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New Products, Research and Techniques Further Advance Thriving Facial Injectables Market

New Products, Research and Techniques Further Advance Thriving Facial Injectables Market
Injectables not only propelled aesthetic medicine into the stratosphere due to their relative safety and accessibility, as well as the no-downtime outcomes, they represent an ideal gateway into aesthetic practices. For the most part injectables are easy and safe to use by trained professionals, and because they can be delegated to non- physicians, injectables are a profitable foundation of most aesthetic practices and medspas.

Injectables not only propelled aesthetic medicine into the stratosphere due to their relative safety and accessibility, as well as the no-downtime outcomes, they represent an ideal gateway into aesthetic practices. For the most part injectables are easy and safe to use by trained professionals, and because they can be delegated to non- physicians, injectables are a profitable foundation of most aesthetic practices and medspas. As such, they represent a massive piece of the overall aesthetic market, appealing to patients with more modest means, as well as the wealthy, so their development continues to advance.

Elizabeth B. Houshmand, MD

Elizabeth B. Houshmand, MD Dermatologist
Dallas, TX

John Fezza

John P. Fezza, MD Director of Cosmetic Services Center for Sight
Sarasota, FL

Sheila Barbarino, MD

Sheila Barbarino, MD
Facial Plastic & Cosmetic Surgeon Barbarino Surgical Arts
Austin, TX

Falguni Shah, MD

Falguni Shah, MD Dermatologist
Founder
Radiance Skin Clinic Mumbai, India

emsculpt, emote, btl, electromagnetic, tone, FDA cleared, buttocks, muscle

Brian Kinney, MD Plastic Surgeon Beverly Hills, CA

“It is my privilege to have been able to explore many products available internationally and not yet in the U.S.,” said Elizabeth B. Houshmand, MD, a dermatologist in Dallas, Texas. “I enjoy watching more and more of these become available because they expand our toolbox, giving us more and better options for facial optimization and mitigation of the appearance of aging. Their rheological properties such as G’, viscosity and elasticity help determine how they are best used to help patients achieve their aesthetic goals and feel more confident.

“When you consider the trend toward quick, non- or minimally invasive procedures with minimal downtime and risk, it is obvious why the popularity of injectables continues to grow,” she continued. “The ideal patient is realistic and seeks to look like their best self. They want to be healthy and enjoy life to the fullest. More and more they are taking a preventative approach. For many patients, injectables in combination with devices are increasingly delaying or replacing the scalpel.”

One product holding fast at the edge of the horizon is the Daxi (daxibotulinumtoxinA) neuromodulator from Revance Therapeutics, Inc. (Nashville, Tenn.). “Over the decades I have used every neuromodulator available in the states, and the big thing with Daxi is that the science suggests significant longevity of results,” said John P. Fezza, MD, who practices aesthetic medicine as director of cosmetic services for the Center for Sight (Sarasota, Fla.). “Its FDA approval has been held up by COVID-19 but it is expected to be available very soon.”

Higher durations have also been seen with hyperdilution of currently available neuromodulators, a growing off-label trend that has undergone recent scientific study, according to cosmetic surgeon Sheila Barbarino, MD, of Barbarino Surgical Arts (Austin, Texas). Dr. Barbarino has been involved in the publication of several inject- ables studies during COVID-19, using the time to delve deeper into injectables. One pilot study currently under peer review involves the use of high-dilution incobotu- linumtoxinA for lines of the forehead, glabella and lateral periorbital region, revealing longer duration of outcomes with improve- ment graded by non-treating physicians using a validated scale.

“It was also important that we measured subjective improvement given that patient satisfaction is, perhaps, the most important endpoint other than safety,” she stated. “The goal is to seek a softer look by using a higher dilution to increase spread of the neurotoxin using fewer units. More and more, patients are going for a more natural look where they can maintain some degree of facial expression. We in the community have found that higher dilutions are less wasteful and easier to work with.”

The investigation enrolled women (n=15, 35 to 65 years of age) desiring correction of the upper face, who were treated with hyperdiluted incobotulinumtoxinA. Among the results, for overall appearance, patients were at least ‘improved’ in 100% of cases at the five-month follow-up, and about 75% of cases at six months. “Bear in mind that for those data the sample size was small and graded by the patients themselves,” Dr. Barbarino reported, “but these encouraging results warrant more intensive study with larger patient populations.”

