National report - Results of a pivotal study evaluating a new generation hyaluronic acid (HA)-based gel filler (Juv?derm, Allergan) for correction of nasolabial folds show that all three formulations of the injectable product provide significantly greater and longer-lasting improvement than crosslinked bovine collagen (Zyplast, Allergan) reports Leslie Baumann, M.D.
National report - Results of a pivotal study evaluating a new generation hyaluronic acid (HA)-based gel filler (Juvéderm, Allergan) for correction of nasolabial folds show that all three formulations of the injectable product provide significantly greater and longer-lasting improvement than crosslinked bovine collagen (Zyplast, Allergan) reports Leslie Baumann, M.D.
The HA filler was approved for marketing by the Food and Drug Administration (FDA) in June, 2006, and is available as a family of three products, J24HV, J30HV and J30, which vary with respect to their amount of HA crosslinking and formulation consistency. The line is based on proprietary technology (Hylacross) that facilitates the production of particle-free, malleable smooth gel fillers able to flow easily when injected.
All patients were randomized to receive one of the three HA fillers into the nasolabial fold on one side of the face and were injected with the bovine collagen on the contralateral side.
All injections were delivered by a treating investigator into the mid-dermis under topical anesthesia using a 30-gauge needle. Based on the judgment of a second, masked evaluating investigator, up to two touch-ups were allowed over the next four weeks to achieve optimal correction.
Follow-up visits were scheduled at least every four weeks for up to 24 weeks after the last injection, and both the patients and evaluating investigator rated the severity of the nasolabial fold on a scale of zero (none) to four (extreme). All fillers resulted in significant improvement in nasolabial fold appearance. The peak benefit was achieved at two weeks after the last injection in all groups. However, at that visit and all visits thereafter, there were differences favoring the HA fillers in the magnitude of improvement. The differences increased as follow-up continued due to more rapid dissipation of the benefit in the collagen-treated side.
"This family of HA fillers based on novel technology has been available in Canada and Europe for many years and has demonstrated favorable performance with respect to injection ease, tolerability, safety, efficacy in providing natural-appearing correction and longevity. The results of this clinical trial demonstrate their superiority to crosslinked bovine collagen. Their more durable efficacy seems to translate into greater patient satisfaction, and so these new filler products are certainly a welcome addition to our options for soft tissue augmentation," Dr. Baumann, tells Dermatology Times.
She was the lead investigator in the pivotal trial and is professor of dermatology, University of Miami, and director, University of Miami Cosmetic Center, Miami.
The HA in the new filler products is derived from Streptococci equi. In addition to being particle-free, they differ from other HA filler products (Restylane, Q-Med; Hylaform, Allergan) with regard to containing both a higher concentration of HA and a higher amount of crosslinked HA.
To be eligible for study participation, patients had to have nasolabial folds that were approximately bilaterally symmetrical with severity ratings of two (moderate) or three (severe). The enrolled subjects had an average age of 49 years, were predominantly female (92 percent), Caucasian (74 percent), and Fitzpatrick skin types 2 or 3 (59 percent), although the entire range of skin types was represented in the study population.
Clinically meaningful differences
According to the investigators' ratings, mean nasolabial fold severity at baseline was 2.5 to 2.6 across all treatment groups.
At the time of maximum benefit, the improvement from baseline ranged from 1.9 to 2.1 points in the HA filler groups compared with 1.8 to 1.9 points in the collagen groups. At 24 weeks, the mean change from baseline ranged from 1.2 to 1.4 points in the HA filler groups and from 0.3 to 0.5 points in the collagen groups. Similar results were obtained in the subjects' self-assessments.
"A one-point improvement represents a clinically significant change, and at 24 weeks, 80 to 88 percent of subjects in the HA filler groups maintained that level of benefit. On the collagen-injected facial sides, the average improvement was no longer clinically significant and only 36 to 45 percent of patients maintained a one-point or greater change from baseline," Dr. Baumann reports.