News and Updates: March/April 2021

First, Do No Harm: American Board of Cosmetic Surgery Announces New Cosmetic Surgery Patient Safety Certification Program

The American Board of Cosmetic Surgery is now encouraging members to earn their Cosmetic Surgery Patient Safety (CSPS) certification.

“While all of our board-certified cosmetic surgeons are already required to understand and meet high safety standards, this added credential shows patients the surgeon has gone above and beyond in prioritizing safety matters,” explains Wilbur Hah, MD, Texas cosmetic surgeon and president of the Board, in a news release.

To display the Cosmetic Surgery Patient Safety badge, cosmetic surgeons must pass a specialized, in-depth patient safety exam in addition to the fellowship training and exams they completed to become a board certified. The CSPS logo is intended to reassure patients that not only is their surgeon highly trained in cosmetic procedures: they are also up to date on the latest research-driven best practices for patient safety.

“Choosing a board-certified cosmetic surgeon with extensive experience, the highest level of training, and very safe practices is within reach. Once patients realize that, they will settle for nothing less,” Dr. Hah says.

Clear Face Masks Boost Patient Communication

New research finds doctors who wear transparent face masks greatly improve communication with patients compared to doctors whose faces are blocked by a standard face masks.

Providers who wore the ClearMask are also perceived as having more empathy and elicit greater trust from patients, according to a study in JAMA Surgery.

Researchers conducted a randomized clinical trial of 200 patients, in which surgeons wore either a ClearMask transparent mask or a standard mask during a new patient visit. After the visit, the patients took a survey to evaluate the mask itself and the surgeon’s communication, empathy, and trust, while answering validated questions from the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS).

Compared to standard masks, patients reported improved communication with the ClearMask, rating their physician significantly higher in providing understandable explanations, demonstrating empathy, and building trust. All of the patients whose provider wore the ClearMask preferred the transparent masks, citing improved provider communication and appreciation for full face visibility.

“The study’s overwhelmingly positive results on improved communication with the ClearMask validated what we knew all along: being able to see each other’s faces is fundamentally human and an integral part of how we connect,” says Allysa Dittmar, President of ClearMask, LLC. “The study’s use of the ClearMask brand and its acceptance into a rigorous journal like the Journal of American Medical Association is a powerful testament to the importance of the ClearMask.”

“Trust is the cornerstone of surgical care. Without it, patients would not let us operate on them or trust our judgment to forgo surgery. And how we speak may be more important than what we say,” wrote Drs. Margaret Schwarze and Elle Kalbfell of the University of Wisconsin-Madison in an invited commentary to the study. “As surgeons, we do many bold things because they improve patient care, and wearing a clear mask with new patients should be one of them.”

Solta Rolls Out Next Generation Clear + Brilliant Laser

Solta Medical is launching Clear + Brilliant Touch laser, the company’s next generation Clear + Brilliant laser.

By seamlessly switching between two wavelengths with the Original and Perméa handpieces, physicians can now more easily deliver a more complete treatment during a single appointment.

“As pioneers in the aesthetic market, Solta Medical has continued to evolve the Clear + Brilliant technology to improve upon the ease of use and convenience that physicians and their patients have come to expect from the system,” says Liz Panzica Newman, general manager, North America, Solta Medical, in a news release. “The new Clear + Brilliant Touch laser, which provides aesthetic providers with flexibility to use both the Original and Perméa handpieces seamlessly in one appointment, offers an exceptional user experience to address and deliver on each patient’s individual needs. We look forward to seeing the difference a Clear + Brilliant Touch laser can make for physicians.”

In addition to offering easy access to both the Original and Perméa handpieces in the compact system, the Clear + Brilliant Touch laser also includes a user-friendly touchscreen, a simple training mode to simulate treatment without emitting laser energy and a smart charting assistant that automatically tracks treatment progress with the ability to export patient treatment charts.

“The Clear + Brilliant laser is an easy-to-use and transportable system that has been a mainstay in my practice for years. The new system, the Clear + Brilliant® Touch laser offers even more versatility, for my patients. Having the option to use both wavelengths seamlessly during one appointment will be a welcome addition to my practice and to my patients,” adds Jeffrey S. Dover, MD, FRCPC, a dermatologist in Boston.

Take Five: Eirion’s Jon Edelson, MD

If you haven’t heard of Eirion Therapeutics yet, you will. That’s a promise. Headquartered in Woburn, MA, the aesthetic dermatology company boasts a disruptive pipeline focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair graying and just scored some major financing. Jon Edelson, MD, Eirion’s Chairman, CEO, and President, talked to Modern Aesthetics® magazine about what we can expect in the coming weeks, months and years.

