In the Asia-Pacific (APAC) region, the medical aesthetic market continues to grow faster than any other area in the world. Throughout the region, and especially in China with the rise of its wealthy middle class, people have grown more aware of beauty issues, becoming well-informed about aesthetic treatments via the Internet and social media, and actively seeking out procedures. Meanwhile, the physician’s armamentarium has similarly expanded to include non- and minimally invasive solutions that appeal to more people.

According to the American Society for Aesthetic Plastic Surgery, global cosmetic procedures have expanded by nearly 40% over the past five years, with non-surgical procedures increasing in popularity.

“China is the biggest booming market,” stated William T. Kelley, a global business consultant and former vice president of Europe, Middle East & Africa at Cynosure, Inc.

“While Korea has always adapted new technologies quicker than anywhere else, and this is still the case, China and Taiwan are currently the biggest markets, and Thailand and Singapore have emerged as growing secondary sectors,” he stated.

The market is definitely still expanding, agreed Michael Rich, M.B.B.S., F.A.C.D., A.C.C.S., a dermatologist and founder-director of the Enrich Clinic (Melbourne, Australia).

“More patients of all ages are seeking cosmetic treatments. Their aim, both young and old, is not so much to look younger, but to look better,” he indicated. “No doubt, people are seeking treatments and trying to achieve their benefits with minimal or no downtime, accepting the fact that the results may not be as significant as surgery or other solutions.”

In the past, Thailand, the Philippines and Singapore were never significant business opportunities for manufacturers and developers, noted Barry Rigby, vice president of international sales at Thermi (Singapore). “However, we’ve seen good growth in all countries, including Vietnam, the Philippines and Indonesia,” he pointed out.

“Also, there is a lot more activity in Australia and New Zealand these days,” Mr. Rigby continued. “Thailand is especially active now, too. While India has become kind of isolated from the rest of Asia, it is also a huge market.”

Japan stands somewhat apart from the crowd, Mr. Kelley noted. “It has always been a very conservative market, and even the number of early adopters in Japan is very small compared with the other, larger markets in Asia. Thus, it is growing more slowly,” he said.

Despite the market differences among APAC nations, their populations all want to address the same basic indications. “Therapies focused on pigmentary problems and skin lightening procedures are still big business in this region,” noted Michael H. Gold, M.D., F.A.A.D., a dermatologist and medical director of Gold Skin Care Center and the Tennessee Clinical Research Center in Nashville, Tennessee, U.S.

“The biggest thing in Asia is skin,” Mr. Kelley reiterated. “Asian skin types have a lot of problems with melasma and pigmentary issues. They are also lining up at clinics and hospitals to eliminate hypopigmented blotches and to whiten the skin.”

Increasingly, practitioners are solving pigmentary problems using energy-based modalities, stated Dr. Rich. “In particular, the use of picosecond lasers is becoming more sophisticated, in which its various wavelengths – such as 532 nm, 1064 nm and 755 nm – and the fractional modes are better utilized. When used in tandem with vascular lasers, depigmenting topical preparations and tranexamic acid, results should significantly improve.”

Lasers are also a go-to treatment for addressing depigmented scars, which have been problematic in the past, but show better results when treated with fractional CO₂, Dr. Rich continued. “The laser stimulates melanin production deep within the depigmented scars. Cell cultures can be used to improve the outcome, as well.”

One such example is the SmartXide system from DEKA M.E.L.A. S.r.l. (Calenzano, Italy), SmartXide2 DOT/RF, provides different pulse shapes that accommodate a variety of indications. In addition to providing both CO₂ and radiofrequency (RF)-based technology, this system allows full parameter control (ablation, thermal zone, erythema), giving physicians the ability to tailor treatments for any patient.

The best aesthetic outcomes are often achieved through the use of different modalities in tandem. For instance, a popular treatment for acne scarring and pigmentation following trauma is the application of RF-based microneedling with glycolic acid peels and light-emitting diodes (LEDs).

“Microneedling treatments are very effective for skin rejuvenation and scar treatments,” noted Dr. Rich. “The addition of RF energy to microneedling has benefits that many regard as superior, resulting in significant benefits without significant downtime.”

Microneedling is frequently used to deliver serums on or just beneath the surface of the skin, stated Victor Liu, M.D., a plastic surgeon in San Francisco, California, U.S.

RELATED: Microneedling versus laser: Is one better than the other? 

“Even though the needles don’t go very deep, microneedling has its place,” he noted. “A lot of people use it, for instance, to drive hyaluronic acid, PRP and medications into the skin. The good thing about microneedling is that you can delegate its use to an aesthetician.”

Among new, cutting edge serums coming out, NCTF® BOOST 135HA from Laboratories FILLMED by Filorga (Paris, France) is a distinctive anti-aging, poly-revitalizing solution that nourishes the skin by creating an optimal environment for fibroblasts, which are responsible for the production of the body’s collagen, elastin and hyaluronic acid (HA). The product’s formula combines HA and a proprietary complex of more than 50 active ingredients, including vitamins, minerals, amino acids, coenzymes and antioxidants.

