread and softness, Prevelle Lift offers ultimate lift and firmness. It's injected deeply to provide what I call deep tissue lifting volumization," Dr. Sundaram says.
Understanding the science
Dr. Sundaram says aesthetic dermatologists "started off with fillers that chased wrinkles by filling in the lines. Then we moved to volumizing and contouring of the face with deeper fillers. And now, the next big move will be relying on rheological tailoring - understanding the science behind the fillers, especially their flow-related properties, so that we can match the right filler to the right purpose or application. We now have an array of filler products, and more on the horizon to provide deep tissue lifting or superficial tension volumization, as required (Sundaram H, Voigts B, Beer K, Meland M. Dermatol Surg. 2010;36 (suppl 3):1859–1865)."
Introduced in Europe in 2005, Belotero is now the second-most popular HA filler there, Dr. Waldorf says.
"While Europe has three forms - Soft, Basic and Balance - here we will have the Basic," she says. "However, we will be able to give it more of the consistency of the Soft version by diluting it with a larger amount of anesthetic."
Along with Prevelle Lift, she says, dermatologists will continue to use Radiesse (calcium hydroxylapatite, BioForm/Merz) and Sculptra (poly-L-lactic acid, Sanofi-Aventis/Dermik) for large volume filling. Juvéderm Voluma (HA, Allergan), also for lifting via deep injection, is also on the U.S. horizon, she says. At press time, Allergan had initiated U.S. clinical trials of Juvéderm Voluma, says Kellie Lao, Allergan's manager, corporate communications.
"One thing I'm hoping will be forthcoming is a larger syringe for Radiesse," Dr. Waldorf says. Its maker now offers the largest syringe among dermal fillers (1.5 cc), "but there is potential for a 3 cc syringe, which would be helpful since we tend to use Radiesse in large quantities for volumizing," she says.
Dr. Waldorf says she also hopes the product earns the FDA indication for rejuvenating the hands, which a phase 4 trial is now evaluating. "That will get the message out to patients that we can use Radiesse in the hands," she says. The FDA is currently reviewing study data for this indication, Dr. Sundaram says.
Innovation for redness
Another interesting development is that SkinMedica is developing a new topical therapy for redness associated with rosacea and other skin conditions, Dr. Sundaram says. "Erythema of the face is one of the most challenging problems to treat. This particular topical therapy blocks release of prostaglandins C2 and D2 and other inflammatory mediators. It's been shown to be more effective for facial redness than prescription-strength topical metronidazole. Look for it in 2011."
Among recently approved devices, Dr. Sundaram says, "The Ulthera System (Ulthera) is a completely new type of ultrasound device for nonsurgical face lifting. It's the only device that has FDA clearance for nonsurgical lifting of the brows." In clinical studies, she says, researchers were able to quantify the device's lifting effect (Alam M, White LE, Martin N, et al. J Am Acad Dermatol. 2010;62(2):262-269).
Ulthera uses intense focused ultrasound, which allows physicians to visualize the plane of tissue as they're treating it, making treatments very precise, she says. "With my patients, I'm observing very impressive results with no downtime," Dr. Sundaram says. "It's an exciting technology for the future - a new paradigm in facial rejuvenation, and we will be conducting further studies on it in 2011."
Disclosures: Dr. Waldorf is a consultant and trainer for Allergan, Medicis and Merz, and a trainer for Solta. Dr. Sundaram is clinical researcher, adviser and/or consultant for Medicis, Mentor, Merz, SkinMedica, Suneva, Syneron/Candela and Ulthera.