1. Money talks

“Eirion Therapeutics, Inc. recently closed a $40 million Series A investment and licensing deal with Shanghai Haohai Biological Technology Ltd. The deal will result in a $32 million Series A Preferred Stock investment into Eirion along with exclusive licenses that will be for all of Eirion’s products for the territory of China in exchange for an upfront payment of $8 million. The deal is structured in segments over the next 18 months. Haohai’s dermal filler products include Hyalumatrix, Matrifill, and Janlane. The companies have signed two product licenses that have the potential in aggregate to provide Eirion approximately $43 million in development fees, $444 million in sales milestones, with significant product royalty rates. One license is for Eirion’s neuromodulator-based product candidates, ET-01 (topical) and AI-09 (injectable) for aesthetic indications; and a second license is for Eirion’s small molecule product candidates, ET-02 (topical) and ET-03 (oral), which are intended for the treatment of hair loss and hair greying. Under the terms of the licenses, the products will be manufactured in the US by Eirion and developed and commercialized by Haohai in China.”

2. A topical toxin, finally?

“The new funding is very exciting and important. It allows us to move our entire pipeline forward starting with our topical neuromodulator (ET-01), which is in Phase 2 trials for smoothing lateral canthal lines. This funding will get us to Phase 2b. Two aspects of this technology are unique. Our topical product is formulated with a patented proprietary nanoemulsion delivery system that allows the product to enter the skin. The skin is preconditioned to create temporary micropores, which further accelerates the delivery. We are creating portals in the skin mechanically that close up after the procedure. These two things together make for a highly different approach. The procedure itself takes five to 10 minutes with no downtime. This will be a paradigm change and has the potential to greatly expand the neuromodulator market. The same technology is being investigated for hyperhidrosis. There is still a significant unmet need here. The current hyperhidrosis treatments all present some challenges. For example, Botox injections require up to 15 needle sticks per underarm. This is painful and time consuming. Our topical product, ET-01, is specifically for underarm hyperhidrosis.”

3. Hair today

“Our treatments, ET-02 and ET-03, target a defect we have identified in stem cells in hair follicles that controls hair growth and hair color. If we reverse this defect or prevent it from emerging, we can affect hair loss and hair graying. Billions of dollars are spent on hair dye each year, most of which goes to covering up grays. There is a tremendous benefit if a pharmaceutical could address this problem. In controlled non-clinical studies of human scalp tissue affected by androgenic alopecia, ET-02 demonstrated approximately twice the hair growth compared to a control treatment over approximately four months. This amounted to approximately three times the hair growth per centimeter seen in minoxidil clinical trials that were 12 months in duration. Eirion plans to launch its first clinical trial of ET-02 in 2022.”

4. Up shot

“All the current neuromodulator injectables have to be reconstituted in a doctor’s office with saline which can be time consuming and inconvenient, compared to off-the-shelf dermal fillers. AI-09, an injectable which is being developed for the treatment of glabellar lines, does not need to be reconstituted. It also has other benefits. There is no albumin, which carries a risk of disease transmission, and it is stable for weeks or months. In contrast, current formulations have a limited shelf life once reconstituted. Eirion plans to file an IND for AI-09 later this year.”

5. Small, but mighty

“Right now we are five-person company, but the new funding will allow us to expand. We have a very capital-efficient model where we outsource most tasks. We have partners who manufacture and test products, and we work with aesthetic practices who do the clinical trials. We invent and direct the processes. We will start to have our research presented on podiums at clinical conferences in the next few years. We already have a distinguished group of advisers including Ken Beer, MD, a dermatologist in West Palm Beach and Jupiter, FL, and Cary, NC-based dermatologist Tim Flynn, MD. For our androgenic alopecia candidate, we are working with Jerry Shapiro, MD, a dermatologist in New York City, and Ken Washenik, MD, PhD, President and CMO of Bosley Medical Group in Beverly Hills. In the coming years, I’d like to see all the products on the market improving the quality of life of those who use them.”

Should Daily Almond Consumption Be Part of Your Skincare Recommendations?

Snacking on almonds may help reduce wrinkles and skin pigmentation in postmenopausal women, according to a new Almond Board of California funded study published in Nutrients.