The combining of modalities in parallel to achieve a particular therapeutic result will continue as a strong trend, noted Dr. Rich.

“Other examples include the use of liposculpture for body contouring through the removal and reshaping of fat deposits, followed by skin tightening procedures, which we do because many times removing the fat does not result in a level of retraction that totally satisfies the patient,” he said.

Energy-based skin tightening is very popular throughout Asia-Pacific. Making inroads here are the latest high-intensity focused ultrasound (HIFU)-based devices, which deliver concentrated energy to multiple layers of tissue, to tighten the skin and remove stubborn fat without affecting surrounding areas.

“While body contouring and fat reduction procedures are popular, I do observe more injectables business than ever before,” said Dr. Gold.

“From an aesthetic company point of view, there are more players in the region now. Allergan is operating in China in a big way, and other filler and neurotoxin companies are waiting to obtain regulatory approvals,” he indicated. “In particular, European injectables companies are ramping up their business throughout Asia, in order to grow their footprint beyond Europe where this business has been going flat.”

The demand for non-surgical facial rejuvenation (via dermal fillers and neurotoxins) and skin tightening treatments increases as people grow older. With more than one-quarter of its residents over the age of 65, Japan has the oldest population in the world. And as reported by the U.N., China’s aging population is on track to double over the next 20 years.

And although surgical solutions are required for some therapies, non-surgical procedures are becoming more widespread across APAC. Led by patient demand, more Asian physicians have adopted non-invasive variations on common surgical treatments, such as performing a rhinoplasty using just fillers.

Another example is the V-shaped face, in which chin surgery is combined with jaw surgery to create a more feminine jawline and achieve a more balanced overall look. “A less invasive option would combine botulinum toxin with fillers to the chin,” noted Dr. Rich.

Compared with other methods, thread lifting procedures and facelifts utilizing sutures are less widespread in Asia, but are emerging as a more common option to the surgical facelift.

Among patients of all ages, the once much-publicized trend of Asian women desiring to achieve a “Western look” has mostly sputtered. “That phenomenon has always existed, but I wouldn’t say it is growing,” stated Mr. Kelley. “It is like hair removal, which is a good, stable market, but not growing.”

In terms of the most popular cosmetic surgery procedures in APAC, blepharoplasty remains a top choice among both men and women. East Asian blepharoplasty, or double eyelid surgery, is uniquely popular among some Asian people. This surgery creates a supratarsal epicanthic fold in the patient’s upper eyelid, changing the look of the upper eyelid that extends to the inner corner of the eye.

Aside from blepharoplasty, nose reconstruction and chin alteration are popular facial procedures across China, Japan and Korea. Jawline slimming and strengthening are among the most desired procedures for both men and women.

One of the more unique procedures reported is head shaping, introduced in 2017 in Korea, which involves surgically reshaping the head.

The new health and wellness mindset also includes new regenerative-type concepts and therapies, most of which are experimental but show anecdotal success, noted Dr. Liu. “The development of stem cells for use in skin and facial rejuvenation is very promising because the stem cells can actually regenerate what is lost. In the past, what we did was fill a depression in the face with some fat or fillers. With stem cell-based facial treatments, to our surprise, the depression becomes more than just filled up; the skin is literally renewed and looks much better,” he said.

Another example is the addition of platelet-rich plasma (PRP) treatments with male hormones and other drugs, such as spironolactone and minoxidil for hair loss, said Dr. Rich. “Additionally, finasteride is now given to male and female patients to increase the benefits of treatment.”

Feminine rejuvenation is another big trend right now, expressed Dr. Liu. “Consumers are aware of the new energy-based feminine rejuvenation approaches available, and now there is a huge increase in that field.

“In male patients we know erectile dysfunction and impotence affects 50% of those over 50,” he continued. “An emerging treatment trend is the use of shockwave therapy, and many times that helps. All of these procedures fall into the area of male and female health and wellness, and more aesthetic specialists are getting involved in that field.”

Putting aside the trends of the future and focusing on the current state of the industry, governing bodies in the APAC region, notably China, have recently stepped up efforts to better regulate medical devices and other aesthetic products, such as fillers and neurotoxins.

According to Mr. Rigby, “The regulatory timeline in China is now actually quite long, around three years. They closed some loopholes, too. For many years there was sort of a gray area, in which a manufacturer could enter the spa market with lower powered products. They did that because they were having a hard time obtaining regulatory approval. Today, everybody has to get the proper regulatory approvals.”

With the regulatory environment normalizing, an educated middle class population clamoring for aesthetic treatments, and sustained economic growth, the APAC region has become a mecca of anti-aging solutions.

“There is so much going on in Asia it is hard to wrap your head around it all,” said Dr. Gold. “Right now, however, we are seeing a lot of interest among dermatologists and plastic surgeons in the region, and I see that the market will keep expanding exponentially. The sky is the limit.”

