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"Today I wanted to answer a few of the questions that we've had about the new injectable HA filler, Allergen's Juvederm Voluma. Voluma is another in the family of HA or hyaluronic acid filler, which are in a sense long chain sugars, commonly found in our body, that are used as injectable products for volume enhancement and line treatment.
Many people are familiar with Juvederm, Restylane, Perlane and Boletero, and now Juvederm Voluma, a product that is specifically indicated for volume enhancement. It's designed as such that it will last a very long time and that's what the studies show, which we'll get into in a minute, and it was specifically indicated for the mid-face volume loss that's common in facial aging. This doesn't mean it's limited to use there but that's the on-label indication for Voluma.
What we've seen is that this product may replace a lot of the other volumizing fillers which use inflammatory processes to essentially create the volume, and don't have as long of duration of effect.
So let me talk a little bit about these studies that lead to Voluma's approval and then I'll talk a little bit about how we use it in our practice, and in general how it is being used across the country, from the prospective of the key opinion leaders that we're invited to the launch in Southern California a few months ago.
The Voluma Clinical trials that we're done by the FDA looked at a series of 282 patients over 15 sites, and the specific indication was in mid-face volume loss. Now these areas were divided, as you can see, into regions or zones of the face that included the mid-face zone, or the anteromedial cheek, the zygomatic or cheekbone, and then the submylar zone. Each of these zone were addressed independently as being fully corrected or not, and there was a series of pictures taken for each of the patients throughout the study to look at volume.
What we can see, is the effectiveness of the drug over time, or the device, more specifically, over time and when we're looking at the response rate of patients, we can see that 86% of the patients in the treatment group were considered responders of the primary endpoint, and that duration in months, as you can see, went out to really, almost 24 months for over half of the subjects that were treated. So, even those patients that were not fully corrected still had some correction at the end of two years of the study.
Now the product itself is used by injecting into zones of the mid-face, and we can see an example of the typical patient here for the study, where mid-face zone was treated, or is being treated for, volume loss.
In this patient, a 61 year male, who had 6cc's originally and a 1cc touch up, that's 1 milliliter or syringe, and better shown on this 3 quarter view, where the volume enhancement is really significant. You can see the edge of his cheekbone here and then the after treatment the cheekbone looks fuller.
Another patient that had a 6ml treatment with a touch up and the improvement in the mid-face volume, softening of the lines and even just some of these contour changes that were visible are clearly apparent.
The treatment itself is done with a small needle. Topical application of numbing medicine can be used or just a little bit of ice, but the product voluma does have local anesthesia in it, and targets include the mid-face, as were done in the study, but you can also do areas like the temple or jawline.
You can see in this example, the patient look before, immediately after the treatment, and then two years later, still a very good correction from her baseline to after the treatment itself. So I'm quite excited and I think most of the investigators and key opinion leaders in the field are excited about this drug.
A 56 year old woman, very flat through the cheeks here, restoration of the cheek bone in a very natural way and we're using this in other areas too, we can see this mid-face zone but the temporal area, the jawline areas might also be good targets for use of the product.
These are immediately after the treatment in an older gentlemen and a series of these patients can be shown and I'll kind of go through them quickly but it's fairly dramatic the improvement that is seen. It can be done with any filler but the difference is that you don't get a lot of swelling after this treatment, you don't have to wait for a period of time for the volume to fill up, it's an immediate and enduring effect and its one that lasts for up to 2 years and beyond in many patients.
The product can be used in younger patients, when we see this distribution of volume being reduced, and this is a side view showing the examples of those patients.
Younger and older patients can see improvement and overall volume, a very sharply defined cheekbone in this lady who'd like a little bit less angular, a little more roundness of the face. What we've found from the study was that it was a very safe medication to use for mid-face volumization, again jawline, temporal regions can also be used, and really it's a product that I think is going to change the way we think about volumizing in our patients for the future.
So in summary I'd say that Juvederm Voluma, is a new product that's an HA filler used for mid-face, temporal volume loss, as well as contouring along the jawline, areas where we'd like long duration of true volume correction.
I don't know if it will replace autologous fat injection or transfer as a means of creating mid-face and other facial volume losses, but it's certainly one that can be done in the office within an enduring 2 year-effect, and so that's a significant advance in strategies that we have for using soft tissue fillers for the aging process.
If you have any questions about Voluma please don't hesitate to call our office at 415-567-7000.
Visit the website at Maasclinic.com or of course you can visit our video blog DrMaas.com, and we're open to any questions, photographs if you want, and video questions that we can answer and share with others. Dr. Corey Maas on Looking Your Best."