In this six-month randomized controlled trial, 49 healthy postmenopausal women with Fitzpatrick skin type I or II were randomly assigned to eat almonds as a snack, which accounted for 20 percent of their total daily calorie intake, or 340 calories per day on average (about two one-ounce servings) or a calorie-matched snack that also accounted for 20 percent of calories such as a fig bar, granola bar or pretzels. Aside from these snacks, study participants ate their regular diets and did not eat any nuts or nut-containing products.

Skin assessments were made at the start of the study, and at eight weeks, 16 weeks, and 24 weeks. At each of these visits, facial wrinkles and facial pigment intensity were assessed using high-resolution facial imaging and validated 3-D facial modeling and measurement. Skin hydration, transepidermal water loss (TEWL) and sebum excretion were also assessed.

There was a statistically significant reduction in wrinkle severity in the group consuming almonds. At 16 weeks, there was a reduction of 15 percent and at 24 weeks, a reduction of 16 percent, the study showed.

There was also a 20 percent reduction in overall facial pigment intensity in the almond group by week 16 that remained at week 24. Further, body weight remained constant for both the almond group and the control group from baseline to 24 weeks.

“Daily consumption of almonds may be an effective means of improving the appearance of facial wrinkles and skin tone (indicated by decreased pigment intensity) among postmenopausal women with Fitzpatrick skin types I and II. Consumers may describe this reduced pigmentation effect as having a more even skin tone,” says study author Raja Sivamani, MD, a dermatologist at the University of California-Davis.

Transepidermal water loss, skin hydration, and sebum excretion were measured on the forehead and cheeks in both groups during the study:

• There were no changes in transepidermal water loss at any time point among the almond and control groups.
• At the end of the study, there were increases in skin hydration among both groups.
• Looking at the sebum excretion rate, both groups showed an increase in the cheeks, but only those in the control group showed an increase in the forehead area.

“Our findings emphasize the need to look at almonds as a whole food with multiple nutrient components including alpha-tocopherol (vitamin E) and good unsaturated fats, rather than oversimplifying potential benefits due to one nutrient alone. Almonds are high in alpha-tocopherol, which has antioxidant functions and may be partially responsible for the effects that we see in both wrinkles and skin tone in postmenopausal women,” says Dr. Sivamani.

The study had limitations including its duration of 24 weeks. Results do not provide insight into the potential effects of longer-term almond intake. Additionally, the study participants were postmenopausal women with Fitzpatrick skin types I and II. More research is warranted to investigate the impact of almond consumption in other populations. And, although the snacks in both groups were calorie-matched, they were not macronutrient-matched.

My New Favorite Thing: Spark
With Dendy Engelman, MD

“I just moved to Shafer Plastic Surgery and the practice is growing by leaps and bounds. As we are interviewing new team members, many of the people we have spoken with have told us that the medical aesthetics industry is hard to break into and that they would love if there was a centralized area for introductory information and some educational materials.

That’s really why I think Spark (YourSpark.com) by Allergan Aesthetics is a great resource for the industry. It’s perfect for anyone (particularly health care providers) looking for more information on medical aesthetics including an introduction to common procedures, advice from aesthetic veterans on how to get started, a list of professional societies dedicated to the education and advancement of medical aesthetics and training via a primer on facial anatomy and facial aging, plus more.

What I like about Spark specifically is that it’s just an initial starting point for the industry and isn’t trying to replicate/short-cut around the training, licensing and certifications required to provide excellent patient care. It’s actually showing some insight into the steps advised. I’m going to recommend it to my practice staff for some introductory information and even read it myself to see what insights my peers are sharing on the website.”

Dendy Engelman, MD
Director, Dermatology and Laser Medicine, Shafer Clinic, New York City

Evolus’ Jeuveau Can Stay on US Market

AbbVie, Evolus, and Medytox have agreed to new settlement agreements to fully resolve all outstanding litigation, including the US International Trade Commission (ITC) case regarding the sale of Jeuveau®, between the companies. A California court case filed by Medytox against Evolus will be dismissed.

Under terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox’s trade secrets and grant a license to Evolus to continue to commercialize Jeuveau in the US and Nuceiva in all other territories in which Evolus has licensing rights. AbbVie and Medytox will receive milestone and royalty payments from Evolus. In addition, Evolus will issue common stock to Medytox.

This agreement follows the final determination of the ITC on December 16, 2020 which found a misappropriation of Medytox’s manufacturing trade secrets and strain of C. botulinum and concluded that a violation of Section 337 of the Tariff Act of 1930 had occurred. As Daewoong Pharmaceutical Co. Ltd. is not a party to the settlement agreements, this settlement does not affect any legal rights, positions, or proceedings between Medytox and Daewoong in Korea and other countries.