Cosmetic products with prebiotics, probiotics and postbiotics may be beneficial in treating eczema, a physician reported at the Fall Clinical Dermatology Conference held earlier this month in Las Vegas.

“Cosmetic products contain preservatives that prevent bacterial contamination. Because of that, it is not possible to have live bacteria in skincare products,” said Joshua Zeichner, M.D., director of cosmetic and clinical research at Mount Sinai Hospital’s department of dermatology. “Instead of true probiotics, products contain prebiotics, probiotic extract or postbiotics. We have data showing that these products are beneficial in treating eczema.”

However, there is not enough data to show if probiotic skin care is more effective than traditional skin care products that don’t contain probiotic ingredients, he said.

• Prebiotics are high-fiber food for live bacteria.
• Probiotic extract is the non-living bacterial lysate along with the medium in which it grew or fermented, that contains beneficial byproducts.
• Postbiotics is a relatively new term that refers to soluble metabolic byproducts of probiotic bacteria, short chain fatty acids and enzymes that are released after bacterial lysis or secreted by live bacteria. Postbiotics have antioxidant and anti-inflammatory properties that may help improve physiological functions.

The three types are derived from the gut, skin, soil or water. Dr. Zeichner shared findings from evaluations of different prebiotics present in thermal spring water and colloidal oatmeal, as treatments for atopic dermatitis.

THERMAL SPRING WATER AND ECZEMA

He studied two thermal spring water products from France, La Roche-Posay and Eau Thermale Avene. He found Posay contains high levels of selenium, which has been shown to have probiotic benefits.

Selenium has anti-inflammatory properties, mitigates lipid peroxidation, and protects against UV-B induced skin damage. It can enhance microbial diversity in the skin and clinically improve eczema, he said. 

Avene contains an extract from aquaphilus dolomiae bacteria which has been shown to have anti-inflammatory properties and can reduce itching. Previous studies have shown that it is effective for eczema, and Dr. Zeichner cited a more recent in-vitro model study that evaluated ES0, a biological extract of aquaphilus dolomiae, for its anti-inflammatory, antipruritic, and immunomodulatory properties. The study concluded that these properties make the bacteria potentially valuable as an ingredient in topical preparations to treat eczema.

COLLOIDAL OATMEAL, A PREBIOTIC
Colloidal oatmeal contains proteins, vitamins B and E, lipids and polysaccharides, and has anti-inflammatory and antioxidant properties.

“Colloidal oatmeal has long been recognized as a skin protectant and it’s included on the FDA monograph to treat eczema,” Dr. Zeichner said. “We are now gaining a greater understanding of how it works.”

It has been widely accepted as a prebiotic for gut health, but data suggests benefits for the skin too. It can increase skin hydration, decrease skin pH, and improve microbial diversity. In addition to anti-inflammatory and skin soothing properties, colloidal oatmeal exhibits prebiotic benefits to enhance growth of healthy bacteria on the skin.

He summed up the main takeaway clinicians need to keep in mind about beneficial bacteria for skin care.

“We know that a diverse microbiome is associated with skin health, and overgrowth of abnormal bacteria is associated with skin disease,” Zeichner said. “Addressing the microbiome is an important part of treating skin disease, along with traditional moisturizers and anti-inflammatory products.”

REFERENCE

Zeichner, J. 2018. Fall Clinical Dermatology Conference, Las Vegas. October 18, 2018. Microbiome and the skin

CITATIONS

Aries, MF. Anti-inflammatory and immunomodulatory effects of Aquaphilus dolomiae extract on in vitro models. Dove Medical Press. May 19, 2016.

While nanotechnology use in cosmeceuticals is promising, safety concerns remain about widespread use of “nanocosmeceuticals” for skin, hair, nail and lip care, researchers from India report in a review published earlier this year.

That thinking is reflected in the U.S. where large companies in the cosmetics industry have voluntarily agreed not to use nanoparticles in currently marketed products because of those safety concerns, according to dermatologist Zoe Diana Draelos, M.D., who practices in High Point, N.C., and founded Dermatology Consulting Services, a company that works with cosmeceutical firms to develop formulations and conduct product testing.

Nanoparticle Safety Concerns

In essence, nanotechnology involves putting particles that are less than 100 nanometers (nm) into a formulation. 

“These are particles of any material,” Dr. Draelos says. “In the cosmeceutical world, typically the nanoparticles would be part of the active agents or the hero ingredient that’s designed to deliver on some cosmetic claim.”

The concern is that nanoparticles are so small that they can penetrate into appendageal structures, like hair follicles. They can the penetrate stratum corneum, theoretically entering the body. 

While safety concerns have kept many cosmetic and cosmeceutical companies from promoting nanotechnology as a benefit, nanoparticles are, in fact, in many of today’s products. Nanoparticles might be an unintentional consequence due to the manufacturing process for raw materials. Dr. Draelos cites the example of titanium dioxide and zinc oxide, which are minerals from rocks ground to a small particle size for topical sunscreens. Grinding  zinc oxide and titanium oxide small enough so applying sunscreen doesn’t make the skin so white might result in creating nanoparticles. 

