Monthly Archives: March 2017

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Global perspecitves on cosmetic fillers

Haasan I. Galadari, M.D.

With so many new and exciting filler products in the U.S. pipeline, American dermatologists and their patients are in for a treat, according to Hassan I. Galadari, M.D., who presented “Up and Coming Fillers: Experience from Across the Atlantic,” on March 4 at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Fla., March 3 through 7.

Dr. Galadari, an American board-certified dermatologist who practices in Dubai, says there are more than 80 companies that produce hyaluronic acid (HA) fillers worldwide.

“…though not all will be approved in the U.S., the larger companies–those who push the envelope in the areas of research and development–will be introducing their products to the U.S. very soon,” Dr. Galadari tells Dermatology Times.

A trend among filler companies is to focus on adding products that cater to certain parts of the face, he says.

“In the U.S., doctors are made to dilute their fillers in order for them to safely use them in certain parts of the face–say the tear troughs under the eyes, for example. That will change with the introduction of newer softer products that have been approved for those indications,” Dr. Galadari says.

Recent U.S. approvals for Restylane’s Refyne and Defyne (Galderma) fillers occurred long after the rest of the world began using those fillers. The newest Galderma HA fillers in the U.S. have been in use in other parts of the world since 2010, as part of Galderma’s Emervel line.

HA fillers are not the only potential new kids on the block. Non HA fillers will be entering the U.S. market soon. While not much has changed with poly-L-lactic acid (PLLA) and calcium hydroxylapatite (CaHA) formulations, a filler containing polycaprolactone (PCL) is in the pipeline to be approved in the U.S., according to Dr. Galadari.

“PCL is a bio-stimulatory filler that comes in four different formulations of different longevities, without affecting its viscosity and no change in extrusion forces. The longest in the range, which can last up to four years, may be used for those with structural anomalies or defects, such as HIV lipoatrophy and even acne scars,” he says.

Avoiding, addressing potential complications

Filler use is not without complications. The good news is there are ways to address and avoid them.

Swelling is one of the most common adverse filler-related effects. Different fillers—even those in the same category, such as HA—behave differently, according to Dr. Galadari.

“Depending on the concentration of short and long chain HAs in the product, the degree of swelling varies. Swelling is transient, but there are some products where the swelling can last more than two weeks, and, for patients seeking fast and immediate beautification for an event, [that might not be acceptable],” he says.

Bruising can result, especially when treatment involves many injection sites.

“Needles, potentially, can statistically cause more bruising to happen as compared to a cannula. That’s why the use of cannulas have risen. Cannulas are great tools, but their limitation may lie in the fact that they can only inject the deeper plane and not the dermis. The superficial lines need to be injected with needles,” Dr. Galadari says.

Lumps can occur with use of any product. And when they do with HA fillers, injectors can simply dissolve them by injecting hyaluronidase.

“The same cannot be said with non HA fillers, which may require the injection of saline to help soften the lump, but not essentially dissolve it. Granulomas are distinct lumps that have to be proven histopathologically,” he says.

Biofilm can occur with any product but are common with HA fillers. The only way to remove biofilm is with complete removal of the product and a course of antibiotics, according to Dr. Galadari.

“Intralesional steroid use has fallen out of favor and is not as common as in the past, given that [the steroids] may cause more harm than good in terms of causing atrophy to the surrounding tissue,” he says.

Neurovascular compromise, while not the most common adverse event, is the most alarming. Necrosis can ensue if it is not correctly identified. If that happens, the effect is usually long lasting scarring. It is important to be able to identify this as quickly as possible, according to Dr. Galadari.

“Patients may present in two different ways. The first is immediate blanching of the area where the filler is being injected. This identifies an embolism, an intravascular injection of the filler. If this occurs, then immediate cessation of injection should be done, followed by flushing of the filler with a high concentration of hyaluronidase for both HA and non HA fillers. Manual massage is important as this recruits surrounding blood vessels to the area. Warm compresses may also be applied. [Nitroglycerine] paste may also be used. Patients should be injected repeatedly with hyaluronidase every 30 to 60 minutes before leaving the clinic to ensure that circulation has been reestablished in the area. Aspirin and sildenafil have also been prescribed to be used at home as an antiplatelet and vasodilator respectively,” he says. “The other feature of impending necrosis can occur when at home. Patients usually complain of severe pain and tenderness within the first 24 hours. If patients do so, the doctor should immediately ask them to come to the clinic and the steps delineated above should be performed.”

