Recent Developments

Special Report: The Latest In Lasers and Light-Based Technologies from ASLMS

By Wendy Lewis

The American Society for Laser Medicine and Srugery has concluded another successful program. Dermatologist and leading laser surgeon Eric F. Bernstein, MD, MSE of Ardmore, PA, served as ASLMS President for the year. “It was an absolutely wonderful time connecting with friends and colleagues. There are very few venues where there is such a massive confluence of industry engineers, physicians, other healthcare providers, PhDs, and multi-specialty disciplines.”

According to ASLMS Past President Mathew Avram, MD, Director, MGH Dermatology Laser & Cosmetic Center, Boston, “The meeting was characterized by cutting-edge technologies and treatments that will define the future of energy-based procedures for medical and aesthetic conditions. Treatments as diverse as heating with lidocaine, electromagnetic stimulation, and others were the type of thought-provoking features that continue to make this a must-attend event for those in our field. As always, you will hear about it at ASLMS first!”

Denver dermatologist Joel L. Cohen, MD got to stay in his home town this year. “ASLMS in the Mile High City was fantastic. Folks saw great lectures and were privy to new innovations in technology, as well as learning how to better use things we already own. Sciton launched their new JouleX platform at the most important laser meeting. In my practice, our Sciton technology delivers consistency with full-field and fractionated Erbium resurfacing, minimal downtime with HALO, and pigment correction with BBL. JOULE X is bringing major innovation to the Sciton platform by adding its Clear Suite module for vascular, skin, and hair. These are very exciting additions to an already outstanding platform.”

There was also a lot of excitement around the BTL Aesthetics Emsculpt launch of the newly FDA-approved applicator for treating arms and thighs. Los Angeles plastic surgeon Brian Kinney, MD, leader of the research study group presented some interesting new data. “Our one-year data from CT and MRI shows a slight ongoing improvement in the muscles, with essentially the same results as at one and three months for diastasis and abdominal wall fat thickness. Patients continued with their normal lifestyle and underwent no additional treatments during that time.”

He continued, “The EmSculpt HIFEM technology is backed by research with over 200 patients in a seven-center, blinded study group. Results at various time points—one, two, and six months—were evaluated by blinded radiologists with MRI, CT, and ultrasound. In addition, 2D and 3D photography and tape measurements were taken. Animal studies, biopsies, and chemistry values showed release of free fatty acids, powerful stimulation of the muscles, hyperplasia and hypertrophy of the muscles, as well an increased apoptotic index of adipocytes. New studies presented at ASLMS 2019 confirm improvement in the buttocks. We also look forward to possible FDA clearance for the calves in the near future.”

Among the most popular perennial sessions, this year’s “Ask Me Anything” forum featured Drs. Arielle Kauvar, Brian Zelickson, Roy Geronemus, and Suzanne Kilmer. As always, the Tech Connect program was a full house. Chaired by Hong Kong dermatologist Dr. Henry Chan, the key topics featured included body contouring, vaginal rejuvenation, picosecond and vascular devices, and stimulated a lively debate about what works best and what’s coming next. Key learnings included a discussion of energy-based options for women’s health that concluded with a general consensus that women are seeking out these treatments despite FDA warnings, and the results achieved with current technology can be life changing for patients.

In the vascular category, Cutera introduced their new excelV+. According to Dermatologist Kelly Stankiewicz, MD of Park City, UT, “The excel V+ is a whole new level in vascular and pigmentation treatments. It delivers 50 percent more power in larger spots sizes for much faster treatments. It brings back the beloved Dermastat for precise treatments of smaller lesions and vessels. It includes a novel new laser, the Green Genesis, for gentle yet effective treatment of vascular and pigmentary lesions. It’s the most advanced laser of its kind on the market today.”

Another technology that attracted attention hails from Lutronic. Their Genius system for RF delivery received high marks from presenters for its ability to provide real-time feedback to facilitate customized treatments that are comfortable for patients. There was also some buzz about LaseMD, a Thulium 1927nm system that creates microchannels in the skin to deposit cosmeceuticals, tranexamic acid, resveratrol, vitamins C and A.