Another example is in the manufacturing process for cosmetics with pigment, such as eyeshadow, or to make the reflective, frosted, glittery effects of other makeup types. Companies might end up using nanoparticle sized mica or fish scales to create the glittery look, according to Dr. Draelos. 

“Back to the example of zinc oxide and titanium oxide: Imagine if you had nano-sized zinc oxide and titanium dioxide, you could actually get those particles in your skin and they would be there for the rest of your life, unless your immune system phagocytized the material and initiated removal,” she says. 

And it turns out, people are exposed to the unwanted health effects of nanoparticles every day. Nanoparticles are in the byproducts of internal combustion engines and manufacturing processes that involve burning. They’re in pollution. Some are known carcinogens. 

Nanoparticles That Do Good

On the other side of the coin, nanoparticles could do a lot of good. 

“Nanoparticles have very interesting magnetic properties,” Dr. Draelos says. 
Using nanoparticles along with a device with a magnetic field could help target chemotherapy agents to tumor sites, eliminating exposure to the rest of the body, according to Dr. Draelos. 

“Nanoparticles also can have very interesting color and optical qualities. So, nanoparticles because of the way they reflect light, could be used extensively in camouflaging cosmetics,” she says. “Nanoparticles are created with the firing process of ceramics, so there are very old nanoparticles in Egyptian pottery and tile, which gives it a fluorescent look.”

The challenge is developing nanoparticle products that do good, not harm. 

“Let’s say you’ve got nanoparticles in a bottle. In the bottle are also preservatives and emulsifiers. One of the problems is you can’t exactly control what goes in and what doesn’t. You have to make a special formulation so that you’ve eliminated ingredients you would not desire to penetrate the skin,” Dr. Draelos says. “That could become an issue if you use products with nanoparticles in microneedling, dermal rolling, mesotherapy. There you’re making holes and sticking in the product. So this whole issue is very controversial.”

The other hurdle is that nanoparticles, when they’re added to a skincare preparation, tend to stick together, making it unlikely that they’ll actually be small enough to penetrate the skin, according to Dr. Draelos. 

More work needs to be done before dermatologists and others can safely recommend nanoparticle cosmeceuticals to consumers, she says.

Dermatologists who sell cosmeceutical products in their offices have options. Among the popular choices: They can sell already branded lines or brand their own skincare, hair, nail and other products. 

While selling a popular cosmeceutical brand in the office can create a revenue stream for dermatology practices, it’s more likely that practices that have their names — and not another company’s name on those products — will reap other bottom line benefits, like client loyalty, repeat business and greater name recognition, according to Cheryl Whitman, CEO, of the aesthetic business consulting firm Beautiful Forever.

“I feel every dermatologist should have their own brand. They could start out with a hero product — a single product or ingredient they love,” she says. “The margins are amazing on custom branded products and there are several ways to do this. The least expensive option, a white label product is when you put your own name on a product that already exists. Private branded, a slightly more expensive option, is the same but allows you to tweak some formulas. Then there is the more expensive option, taking your products to the next level, where you custom-formulate your own products.”

Having a branded cosmeceutical line can set a practice apart from the competition, Whitman says. Whereas patients might be able to get popular brand names online for less money, they can only buy the branded or customized products from the practices that brand them. And if people have to come back to get more products, it helps with client retention and patient loyalty. 

Patients Perceive Benefit

Building a cosmeceutical brand fills a need for patients. 

“All patients need to buy products. Why not buy it from the doctor, someone they look up to as the authority? If you think in terms of per patient, you’re going to sell between 6 and 12 of the same products per year,” she says. “You’re offering a service by helping patients save time and money by cutting through the clutter of retail shopping while supplying them with high-end efficacious products that you recommend.” 

At the same time, dermatologists shouldn’t promote or create a skin care line just because they think they should. Rather, they should align with cosmeceutical ingredients and products they believe in and that are extensions of services they enjoy performing in practice, according to Whitman. 

A Brand Is As a Brand Does

“You need to have a story. You need to have a mission statement. You need to back up your brand,” Whitman says. “Rather than just making another generic L-ascorbic vitamin C serum, we like to do research with our doctors on key ingredients. We look for new ingredients along with those that are tried and true. We’ll look at what’s going on overseas and in Europe. We also favor products that have testing behind them.”

Whitman says her company recommends testing products before putting them on doctors’ shelves. Before they put their names on products, doctors can test the creams and serums that they plan to sell by having staff, friends, VIP clients and others try them first. 

For the typical high-end cosmeceutical, dermatologists branding those products should pay close attention to how they’re bottled and packaged. 

“Obviously the aesthetics business is very aesthetic-oriented,” Whitman says. “So, if the bottle is really pretty, sleek or has a sexy high-end look to it, you can usually charge more money for it.”

Whitman says she recommends that practices start with selling their branded cosmeceuticals to patients, then go out into the community and beyond. 

