Dr. SundaramTwo new fillers being launched in Europe could be game changers for cosmetic surgeons and their patients in the U.S., according to Washington, DC-area dermatologist Hema Sundaram, M.D.
From her international research and educational work, Dr. Sundaram has a pulse on what cosmetic dermatologists and plastic surgeons are doing worldwide, and there’s lots of chatter, she says, around a new, chemical-free, thermally crosslinked hyaluronic acid (HA) technology for skin laxity. Earlier this year, she chaired a symposium at the International Master Course on Aging Science (IMCAS) in Paris on the new HA technology by Italian pharmaceutical company, IBSA Farmaceutici, called ProfHilo.
BDDE, or 1,4-butanediol diglycidyl ether, is commonly used as a cross-linking agent in HA fillers. BDDE and other cross-linking agents have to be in balance to maintain HA filler duration and biocompatibility, and these agents can affect filler performance, according to a 2008 paper published in Clinical Interventions in Aging.
The U.S. FDA has standards for the levels of residual BDDE in HA fillers, which can be lower than those required for approval in other countries, according to Dr. Sundaram. While trace amounts of BDDE in HA fillers are considered safe, consumers find the idea of fillers that are free of BDDE and other chemicals very attractive, she says.
Many filler companies are engaged in development of BDDE-free HA technologies, but ProfHilo is the first to receive approval in Europe and elsewhere in the world. However, Dr. Sundaram explains that the key to success of these technologies is that they must offer something that currently available HA fillers don't. In the case of ProfHilo, this is a unique structure and cohesivity that allow the product to flow freely through subcutaneous tissue and the dermis, in a way that other HA fillers cannot. This makes ProfHilo ideal for anatomically challenging areas that have been difficult to restore previously, such as the forehead, neck and submalar regions, according to Dr. Sundaram.
NEXT: Examining ProfHilo Performance
Examining ProfHilo Performance
"The product won't produce lumps and bumps — even if it's injected as a bolus or lump. It flows within the fat compartments and skin layers to fill them evenly within 24 to 48 hours," she says. "This makes ProfHilo complementary rather than competitive to other HA fillers. We can combine it with the fillers we already use to finesse our results."
ProfHilo is a stabilized hybrid cooperative complex of low and high molecular weight HA, for skin remodeling and laxity. In vitro and mammalian studies have shown up-regulation of collagen and elastin production, with minimal tissue inflammation. Pilot clinical studies with high-resolution 3D imaging analysis show a remarkable volumetric effect, with a significant increase in volume of the midface beyond what was injected into it at 16 weeks after treatment. Torsiometry showed significant improvements in skin elasticity and firmness, according to Dr. Sundaram.
"This is the newest and most sophisticated addition to our toolbox of injectables," Dr. Sundaram says. "ProfHilo gives us the established restorative benefits of low molecular weight HA, without the disadvantage of inflammation which is removed by thermal linking to high molecular weight HA. The product produces even less inflammation than high molecular weight HA, which is known to be anti-inflammatory."
ProfHilo is biocompatible, as it is composed of pure HA alone, and has a reduced risk of side effects, as it is absent of additives. HA-DERMA will launch ProfHilo in the UK in June, according to Aesthetics, a UK-based publication for aesthetic physicians. Dr. Sundaram will chair the launch symposium at the FACE conference in London that month.
Even though Dr. Sundaram says she thinks ProfHilo will hit a chord with consumers because it’s BDDE-free, she predicts it will be a hit with injectors because of its performance.
"Over 50,000 syringes of ProfHilo have been sold in Italy alone over the past 10 months," she says. "This is just the beginning, as the product is now being launched elsewhere in Europe and worldwide. There is also strong interest in bringing it to North America."
NEXT: Behold Belotero Volume
Behold Belotero Volume
Merz launched Belotero Volume HA filler last year in Europe.
“Belotero Volume can go more deeply [than Belotero Balance] for contouring and deep volumization,” Dr. Sundaram says.
The filler, she says, could be a game-changer because of its compatibility with the tissue.
“Belotero Volume and ProfHilo behave very similarly to fat. They move naturally like fat,” Dr. Sundaram. “If you inject them into the fat compartments, it’s an extremely natural look. What we are moving towards is what I call dynamic restoration, which means that our results are completely natural in animation as well as in repose. It's a paradigm shift that is very exciting for all injectors.”
Belotero Volume approval is expected in the U.S., according to Dr. Sundaram, but not for 2016.
Disclosure: Dr. Sundaram serves as a clinical investigator and/or consultant for IBSA and Merz.
