Two forms of JuvÃ©derm now marketed in the United States provide safe, effective corrections for nasolabial folds that last longer than those achieved by bovine collagen,phase 3 testing shows.
Miami Beach, Fla. - Both forms of Juvéderm (Juvéderm Ultra and Juvéderm Ultra Plus, hyaluronic acid/HA, Allergan Medical) available in the United States provide safe, effective filler options for treating nasolabial folds, according to an expert.
In a recent study performed as part of Juvéderm's Food and Drug Administration (FDA) phase 3 testing, these fillers achieved corrections lasting up to six months and more, according to Leslie S. Baumann, M.D., professor of dermatology, University of Miami, Miami Beach, Fla., and lead investigator in the phase 3 trials.
While HA is hardly unique, she says, "Juvéderm represents another safe form of HA on the market" that provides longer-lasting corrections than bovine collagen and as such is producing high patient satisfaction.
The study protocol required investigators to:
Researchers gave patients up to three treatments over a four-week period, then followed up with patients every four weeks for up to six months after their final treatments.
While all three fillers achieved statistically significant improvements in nasolabial fold severity scores at every time point during the 24-week follow-up period, improvements achieved by the HA fillers lasted longer than those achieved by bovine collagen, Dr. Baumann says. In particular, 24 weeks after the final treatment, the mean improvement in nasolabial fold score was still clinically significant (at least a one-point improvement from baseline) in the HA-treated nasolabial folds, but not in those treated with bovine collagen, she adds.
At 24 weeks post-treatment, 90 percent of nasolabial folds treated with Juvéderm Ultra Plus still showed clinically significant improvement, while the corresponding figure for Juvéderm Ultra was 88 percent. In contrast, only 36 to 40 percent of nasolabial folds treated with bovine collagen still showed clinically significant improvement at this point.
"It makes sense that Juvéderm Ultra Plus lasts longer than Juvéderm Ultra, because Ultra Plus is more highly cross-linked than Juvéderm Ultra," Dr. Baumann tells Dermatology Times.
All three fillers exhibited a similar safety profile, occasionally producing side effects (such as erythema, induration, pain, edema, nodule formation, bruising, pruritus and discoloration) that were limited to the injection site and resolved themselves within a week, she says.
Among HA-based dermal fillers, Dr. Baumann says, "Restylane (Medicis Aesthetics) and Hylaform (Allergan Medical) were the first to the market. But now we have Hylaform Plus (Allergan Medical), Captique (Allergan Medical) and two kinds of Juvéderm. So we went from two choices to six. There's a lot more variety on the market now."
Currently, Dr. Baumann adds, no formal head-to-head comparisons between HA fillers exist. Accordingly, she says, "We really don't know how HA fillers perform compared to each other, except anecdotally. I'd love to see a trial pitting some of the more popular HA fillers head-to-head."