Dr. Fezza was recently part of a select group of core aesthetic physicians in an emergency meeting with the FDA regarding filler complications related to the increased use of fillers and the possibility of intravas- cular injections. “These complications are extremely rare, but the consequences can be serious, such as blindness when this occurs near the eye, or tissue necrosis,” Dr. Fezza indicated. “I shared my expert opinion that dermal fillers are incredibly safe, com- plications are rare and transient, and serious side effects are extremely rare. Careful injection, knowing your anatomy, and being able to gauge tissue response, are the best ways to avoid serious issues. While there has been some science suggesting that the use of a cannula may improve safety, in my experience a skilled injector will have equally good results and low incidence of side effects with cannulas or needles. While I’m not sure where theBefore and after filler in the jawline Photos courtesy of John P. Fezza, MDy are going with these inquiries, the real takeaway is the height- ened awareness of the FDA about fillers and their increased popularity.”

According to dermatologist Falguni Shah, MD, founder of Radiance Skin Clinic in Mumbai, India, the role of anatomy cannot be understated. “As an injectables trainer, this is something we reinforce,” she emphasized. “It is the best way to prevent complications. It is also of great importance to be careful and methodical in your injection technique.” One pro tip: be present for the consultation and pay close attention to the patient’s facial animation, which is revealing. “The goal is to get them animated, talking and smiling, whereby we can observe the movement of the face and make our best determinations about how to maximize the use of our tools to give the patient the result they are seeking. They always come in with one idea in mind, but we must think beyond that so we can advise which tools, in combination, will give them what they are really desiring.”

In addition to the June 2020 FDA clearance of Juvéderm Voluma XC from Allergan Aesthetics (Irvine, Calif.) for the chin, RHA fillers (manufactured by TEOXANE SA and distributed in the U.S. by Revance Therapeutics) are likely to come into their own soon, according to Dr. Fezza. There are four fillers: 2, 3 and 4, which are currently approved, and “1” which is currently emerging from FDA trials. “The 1 is the lightest and, along with the 2, is likely to have successful application in the difficult to treat tear trough area. We are excited to see what it can do.”

Gaining some traction, the use of fillers in the body can be perfectly safe, according to plastic surgeon Brian Kinney, MD (Beverly Hills, Calif.). However, it is not practical in most cases. “It may be useful to study this application of fillers, but we have to consider the overall armamentarium and the dynamic nature of the body, both physically and physiologically, when thinking about using fillers for body contouring,” he explained.

“For one thing, volumization would require large amounts of product, which may be cost prohibitive if you look at what can be done with energy-based devices,” Dr. Kinney continued. “There are a growing number of incredible devices out there that do a better job more easily, with more natural-looking outcomes. That is especially important because the body is always moving, and various forces cause fluctuation of weight and water retention. It may be useful in small areas occasionally but it is largely impractical.”

The filler market is an odd one, according to Dr. Kinney. “I have done a lot of trials with fillers, and one thing that has struck me is how in Europe they have literally hundreds of HA filler options, while in the U.S. we have a manageable handful,” he said. “Are all of these little variations just carving smaller pieces out of the same pie?”

Emerging filler Algeness from Advanced Aesthetic Technologies, Inc. (Brookline, Mass.) may be creating a new pie. Comprised of non-crosslinked agarose polysaccharide polymer, the product is easy to inject but has a high G’ modulus which gives it a more gelatinous consistency. “Basically, this can be used as an injectable implant,” Dr. Kinney said. “Rather than simple volumization, it can hold or be pro- jected into a shape. With HA fillers you can fill a space, but not project over the baseline surface with ease. Also, Algeness is an all-natural, pure algae extract rather than a product of bacterial fermentation so there is no need to filter it or extract proteins.”

Maybe most remarkable is the fact that Algeness is not crosslinked. “If you inject non-crosslinked sugars, including HA, into blood it will dissolve or disperse within a few minutes; if injected suBefore and after one syringe of 3.5% Algeness compound with 0.2 mL lidocaine 2% Photos courtesy of Brian Kinney, MDbcutaneously it will be gone within a few days. We crosslink for duration,” Dr. Kinney began. “The risk is that if injected into a vessel we may see coagulation, even a thromboembolism or granuloma. This is not an issue with Algeness. As a fully-hydrated hydrocolloid it will not absorb water, so its risk of causing a blood vessel blockage has not been seen and should be exceedingly low.”