“You should have a shopping cart on your website. Designate somebody in your office to be in charge of shipping the product. We actually have concierge VIP doctors who deliver the products to people’s homes, where one of the staff members drop it off,” Whitman says. 

The products should be displayed nicely in the office. Dermatologists can promote their brand by giving out samples at events, creating gift baskets for charities and more. In each case, it’s important to pay attention to how the product looks, she says. 

Dermatologists can also bundle their branded products into services they offer. If they sell facial skin care products, they might bundle a month’s worth into facial laser, microdermabrasion or peel procedures as pre- and post-treatment care. 

A branded cosmeceutical business that starts small can become big, according to Whitman. Some practices are so successful with their branded lines that they patent the formulas and sell them internationally, she says. 

For more on the topic of aesthetic business branding:

On December 12, Whitman is spearheading the day-long “A Branding Facelift: Ensuring Success in Practice Enhancement at Every Angle” preconference workshop at the American Academy of Anti-Aging Medicine (A4M) 2018 World Congress in Las Vegas. Aesthetic Channel readers who use the code BF 2018 can save $100 off the $599 price for registration. For more information, contact Cheryl Whitman at cheryl@beautifulforever.com. To register, click here. 
 

Massive weight loss after bariatric surgery makes the body look thinner and the face look older, according to a study in the October issue of Plastic and Reconstructive Surgery (PRS).

Seven plastic surgeons analyzed photos of 65 bariatric surgery patient faces before and a year after surgery. Patient average perceived facial age before surgery was 40.8 years versus 43.7 years after weight loss surgery. Men older than 40 and people who lost the most weight in the study appeared to age most.

The authors note that compared to an average increase of 16.6 months in perceived facial age after surgery among women, men showed an average increase of 36.2 months. This might be because men are likely to have bariatric surgery when they’re older, with more advanced obesity and more complex comorbidities, the authors suggest.

Age also played a role in the degree of perceived facial aging. While plastic surgeons saw little change among patients younger than 40 years, they reported an average perceived facial aging increase of 34.2 months in those older than 40, which was significant.

The study results support the belief that a sudden change in body weight can cause facial aging, according to perceived age, which is based on the evaluation of others, according to the authors.

Among the study’s limitations: All the patients were Caucasian.

Commenting psychologically on the study, PRS Consulting Editor David B. Sarwer, Ph.D., writes that bariatric surgery holds great promise for many people who are 100 pounds above their recommended body weight. These patients typically lose 25% to 35% of their weight by 18 months post-surgery, according to Dr. Sarwer.

But while patients often emphasize their concerns about physical appearance and body image when considering the surgery, some continue to suffer after surgery from loose, sagging skin.

“In some respects, this finding is not surprising. Loss of facial volume is typically associated with an older-looking appearance,” Dr. Sarwer writes. “If the primary goal of bariatric surgery is to improve morbidity and mortality, with improvements in appearance and body image being secondary, would this information be an important element of the medical decision-making process? The answers to these questions would require further thought.”

Medical aesthetic treatments are on consumers’ minds, with more than a third of U.S. adults considering cosmetic procedures in the next year, according to a new Harris Poll survey done on behalf of RealSelf.

The percentage considering a cosmetic treatment in the next 12 months is even higher, at 49%, for adults younger than 45 years.

"In many ways, younger adults are shifting the way society views cosmetic procedures — they are more open to the idea that beauty is individualized and customizable, and that cosmetic interventions represent their personal choices about their own bodies for their own confidence," Lara Devgan, M.D., MPH, RealSelf chief medical officer and plastic surgeon, said in a company press release.

Among other findings: 80% of Americans say they want to change at least one part of their body, with most targeting their teeth or midsections.

In addition, more people are interested in nonsurgical than surgical procedures.

While confidence boosting is a primary motivator for wanting aesthetic change, work-related reasons are also important reasons why adults are considering one or more procedures. Especially men say they want to appear more youthful for work or to start new jobs.

What’s potentially stopping these people from going ahead with aesthetic procedures? According to the RealSelf Aesthetics Interest Survey, most say treatment costs and fear of complications or bad results are hurdles. Other big concerns include finding the right provider, downtime, fear of looking like they’ve had work done and not being sure about the right treatment options. One in 10 of those surveyed indicated the stigma associated with choosing to have cosmetic surgery was a concern.

RealSelf released the survey results September 26, 2018, which show the top five nonsurgical treatments under consideration are cosmetic dentistry, nonsurgical fat reduction, laser hair removal, facial skin treatments (such as microneedling) and facial and lip filling. The top five surgical procedures being considered are abdominoplasty, liposuction, blepharoplasty, chin or neck lift, with breast augmentation and facelift tied for fifth place. 

Men and women, according to the survey, seem equally interested in having aesthetic treatments in the coming year.

More than 2000 U.S. adults, ages 18 and older participated in the online survey by The Harris Poll from July 10 to 12, 2018, according to RealSelf, an online marketplace for people to learn and share experiences about cosmetic procedures and connect with treatment providers.

