This month, in the ASJ, comes another study looking at the Botox versus Dysport battle.  Patients are always wondering – “which one is best?”.  Some patients swear they do better with one medication compared to the other.In this paper, a randomized, controlled study, 53 patients had Botox on one side of the face, and Dysport on the other.  They were then followed for 150 days to see how they did.  The usual conversion ratio of 2.5 units of Dysport to 1 unit of Botox was used, in equal volumes of solution.

 

Results:  no difference – in this trial, both sides were totally comparable and equal, from day 2 out to 150 days post-injection.

As I’ve  said before, it’s a bit of the “Coke versus Pepsi” situation… pick your favorite, as both Botox and Dysport are both equally effective.  And of course, we offer both here at our Orlando office.

Sculptra Aesthetic (injectable poly-l-lactic acid) logo

In a $425 million deal, Valeant Pharmaceuticals has purchased the dermatology unit of Sanofi-Adventis.  For us, this means that Valeant will now be in charge of marketing Sculptra, the facial injectable filler agent.

Sculptra is different than other dermal injectable fillers, like Restylane or Juvederm. It stimulates your body to produce some lost collagen, which can gradually improve the quality of the skin and reduce wrinkling and deep hollows. It also lasts up to two years. It’s been quite helpful in restoring hollow cheeks and temples, as well as improving deep naso-labial folds. It’s quite popular here at our Orlando office.

According to our Sculptra rep, we may be seeing more direct-to-consumer marketing of Sculptra with the new owners, but little else will change.  So far, we haven’t heard about any pricing changes, either.

Sanofi, apparently decided to divest its dermatology business with the intention to further concentrate on its core products.

With the advent of the new botulinum preparation called Xeomin, many people are wondering which one is better – Botox, Dysport or Xeomin?  Here’s what we know, scientifically speaking:

1)  A comparison study (here) of Botox versus Xeomin for wrinkles in the glabella (frown lines) found these two products to work virtually the same, according to independent raters.

2)  Botox and Xeomin spread out through the tissues to the same extent, so the patient’s response to the placement of a given dose is very similar.  (study #2 here)

3)  The potency (LD50) of Botox and Xeomin is very similar – so the dosing is the same.  No conversion ratios are needed.  (study #3)

4)  Xeomin worked identically as well as Dysport in a comparison test in the crow’s feet area, when the usual 3:1 conversion ratio was used.  (study #4)

Conclusions:  So far, the three preparations work in a very similar manner for the treatment of dynamic facial wrinkles.  There’s no convincing study – as of today – that shows a clear winner.

In other words, people, what we have here is a three-way version of “Coke vs. Pepsi”.  Pick your favorite…they all work.  We have all 3 of them available at our Orlando, Florida office.  Come on in and give your favorite a try!

The U.S. Food and Drug Administration (FDA) has approved another use for Restylane Injectable Gel: this week the agency gave its official blessing to use the filler for lip augmentation.

Restylane was previously approved to treat facial wrinkles. While we have long used it for lip augmentation, this was known as an unofficial or “off-label” use. Restylane is the first filler to get the FDA’s approval for this particular use, something that Allergan, the makers of Juvederm, are probably jealous about!

In the multi-center study that Medicis, the makers of Restylane, presented to the FDA, Restylane was found to be highly effective for lip augmentation, for up to 6 months. It did not have any serious side effects. About 80% of patients liked the results so much that they signed up for a second treatment after 6 months.

This is certainly our experience here at our Altamonte Springs office: both restylane and juvederm work very nicely to shape and fill the lips in a pleasing and natural-looking way. Patients love it!

Free botox – sounds too good to be true, right?

Of course, there’s a catch – but for the month of October 2011, we’re offering a simply unbeatable deal. We want our loyal friends & customers to help us “spread the word” about our Botox services – so we’ve cooked up this fantastic “Botox buddy” October promotion to help introduce new patients to our practice. It’s great for them, and a deal for you!

Here’s how it works:

Bring a friend – your Botox Buddy – in for Botox with us, and:

– your friend will receive the first 10 units of Botox (a $140 value) free,

– and you will receive the highly discounted rate of $10/unit for your first 25 units of Botox.

And you can bring in as many friends as you like…which could earn you that much more in Botox savings, and make you extremely popular with your Botox buddies!

Here’s the fine print:

– while supplies last,
– you must have previously received botox or dysport from us,
– you and your friend(s) must receive the treatment on the same day,
– your friend must be a new patient to us, and must be a candidate for the treatment,
– offer can not be combined with other specials,

Just this week, the FDA has approved another competitor for Botox. This one is called Xeomin, and it’s sold by Merz Aesthetics.

Just like Botox and Dysport, it temporarily reduces wrinkle lines, such as the frown lines between the eyebrows. However, Xeomin does not require refrigeration prior to reconstitution and mixing. According to the manufacturer’s press release, Xeomin will be available in the spring of 2012.

One of the subtle differences between these 3 products is that Xeomin has a lower “protein load” than either Botox or Dysport. This might be helpful for the rare person that has developed antibodies to either Botox or Dysport.

Also, unlike Dysport, the dosages used are the same as Botox® Cosmetic – so direct comparison of the treatment effect is much easier.