Furthermore, as Dr. Kinney pointed out, while it cannot be broken down with an agent like hyaluronidase, correction is achieved with simple saline injection. “In short, what we have is an injectable that can realistically create a projec- tion, is incredibly safe, and won’t provoke an allergic reaction because there are no proteins, and it can be corrected with something universally available and cheap. Algeness will revolutionize facial recontouring.”

Also maximizing his forced downtime during COVID-19, Dr. Kinney is co-author on several Algeness trials including a recent random- ized, split-face investigation1 comparing the 2.5% agarose gel product to hyaluronic acid filler for nasolabial folds in which male and female subjects (n=66) were treated.

Improvement with Algeness was shown to last between seven and eight months, with filler longevity between the two products confirmed via ultrasound. Similar patient satisfaction was noted. Adverse events were minimal and transient, with incidence divided similarly between the two products. “Algeness has repeatedly shown itself to be non-inferior to products that may be similarly classified, and safe,” Dr. Kinney reported.

While new techniques and products con- tinue to emerge and evolve, dDay one, two and five after treatment with hyaluronic acid filler using INhance Post-Injection Serumelivering optimal results is evermore. For Dr. Shah, the most natural result with injectables comes from combinations that include fillers and neurotoxin. “One particular technique I have developed is the use of PDO threads to reposition the fat pads combined with neuromodulators to relax the neuromuscular junction,” she shared. “We also augment the result by addressing volume loss with hyaluronic acid fillers, which are the only ones available in India at this time. These three are my main minimally invasive tools, and we will usually use two or all three in combination for the best results to address the signs of aging.”

Dr. Barbarino authored a 2020 pilot study2, in which Dr. Fezza was among the co- authors, examining the combination of inco- botulinumtoxinA and cohesive polydensified matrix hyaluronic acid filler for perioral and periorbital rhytides. This study of women (n=10) with moderate-to-severe lateral periorbital lines and perioral lines involved injection of 10 U of neurotoxin followed by 1 cc to 3 cc of filler to the lines in each area. Patients were graded using validated scales at one, three and six months. At least moderate improvement (75% at least ‘imSTERiGLIDE microcannulas (distirbuted in the U.S. by Air-Tite Products) are designed to maximize the safe, precise delivery of fillersproved’) was seen lasting out to six months. “These areas are key because they are highly mobile regions and among the first to show the signs of aging,” she noted.

Use of injectables may also benefit from the addition of ancillary products designed to enhance treatment. INhance Post-Injection Serum with TriHex Technology® from ALASTIN Skincare, Inc. (Carlsbad, Calif.), is specially designed to work with injectables, such as dermal fillers, to help accelerate recovery from post-injection bruising and swelling, as well as improve the appearance of skin quality and texture by supporting the skin’s natural production of elastin, collagen and hyaluronic acid.

Similarly, STERiGLIDE microcannulas from TSK Laboratory, and distributed in the U.S. by Air-Tite Products Co., Inc. (Virginia Beach, Va.), are designed to maximize the safe, precise delivery of fillers. Made of the highest quality steel, a surface coating is added to reduce friction within soft tissue to improve handling and reduce patient discomfort. The delivery port is nearest to the patented tip, which itself is dome shaped to minimize drag.

“We have all seen a normalization of the use of injectables, and this will continue,” said Dr. Houshmand. “The public understands that if done appropriately, enhancement can be natural-looking, and I’m glad the public is more aware that you can look like yourself not overdone or ‘fake.’ Patients should take careful consideration when choosing their dermatologist because in the end it is the painter, not the paintbrush, that is most important.”

 

References:

1. Scuderi N, Fanelli B, Fino P, Kinney BM. Comparison of 2.5% agarose gel vs hyaluronic acid filler, for the correction of moderate to severe nasolabial folds. J Cosmet Dermatol 2020 Dec; epub ahead of print.

2. Barbarino SC, Woodward JA, Levine J, Fezza J. Evaluating an incobotulinumtoxinA and cohesive polydensified matrix hyaluronic acid filler combination to treat moderate-to-severe periorbital and perioral rhytids. J Cosmet Dermatol 2020 Oct;20(5); 1459-66.

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