On the horizon

Teoxane’s Teosyal Resilient Hyaluronic Acid (RHA) line will introduce one of the newer fillers to the U.S. market, according to Dr. Galadari.

“This will be distributed by Alphaeon in the US. The filler will be approved by the end 2017 or beginning of 2018,” he says. “One of the advantages of this filler is its ability to stretch in areas of dynamism, especially the mouth, but without compromising its lifting effect. The filler holds an advantage of becoming integrated to the surrounding tissue and is extremely forgiving, in the unlikely event of when a lump occurs. Preliminary work in the lips and perioral lines are very promising.”

Other newcomers to the U.S. filler market, according to Dr. Galadari, include additions to the Merz Aesthetics Belotero line, including a volumizing HA. Galderma and Allergan will also continue to introduce fillers that have been available in Europe and the rest of the world, he says.

Dr. Galadari offers these three best practices for filler use:

Choose the right patient. If you don’t have the right patient and decide to inject anyway, you will have an unsatisfied patient. Ask patients specific questions to understand their expectations and to determine whether filler injections are right for them.

Choose the right filler for the right area. It’s extremely important for doctors to understand filler properties, both physiologically and histologically. A dermatopathologist showcased the importance of this point during Dr. Galadari’s AAD session.

Some examples: If a filler with high elastic modulus, or G’, is injected in the lips or tear troughs, the filler will have a tendency to create highly undesirable lumps. The same thing can be said if the injector uses fillers with a lower G’ in the cheeks. He or she will need a huge volume to get a lifting effect, which can be quite costly for the patient. That being said, biostimulatory fillers should be avoided in general in areas of the lips and tear troughs. With the upcoming introduction of softer HA fillers , areas which were considered taboo, such as the glabellar complex, where many reported cases of necrosis have occurred in the past,  may now safely be injected provided that anatomic knowledge of the area is adequate.

“Currently, there are low-G’ HA fillers that can be safely injected in that area provided a ‘correct’ approach is undertaken to avoid pitfalls,” he says. “With the newer fillers being approved, we can now safely inject the correct filler for those anatomical spots.”

Choose the right injection technique. Recent adverse events (even blindness) resulting for cosmetic filler treatments draw attention to what can happen when injectors use inappropriate injection technique and have limited understanding of the anatomy.

Disclosure: Dr. Galadari is a speaker, faculty member or investigator for Sinclair Pharma (previously Aqtis Medical), Merz Aesthetics and TEOXANE Laboratories.

The Skinny on fat reduction, cellulite devices

Coolsculpting January 18, 2017

By Lisette Hilton – Modern Medicine Network

Devices aimed at reducing fat and ridding patients of cellulite’s unsightly bumps look magical in promotional ads, but how do dermatologists look beyond to choose the best technological arsenal for treating their patients? We asked for unplugged advice from Chapel Hill, N.C., dermatologist Sue Ellen Cox, M.D., who presented on fat reduction and cellulite devices in November at the 2016 American Society for Dermatologic Surgery (ASDS) annual meeting in New Orleans.

The reveal

There are plenty of noninvasive fat reduction devices. Nuances help differentiate them.

Dr. Cox’s noninvasive fat-reduction device of choice and the one that she has been using for about five years is CoolSculpting (Zeltiq).

The ultrasonic destruction of fat cells with UltraShape is another option. Dr. Cox did the clinical trials for UltraShape but doesn’t own the device.

“The company typically recommends three treatments to get the result that is expected or anticipated by the patient,” Dr. Cox says. “What I was seeing during the clinical trials was that it may have not been quite as predictable as what I see with the CoolSculpting, which is typically just one or two treatments for a very defined 20 percent to 25 percent reduction of fat. I can also tell you in terms of studies out there, CoolSculpting for noninvasive fat reduction really does have the most.”

Other options: Vanquish (BTL Aesthetics), a radiofrequency device for fat reduction, and the other ultrasonic device Liposonix (Valeant).

“I had the Liposonix done on my lower abdomen once and didn’t even finish the procedure it was so uncomfortable. And I was not overly impressed with the results that I was seeing in the clinical trials,” Dr. Cox says. “I had the CoolSculpting done on my lower abdomen once and upper abdomen twice with no discomfort.”