Revance is moving ahead on bringing its pipeline neuromodulator daxibotulinumtoxinA for injection (RT002) to market. RT002, a purified botulinum toxin A, is in phase 3 clinical trials for the aesthetic indication of glabellar line treatment.

RT002 features a proprietary peptide technology which binds the botulinum toxin Type A with a stabilizing excipient peptide, which is thought to contribute to RT002’s longer duration of effect, according to company literature. Another distinguishing feature is that RT002 has no animal-derived components or human albumin.

Dermatologist Gary Monheit, M.D., of Birmingham, Ala., led a Revance-funded study and presented “SAKURA 1 and 2 Phase 3 Pivotal Studies DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines,” February 2018 at the IMCAS conference in Paris, France. link: http://www.revance.com/pdfs/Sakura_1_2_TLR_Presentation_at_IMCAS_3_Feb_18_Gary_Monheit.pdf

The two phase three studies are identical in their design to evaluate the safety and efficacy of a single daxibotulinumtoxinA for injection treatment of 40U for the treatment of moderate to severe glabellar lines compared to placebo. The two studies have a total 405 patients randomized to the treatment arm, versus 204 on placebo. The primary endpoint is the proportion of subjects achieving a score of 0 or 1 (none or mild) and an improvement of 2 or more points from baseline on both the Investigator Global Assessment Facial Wrinkle Severity and Patient Facial Wrinkle Severity scales concurrently at week 4.

Approximately 74% of subjects in each of the SAKURA trials met the primary endpoint at week 4, versus 1% or less of placebo. About 70% of subjects were very satisfied in SAKURA 1 and more than 70% were very satisfied in SAKURA 2.

Researchers also evaluated duration of effect and found 35.5% of subjects treated with RT002 in SAKURA 1 and 29.4% in SAKURA 2 achieved a none or mild response on the investigator Global Assessment Facial Wrinkle Severity scale at week 24:

Among the noted adverse events in the treated versus placebo arms: 5.9% to 7% of patients in the treatment arms reported headache, versus 1% to 2.9% in placebo. Eyelid ptosis occurred in 2% to 2.9% of those treated in the two studies, versus none of the placebo subjects. Overall, 17% to 21% of subjects treated experienced treatment-related adverse effects, versus 8% and 10% in the placebo groups.

Revance plans to complete its SAKURA 3 open-label, long-term safety study at the end of this year and if approved by the FDA for glabellar lines expects to launch the product for that indication in 2020, according to the company.

Supervision, delegation and noncompliant ownership are among the hot button issues that can land physicians in big trouble in the medical spa business, according to attorney Renee E. Coover with ByrdAdatto, a law firm specializing in health care and business law.

Coover shares what she says are three high risk areas — supervision, delegation and noncompliant ownership structure — for physicians who own or are medical directors of med spas, and how they can avoid potentially career-damaging liability outcomes.

Supervision and Delegation

Coover highlights two aspects of physician supervision and delegation at med spas. The first, she says, often has to do with noncore cosmetic doctors, including OB/GYNs, emergency room physicians and pediatricians, who become med spa directors or own these facilities.

The problem occurs when these doctors don’t have experience in medical aesthetic treatment.

“To be a supervisor or medical director of a medical spa, it’s really important that the physicians, themselves, have the appropriate experience and training. At the end of the day, if the medical board opens an investigation based on a disgruntled patient, employee or even a vindictive ex-spouse, that physician has to be able to defend himself or herself in front of the medical board as to why certain treatments were performed in the ways that they were. If that physician doesn’t have appropriate training and experience in the medical treatments and services that are being offered at that medical spa, it is not appropriate for the physician to be supervising and delegating those treatments.”

The second key issue is physicians must use practitioners who are authorized in their scope of practice to perform medical treatments being delegated by the physician.

“If you have a physician who is delegating injections to a registered nurse (RN) in a state like Florida where RNs are not authorized to do injections, you could have a real problem,” Coover says.

A physician should ensure that the medical practitioners on staff at the med spa can legally perform the treatments the physician plans to delegate as the medical director.

“This industry has become filled with midlevel providers and, for the most part, they have a lot of autonomy when it comes to performing medical treatments. Physicians don’t necessarily need to be onsite to supervise midlevel providers. But RNs, LPNs [licensed practical nurses], medical assistants and laser technicians require varying levels of physician supervision depending on what state you’re in.”

Physicians can avoid investigations by delegating treatments only to those providers that are authorized to perform the treatments. If they don’t play by these rules, physicians can be charged with aiding and abetting in the unauthorized practice of medicine, putting their and the other providers’ licenses on the line.

Noncompliant ownership structure
The issue of noncompliant ownership structure is state driven. It depends on whether or not a state follows the Corporate Practice of Medicine doctrine, which dictates if medical facilities can be non-physician owned, according to Coover.

But even states that abide by the Corporate Practice of Medicine doctrine might have allowable exceptions.