Can Fat Grafting Improve Radiation-induced Skin Injury in Cancer Patients?

As cancer survival rates improve, more people are living with the aftereffects of cancer treatment including chronic radiation-induced skin injury.

Fat grafting procedures may unleash the healing and regenerative power of the body’s natural adipose stem cells (ASCs). “Preliminary evidence suggests that fat grafting can make skin feel and look healthier, restore lost soft tissue volume, and help alleviate pain and fibrosis in patients with radiation-induced skin injury after cancer treatment,” says J. Peter Rubin, MD, MBA, FACS, American Society of Plastic Surgeons (ASPS) President-Elect and Chair of the Department of Plastic Surgery at University of Pittsburgh Medical Center. He is one of the authors of a new review of the clinical evidence on fat grafting for radiation-induced skin and soft tissue injury.

“But while promising, available research has some key weaknesses that make it difficult for us to determine the true benefits of fat grafting right now,” Dr. Rubin adds. The review appears in the April issue of Plastic and Reconstructive Surgery.

More than half of patients diagnosed with cancer receive radiation therapy. Because skin cells turn over rapidly, they are exquisitely sensitive to the damaging effects of radiation. In the first few months after treatment, many patients develop acute radiation injury with skin inflammation, peeling, swelling, pain and itching. In most cases, symptoms resolve over time. However, if inflammation continues, radiation-induced skin injury can become a chronic problem leading to tight, fibrosis with a risk of poor wound healing, ulcers, and tissue loss.

In their review, Dr. Rubin and colleagues round up promising research on fat grafting for patients with radiation-induced skin injury.

In studies of breast cancer patients, fat grafting procedures have reduced pain and other symptoms of radiation-induced skin injury—backed up by more-normal cellular appearance of skin cells under the microscope. In other studies, fat grafting has led to reduced risks and better outcomes of breast reconstruction after mastectomy.

For patients with radiation-induced skin injury after treatment for head and neck cancer, fat grafting has led to improvements in voice, breathing, swallowing, and movement. Good outcomes have also been reported in patients with radiation-induced skin injury in the area around the eye or in the limbs.

“The good news is fat grafting has the potential to really help patients with discomfort and disability caused by radiation-induced skin damage,” according to Dr. Rubin. While research is ongoing, the benefits of fat grafting seem to result from the wide-ranging effects of ASCs—including anti-scarring, antioxidant, immune-modulating, regenerative, and other actions.

The reviewers outline some steps for further research to clarify the benefits of fat grafting for radiation-induced skin and soft issue injury, including approaches to clinical assessment and imaging studies, testing of skin biomechanics and circulation, and cellular-level analyses. For all of these outcomes, standardized measures are needed to achieve more comparable results between studies.

“We hope our review will inform efforts to establish the benefits of specific types of fat grafting procedures in specific groups of patients,” says Dr. Rubin. “To do that, we’ll need studies including larger numbers of patients, adequate control groups, and consistent use of objective outcome measures.”

Journey Medical to Acquire Dermira’s Qbrexza

Journey Medical Corporation, a partner company of Fortress Biotech, Inc., has entered into a definitive agreement to acquire Qbrexza (glycopyrronium) in the US from Dermira, Inc., a wholly-owned subsidiary of Eli Lilly and Company.

The transaction is expected to close early in the second quarter of this year. Qbrexza generated $24 million in net sales in the US in 2020.

Qbrexza is FDA approved for treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages nine-years and older) and is self-administered by patients.

Claude Maraoui, President and Chief Executive Officer of Journey Medical, says, “We are thrilled to expand our footprint in dermatology with the addition of Qbrexza to our growing portfolio of prescription dermatology brands. Acquiring Qbrexza will allow us to provide an accessible and convenient product to the millions of Americans who seek relief from excessive underarm sweating, many of whom remain undiagnosed and untreated.”

In two key pivotal trials within adult and pediatric patients with primary axillary hyperhidrosis, use of Qbrexza resulted in clinically meaningful improvements in gravimetrically measured sweat production and disease severity, as measured by the Axillary Sweating Daily Diary, which was a validated, disease-specific patient-reported outcome developed in consultation with the FDA. The safety and efficacy of Qbrexza have been established in clinical trials with treatment for up to 48 weeks.