The new device on the block is SculpSure (Cynosure), which is a noninvasive laser.

“It’s a 1060 nm wavelength laser that is attracted to fat as its chromophore,” Dr. Cox says.

Dr. Cox says she thinks all these devices are good, but some work better than others.

“Some of them require more sessions, like the UltraShape or Vanquish. Even the SculpSure requires more than one treatment. When CoolSculpting first came out, they talked about it being a one and done thing, but over the years have adjusted expectations by saying there’s a ‘treatment to transformation,’ meaning that you treat an area and you’re going to get 20 to 25 percent reduction in fat. But you may want to treat it again, to get another 20 to 25 percent reduction, or work areas that are adjacent to the areas that you’ve already worked on, so you’re truly sculpting these patients,” Dr. Cox says.

Liposuction still hard to beat (track record-wise)

Though she says these numbers might have since changed, Dr. Cox did a PubMed data search in October 2015 and found there were 50 peer-reviewed articles on CoolSculpting; 37 for Liposonix; 18 for UltraShape; 16 for Vanquish; and eight for Kybella. Cynosure’s website lists three paper presented at American Society for Laser Medicine and Surgery meetings but no published articles in the peer-reviewed literature.

“But if we compare published studies to liposuction, liposuction has over 1,190 peer-reviewed articles. So, liposuction still may be the gold standard, even though that’s not what patients appear to be as interested in because it’s invasive and there’s downtime,” Dr. Cox says.

While liposuction’s appeal might wane in light of new technologies, patients who do opt for the old standby fat removal approach are generally as happy as or happier than those who have noninvasive options.

“If you look at RealSelf, and I pulled the data from 2015 and 2016, it’s across the board in terms of people saying they’re really happy with [liposuction],” Dr. Cox says. “Typically, liposuction has one of the highest ‘Worth It’ ratings and number of reviews,” she says.

For example, at last glance (December 5, 2016), liposuction had 4,561 RealSelf reviews and a 91 percent Worth It rating; UltraShape had 115 reviews and an 87 percent Worth It rating. For CoolSculpting, there were 2,630 reviews and an 83 percent Worth It rating. And Kybella had 279 reviews and 87 percent Worth It rating.

“But I do think that patients are happy with the noninvasive technology. It is pretty easy with the CoolSculpting. The nice thing is they’ve updated the device, so there is a 35-minute cycle time, as opposed to an hour. From the standpoints of patient ease and satisfaction, it’s great,” Dr. Cox says. “In terms of patients being able to return to work with any of these noninvasive devices, it’s pretty immediate. The next day, they can go back to exercising; they can go back to work. There’s really no downtime, with the exception of maybe some temporary numbness or tingling sensation.”

But patients might need multiple sessions with noninvasive devices, whereas, it’s one treatment and done with liposuction, Dr. Cox says.

“You can do several areas at once and have one downtime, one procedure, one expense,” she says.

Dr. Cox says her colleagues that offer fat reduction and removal should keep in mind that the noninvasive are becoming more and more of a commodity offered at salons, medi spas and more.

“There’s a spot near me that was only doing laser hair removal until about six months ago. Now they’re doing CoolSculpting. That’s an issue,” she says.

Making choices

Dr. Cox says colleagues should learn before they purchase or rent one of these devices.

“Definitely look at the peer-reviewed data,” she says. “That’s why I chose CoolSculpting. There is a lot of data to show it is predictable—that it results in 20 to 25 percent reduction in fat every time you’re hooked up to the device. There was recent information where there was 30 percent reduction with UltraShape, and maybe that’s 30 percent because you have to do it three times. You have to look at all this information critically,” she says.

Dermatologists who don’t hop on the noninvasive fat reduction train might miss opportunities for new patients, Dr. Cox says.

“If you don’t have the noninvasive technology, patients aren’t as likely to be driven to your door. They’re drawn to your office by what they see online or on billboards. If you don’t have the noninvasive technology, they’re less likely to come to your office and they may be a better candidate for liposuction but you might not even get to see them,” she says.

The field for noninvasive fat reduction is burgeoning.

“The demand is so high. Patients calling the office. Who doesn’t have a bulge they’d like to get better?” Dr. Cox says.

Disclosure: Dr. Cox did clinical trials for Liposonix (Valeant Pharmaceuticals), UltraShape (Syneron Candela) and Kybella (deoxycholic acid, Allergan). She is a consultant for Merz.