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Injectable fillers are used in a variety of ways to improve the appearance of the aging face. However, because not all fillers are alike, it is important for dermatologic surgeons to understand the features and benefits of each product in order to optimize its clinical use, says W. Philip Werschler, M.D.
Wailea, Hawaii - Injectable fillers are used in a variety of ways to improve the appearance of the aging face. However, because not all fillers are alike, it is important for dermatologic surgeons to understand the features and benefits of each product in order to optimize its clinical use, says W. Philip Werschler, M.D.
Recently, the armamentarium of injectable fillers was expanded by the Food and Drug Administration’s approval of a novel hyaluronic acid (HA) gel product that holds the distinction of being the first filler indicated for correcting age-related midface volume loss (Juvéderm Voluma XC 20 mg/mL, Allergan). Dr. Werschler discussed this new filler option and other developments at the MauiDerm 2014 meeting.
Manufactured with proprietary crosslinking technology (Vycross), the new HA filler gel from Allergan flows easily and yet has increased stiffness, firmness and durability compared with other products in the HA category.
“Vycross technology produces a highly crosslinked gel that has enhanced longevity and lifting capacity, which opens up new opportunities for midface volumization,” says Dr. Werschler, who practices in Spokane, Washington, and is associate clinical professor of medicine/dermatology, University of Washington, Seattle.
The pivotal clinical trial leading to approval of the new filler was conducted at 15 sites in North America. It included 235 patients who were treated to correct midface volume deficit and 47 untreated controls. Eligible patients had moderate, significant or severe midface volume deficit as assessed using a six-point validated rating scale.
Patients in the treatment group received injections into one, two or three subregion treatment areas (zygomaticomolar, anteromedial cheek and submalar) and could receive a touch-up one month later to optimize the results. Median injection volume was 6.6 mL (range 1.1 mL to 13.9 mL). Follow-up visits were scheduled quarterly through 24 months.
Effectiveness was evaluated by two blinded investigators, and the primary endpoint was assessed at 6 months. According to the protocol, the product was considered clinically effective if at least 70 percent of patients were responders (i.e., achieved a ≥ 1-point improvement from baseline in the midface volume deficit scale); the primary endpoint was met as the responder rate at six months was 85.6 percent.
Duration of effectiveness was analyzed using Kaplan-Meier statistics, and the data on maintenance of correction showed patients rated their outcomes better than the investigators at all follow-up time points. Based on the patient ratings, the estimated probability of maintaining correction was 95 percent at six months, 80 percent at 12 months, and 54 percent at 24 months. According to the investigator’s ratings, the estimated probability of maintaining correction at six, 12 and 24 months was 77, 64 and 46 percent, respectively.
“These data indicate that improvement may persist for up to two years in about half of patients,” Dr. Werschler says.
“However, keep in mind that filler duration claims are a slippery slope, and I would encourage you never to give patients estimates using absolute numbers. Rather, suggest a range of time that leans toward the conservative side,” he says.
Next: Additional HA products
More HA products
Belotero Balance Dermal Filler (Merz Aesthetics), the HA filler using a proprietary cohesive polydensified matrix (CPM) technology, was also reintroduced recently. A main feature of this product is that it has less homogenous bulk. Therefore, it causes less monochromatic refraction of ambient light.
“Based on this property, we can Belotero Balance superficially in patients with Fitzpatrick skin types 1 and 2, and be relatively assured that these fair-skinned individuals will not have a bluish discoloration (Rayleigh effect),” Dr. Werschler says.
He also called dermatologists’ attention to another recently approved HA filler that is indicated for use as an intranasal splint (Expression, Enhancement Medical), but is being heavily marketed in the aesthetics community. It is produced using a nonpathogenic bacteria, Bacillus subtilis, in a water-based process that is touted for eliminating the risk of residual toxins and the need for organic solvents.
Looking ahead, Dr. Werschler notes that Allergan is conducting clinical trials with two other new HA formulations made with Vycross technology (Volbella and Volift). In addition, the recent acquisition of Anteis by Merz may result in more products in the Belotero family becoming available in the United States.
New products may also be forthcoming from Alphaeon, which has become a new player in the filler market. Alphaeon acquired the U.S. licensing rights for the HA filler and skincare line of Teoxane Laboratories, and it has several fillers and a neurotoxin in development, as well.
Disclosures: Dr. Werschler is a consultant, advisory board member, investigator, and or/speaker for multiple companies marketing filler products.