“In a state that follows the Corporate Practice of Medicine doctrine strictly, that state may say that only physicians can own a practice that provides medical services, which would include a med spa. A handful of states follow the Corporate Practice of Medicine doctrine but have some exception where the physician can own in conjunction with a midlevel provider, like a PA or NP, or there’s a loose interpretation of the Corporate Practice of Medicine and the state may say nonphysicians can own the entity but they cannot employ a physician, they can only contract with a physician,” Coover says. “We’ve seen enforcement arise substantially in this area.”

Coover says a real-life example of how damaging breaking the rules in this area can be is of a recent scenario in which an OB/GYN practiced in a state that required physician ownership of a medical spa. The OB/GYN had no history of reprimand or discipline when she decided to affiliate with a medical spa, where she had been contracted previously to do liposuction.

“She was asked to be the medical director of the med spa but had no ownership,” Coover says. “A patient scheduled a liposuction with her and cancelled that liposuction before the doctor ever saw that patient. The patient asked for a refund. When the medical spa refused to give the person a refund, that potential patient turned in the medical spa to the medical board. They opened an investigation and found the physician was not the owner of the medical spa. They stripped the doctor of her license and reprimanded her. She was reported to the National Practitioner Data Bank. Basically, she was blacklisted. When they reported her to the national data bank, they found that she also had a license in New York as a physician, so, New York opened an investigation on her. That’s still pending.”

This might be a severe example of what can happen to physicians who are involved in med spas that are operating illegally, but it’s reality, according to Coover.

“I think there’s the belief that no one is going to get caught because of the lack of enforcement. That may have been the case five years ago, but now we’re seeing an increase in enforcement,” she says. “It’s really important that physicians look into their state laws and talk to a health care attorney that is well versed in this area before signing on to be medical director.”

Researchers reported in a study published February 1, 2018, in the Journal of Clinical and Aesthetic Dermatology that phototherapy with light emitting diodes (LEDs) can benefit patients with several medical and aesthetic skin conditions — from wounds to aging skin. But while the devices used in physician practices have been associated with a broad range of positive outcomes, home-use devices are different. The authors write that home-use devices deliver much less power “and typically do not have light panel arrays large enough to treat the entire face at once, for example.”

The devices showing the best outcomes, according to the authors, are LEDs with frequencies of 415nm (blue), 633nm (red) and 830nm (infrared).

“In contrast with the medical LED units and their protocols, home use devices have not been validated by controlled clinical studies published in peer-reviewed journals. In some cases, home units may be used adjunctively with dermatologist-provided treatment to address specific areas of concern, but they are dissimilar enough from the medical-grade units to not be considered an alternative to these tested technologies,” they write.

Dermatologist and cosmetic surgeon practicing in Omaha, Neb., Joel Schlessinger, M.D., says he recommends at-home devices as an adjunct to acne treatment and to complement facial rejuvenation regimens. 

“There are many different varieties of light now that are available for skin care devices both in the office and at home. Predominately red light and blue light are the ones that we continue to utilize,” he says. “Blue light devices are generally most effective for acne but they are also currently being looked at for other indications including antiaging. Red light devices have always been the antiaging and calming devices, but these also have some other indications for wound healing and pigmentation.”

He says blue light at-home LED devices are particularly helpful for acne patients who are either uninterested or unable to take standard treatments such as antibiotics or hormonal treatments.

“While these devices aren’t a homerun, they generally do have some benefits for these conditions,” Dr. Schlessinger says.

The jury is out on how effective these devices are for skin aging concerns, but there’s promise and growing consumer demand for devices they can use at home, according to Dr. Schlessinger.
“I think the at-home technologies will be more mainstream for a lot of conditions. It’s a nascent field and we’re still trying to get the full research picture finished, but I’m encouraged that there’s quite a bit of research being done in it,” he says.

For now, Dr. Schlessinger’s top picks that he recommends to patients for at-home use are Quasar MD brand LED devices, as well as NuFace’s red light device, which is on the company’s Trinity unit.

“It all comes down to how many LED sensors there are. The more LED sensors the more likely a device is to succeed,” he says.

Dr. Schlessinger says some are questioning the safety of blue light but more research is needed to draw conclusions about whether blue light is good, bad or somewhere in between. Researchers suggest blue light might be healthy during the day but not so much at night, impacting things like quality of sleep and even causing disease, according to a Harvard Health Letter updated August 13, 2018. 

Microneedling cannot match the tissue-tightening effects of lasers, but it addresses issues ranging from stubborn wrinkles to stretch marks, quickly and cost-effectively, said an expert at  summer Cosmetic Bootcamp held June 21-24 in Aspen, Colorado. Rather than competing, she added, microneedling and laser treatments often complement each other.

Although fractional ablative lasers have bridged the efficacy-versus-downtime gap between traditional CO2 lasers and nonablative lasers, said Tina S. Alster, M.D., no laser can treat severe perioral rhytides successfully. She is director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University in Washington, D.C.

Along with micro-wounding, said Dr. Alster, microneedling creates controlled macro-wounding that spurs healing in the way that tilling a field increases its yield. Microneedling is also inexpensive, combines well with other procedures and incorporates easily into any clinical practice, she said.