So the big question: will more competition bring the wholesale price of the product down? While that would be nice, I’m skeptical that it will happen. Time will tell.

A few years ago, there was an FDA-approved injectable filler product called Isolagen. The company, however, couldn’t get their financing together, and went bankrupt in 2009. But now, rising from the ashes, the product is back, under a new name, laViv. The product just received FDA approval last week. But, to my review, it’s basically Isolagen with new packaging!

Here’s how it works: think of it as a personalized wrinkle filler. You take a small biopsy of skin, from behind the ear, where there isn’t much sun damage. Then, send that off to a specialized lab, where the fibroblast cells are isolated and grown in cell culture for 3-6 months. Then, you can have some of those fibroblasts – your own cells – injected into wrinkled areas, where they go on to manufacture collagen and fix the wrinkle, in what will hopefully be a semi-permanent way. The rest of the cells are kept for your future use, so you don’t need a repeat biopsy.

The wrinkle-fighter been shown to work in randomized clinical studies…but not necessarily better than other FDA -approved fillers. Those comparison studies have not yet been done. And since these are your own cells, the results look very natural, and the treatment is well tolerated, other than the risks of the injection, like bruising and swelling.

The manufacturer, FibroCell Science, has not announced a price, but a spokeswoman said it was expected to be $1,000 to $2,000 to create the personalized cell bank, and then perhaps $300 to $500 for each of the three treatment sessions.

So, the big question: will people pay the difference for customized cell therapy, or stick with Juvederm and Restylane, which are considerably less money, but require ongoing upkeep?

While it seems hard to imagine today, back before the early 1980’s, plastic surgeons didn’t really have any reliable injectable products to use for wrinkle correction or lip enhancement. When Zyplast and Zyderm arrived in the early 80’s, a new generation of of non-surgical corrections via injectable fillers became possible. These bovine-collagen fillers weren’t by any means perfect – they required skin testing, had a potential for allergic reactions, and didn’t last all that long. Still, they caught on like wildfire, and were used by millions worldwide with reasonable results most of the time.

Today, we hardly use Zyplast, Zyderm, Cosmoplast and Cosmoderm anymore. They have long been replaced by better products, like Juvederm and Restylane. The newer HA gel products are easier to use, are available in a variety of consistencies and formulations, don’t need skin testing, have a far smaller risk of allergic reactions, and can be “erased”, if need be, by an injection of hyaluronidase. It’s a big improvement.

Earlier this year, Allergan announced that the old generation of collagen fillers would no longer be distributed at the end of 2010, due to lack of demand. (Allergan actually stopped production of the products in 2009, but had enough inventory in stock to meet the projected demand for another year.)

Should you be worried? No. In addition to Restylane, Perlane, Juvederm, Juvederm Plus, Prevelle Silk, Radiesse, Selphyl, Sculptra and others, new filler agents like Belotero are just around the corner. You’ll still have plenty of excellent choices. Technology has advanced, and we have considerably better choices now.

Answer: Maybe. Lithera, Inc. – a privately held pharmaceutical research group, recently presented some exciting results of a randomized, double-blinded study of their new injectable lipolysis drug, called “LIPO102″ at the ASDS meeting.

In the study, volunteers were injected weekly in 22 locations in the abdomen and flanks with the drug, over 8 weeks. On average, the study group lost about 1/2” more of abdominal circumference than the control group did, without diet or exercise. Computerized 3-D imaging was used to take the measurements.

The fat reduction worked best in patients who were younger than 40 years and relatively thin.

Here’s the interesting part: the ingredients in LIPO-102 are salmeterol xinafoate and fluticasone propionate. Asthma patients might recognize these medicines better as the very same ingredients that are used in Advair, the FDA-approved inhaler. The same beta receptors that are used to help relax the airways for asthma and COPD patients are also found on fat cells, where a beta agonist can trigger lipolysis. Dosing and administration, of course, are quite different between the two products.

Kybella Injections for Double Chin Reduction Before After Pictures

Kybella for Chin Fat Reduction Before & After Photos

Kybella Injections for Double Chin Reduction Before After Picture

Kybella for Chin Fat Reduction Before & After Photos

Lithera isn’t the only group with an injectable agent for melting fat, though. Kythera Biopharmaceuticals is also working on the same concept, with a totally different injectable formula called “ATX-101” (Kybella now FDA approved 2015) which is also in the testing phase.

Impression: All very exciting, but very preliminary stuff. It may be the next generation of non-surgical body contouring, or it may turn out to be more trouble than it’s worth. Much more research is needed.

According to multiple reports, the FDA today approved the use of Botox, the wrinkle fighter from Allergan, for chronic migraine headaches. (link)

“Chronic migraines” are those that occur more than 14 days out of each month. Botox has not been shown to work for the treatment of episodic migraine headaches, or for other forms of headache. The Botox treatments are given every 12 weeks, which could get quite costly. I’m sure though, that the people that suffer through the pain, nausea and vomiting and light sensitivity of repeated migraines will be happy to have another treatment option.

And they’ll have fewer wrinkles, too!

RealSelf
Plastic Surgery In Florida