from the Winter 2007 issue
As the New Year begins, we are pleased to introduce JUVÉDERM™ Ultra and Ultra Plus, two new facial fillers from Allergan, Inc., the maker of BOTOX® Cosmetic. Approved by the FDA in June 2006, JUVÉDERM injectable gel is a hyaluronic acid (HA) dermal filler with a technologically-advanced formulation. That formulation results in a malleable smooth gel that flows easily into the skin, creating a smooth, natural look and feel. JUVÉDERM also contains the highest concentration of non-animal and cross-linked HA of any dermal filler. Based on findings from its FDA clinical trial, these attributes provide optimal results with a single treatment in the majority of patients with the correction lasting up to six months or longer.
HA is a natural complex sugar found throughout all living organisms. It retains water, absorbing up to 1,000 times its weight and, thus, can add volume to the skin’s surface. Restylane®, approved by the FDA in 2003, is the best known HA filler, and we have been using it successfully for over three years to restore volume and correct the appearance of facial wrinkles and folds. It’s the cross-linking of the HA, according to Allergan, that makes JUVÉDERM unique. Cross-linking is a chemical process in which individual chains of HA are chemically-bound (cross-linked) together, changing liquid HA into a gel – the firmer the gel, the greater the degree of cross-linking. Our bodies absorb cross-linked HA more slowly, resulting in a longer duration of effect.
JUVÉDERM is available in two formulations. JUVÉDERM Ultra with less cross-linking HA is for more versatility in contouring and volumizing facial wrinkles and folds. JUVÉDERM Ultra Plus is a more highly cross-linked robust formulation for volumizing and correcting deeper folds and wrinkles.
Of the two formulations, JUVÉDERM Ultra is the one competing most directly with Restylane. So which is better or lasts longer? Since there have been no head-to-head double-blind, randomized and controlled clinical trials in the U.S. comparing these two fillers, the answers to those questions are unknown. The FDA’s approval of JUVÉDERM was based on a clinical trial comparing various formulations of JUVÉDERM against ZYPLAST®, a collagen dermal filler.
In Canada, JUVÉDERM has been available for five years, and according to Jean D. Carruthers, M.D., clinical professor of ophthalmology at the University of British Columbia, "It has never really caught on in Canada the way Restylane did." Dr. Carruthers believes that a lack of focus on the product by Inamed, whom Allergan acquired in March 2006, may partly account for this result. “It will be hard for JUVÉDERM initially to budge Restylane, because Restylane has been the ‘gold standard’ among cosmetic fillers,” Dr. Carruthers says. However, she goes on to say, "The initial research seems to show that there are some benefits of JUVÉDERM over Restylane in terms of perhaps slightly easier flow when it's being injected, and possibly slightly less swelling after injection.”
Our position is we think both fillers will provide excellent results for our patients, and we see the addition of both JUVÉDERM gel fillers as more weapons in our arsenal to combat the signs of aging.
We are currently a little over a month into Allergan’s JUVÉDERM Experience Trial (JET) being conducted in our Center for Skin Research. JET is a multi-center, open-label experience trial to evaluate persistence and satisfaction with JUVÉDERM Ultra. There are 12,000 patients nationwide participating in JET. All have undergone correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Patients are to return for follow-up examination by their treating physicians three, six and nine months after their JUVÉDERM treatment. JET is not a formal clinical trial like the one used to approve JUVÉDERM, but it has given us a chance to try this exciting new product several months before its launch.
Adverse effects should be similar to those possible with other dermal fillers. You may experience swelling, lumps/bumps, bruising, itching, and/or discoloration at the injection sites. All should resolve in seven days or less.
If you are interested in trying this new line of injectable fillers, please call for a consultation with one of our dermatologists at 713.850.0240.
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