Dr. Alster prefers microneedling devices with disposable tips and as many needles as possible. Drum-shaped needle rollers are hard to clean, and their permanent needles dull quickly, she explained.

For perioral rhytides and other indications, Dr. Alster frequently offers what she calls simple microneedling, without radiofrequency assistance, or adjuvant cosmeceuticals delivered through the microscopic channels. Based on a March 2018 Dermatologic Surgery article she co-authored, Dr. Alster offered the following technical tips:

• Don't overdo the gliding gel. "Put just enough on the skin to permit a smooth gliding action of the microneedling tip across the skin, but not so much that excess gel interferes with the device’s motor."
• Use manual traction for smooth needle delivery. "If you're dragging the device over loose skin, the needles can drag or get caught. Your assistant can stretch the skin taut — or you can use your non-dominant hand to do so — during treatment."
• Hold the device perpendicular to the skin so the needles penetrate the surface at 90°.
• Perform multidirectional passes. "I move the microneedling tip back and forth, up and down and diagonally across the treatment area. Some practitioners perform circular motions. It’s important to avoid treatment in the same direction so that patients don’t end up looking like they have stripes."
• Watch for early pinpoint bleeding as a clinical endpoint. “Severely photodamaged skin often bleeds immediately, while fibrotic skin or scars, particularly in non-facial areas, may require several passes to elicit pinpoint bleeding.” Sometimes she treats beyond the pinpoint bleeding, depending on lesional severity. Application of ice water-soaked gauze between passes immediately stops bleeding with minimal pressure. Once bleeding stops, she applies a few drops of Soothe HC Arnica Recovery Balm (A Method).

For patients with minimal perioral rhytides and surrounding photodamage, Dr. Alster frequently performs microneedling followed immediately by full-face nonablative (or, for more extensive photodamage, ablative) fractional resurfacing. To reduce the risk of adverse events, she does not typically perform laser treatment over areas that have been microneedled.  She recommends combination microneedling and nonablative laser treatments at monthly time intervals.

"What I like about this combination is that most patients who undergo treatment on a Friday can return to work or their regular activities on Monday. Any residual post-treatment erythema can be easily covered with makeup as early as one day post-treatment,” she said.

However, applying preservative-containing cosmeceuticals too soon after microneedling or nonablative resurfacing can lead to granulomas. Therefore, Dr. Alster advocates waiting until patients have returned to their regular skincare regimen (usually one week post-treatment) before applying additional cosmeceuticals. During that week, patients use her A Method post-care kit, which includes a gentle, nonirritating cleanser, a daytime moisturizer with a nonchemical sunblock and an evening moisturizer.

For atrophic scars, Dr. Alster said, traditional pulsed CO2 lasers can provide significant and lasting improvements with just one treatment. But to avoid post-treatment mismatches in skin color or texture, laser treatment must be delivered to entire cosmetic units. With microneedling, she said, a small area of atrophic scars within a cosmetic unit can be treated without worrying about color mismatches, provided patients do not have pre-existing dyschromias in that location.

For a patient with hypertrophic scars and keloids resulting from CO2 laser burns created by another practitioner, Dr. Alster initially prescribed topical agents in order to improve her dyschromia. "Then I applied the pulsed dye laser on her erythematous, hypertrophic scars, followed immediately by microneedling." The patient achieved very good results with just one treatment, she said. The same was true for a patient whose upper arm Dr. Alster treated for fibrosis following a motor vehicle accident.

To remove a patient's cosmetic lip tattoo, Dr. Alster used a CO2 laser with a 3mm hand piece, tracing the vermilion border to leach out some of the pigment. "I vaporized the area and had a very good result." These days she also uses microneedling for such patients.

Recently, she performed two sessions of microneedling for a patient who had darkening of a flesh-colored camouflage tattoo in a scar that had received prior treatment with a Q-switched laser. "Not only was marked scar improvement seen, but reduction of the darkened tattoo ink was also apparent," she said.

Dr. Alster added that she loves microneedling for enlarged pores, including those created by skin picking or by applying electrodesiccation for telangiectasias around the nose. "Microneedling disrupts the fibrotic pores and induces new collagen formation." For striae that cover large body areas, she said, microneedling can improve both skin texture and tightness.

For periocular treatment, Dr. Alster prefers lasers because their heat provides immediate skin contraction and long-term collagen regeneration. Laser advantages include a proven track record of safety and efficacy, she said, and better collagen contraction than microneedling provides. Laser drawbacks include the fact that they require more money, space and operator training. And their utility in darker skin types is limited.

Microneedling provides modest skin contraction as a result of the wound-healing cascade, Dr. Alster said, but it creates much more bruising around the eyes than lasers do. "In addition to the fact that periocular skin is thin (and therefore more prone to trauma and bruising), it is more difficult to keep the periocular area taut during microneedling." With all forms of microneedling, she added, results are operator- and patient-dependent.