Cynosure’s innovative tool, the TempSure Surgical RF system, offers a point of difference and versatility for practitioners of all specialties. “TempSure Surgical allows me to perform superior surgical incisions quickly and with greater precision. It is the ideal choice for cutting and coagulation and is truly a breakthrough technology that has revolutionized my practice,” says Barry Dibernardo, MD, Montclair, NJ plastic surgeon.

Candela Corporation featured their updated pulsed dye laser, the V-Beam Prima. According to Dr. Bernstein, “Prima is the next generation of pulsed dye laser offering two wavelengths, 50 percent greater energy than the previous-generation laser, and dramatically extended dye-life as well as once-a-day calibration. The Prima is often used in combination with the Candela PicoWay Resolve for a one-two punch rejuvenating treatment.”

Dr. Bernstein turned over the reins to incoming ASLMS president, Miami dermatologist Dieter Manstein, MD, PhD.

The 2020 conference will be held at the Phoenix Convention Center in Phoenix, AZ, April 29 - May 3. For information: aslms.org

Study: Burt’s Bees Sensitive Skin Regimen AND Metronidazole Effective for Rosacea

A recent study published in Journal of Drugs in Dermatology and presented at the American Academy of Dermatology Annual Meeting showed clinical improvements in rosacea symptoms and overall skin appearance in minimal to severe rosacea in patients using the Burt’s Bees Sensitive Skin regimen as an adjunct to 0.75% metronidazole. This 10-week, single-site controlled, product-blinded study was conducted in 80 women with facial rosacea requiring prescription medication. They received six weeks of 0.75% metronidazole gel and were then randomized following baseline measures to receive the nature-based regimen or control regimen, twice daily for four weeks in conjunction with the gel.

Blinded investigator global assessment of rosacea, investigator-rated, and subject-rated overall skin appearance was assessed using a 5-point scale (0=none, 4=severe) at baseline, two weeks, and four weeks. Noninvasive skin assessments for skin hydration and skin barrier function were made by corneometry and TEWL, respectively. The Burt’s Bees nature-based regimen resulted in improvement in investigator global assessment of rosacea measures at 4 weeks from baseline (erythema, 28 percent; telangiectasia, 26 percent; papules/pustules, 34percent: P less than 0.001) and the control regimen resulted in a eight to 12 percet improvement. Differences between treatments were statistically significant. Overall skin appearance measured by the investigator was clinically and statistically improved from baseline by 32 percent and 12 percent with the nature-based regimen and control regimen, respectively. Overall skin appearance measured by subjects was improved by both regiments from baseline with no differences between treatments. Both regimens improved barrier function from baseline to week four. No clinically significant tolerability issues were reported in either regimen at week four. The study concluded that the Burt’s Bees Sensitive Skin regiment was effective, well tolerated, and superior to the control regimen in the management of rosacea, concomitantly treated with metronidazole.

Hemali Gunt, PhD, Head of Clinical and Scientific Affairs, at Burt’s Bees, and a co-author on the study with Zoe Draelos, MD and Stanley B. Levy MD says patients want to use natural products, but physicians want data before recommending products to patients. This study gives dermatologists that support so they can have confidence in recommending these products to their patients with rosacea.

Skin Cancer Awareness Month Campaigns

Most Americans aren’t using sun protection as often as they should be—increasing their risk for skin cancer, including melanoma. In fact, just half of Americans always or almost always protect themselves from the sun when they’re outside, according to a new survey by the American Academy of Dermatology.

In recognition of Skin Cancer Awareness Month in May and Melanoma Monday on May 6, the AAD started a campaign to ask consumers, “Do you use protection?” and encouraging the public to “practice safe sun” to protect themselves from skin cancer, which is the most common cancer in the United States. It’s estimated that one in five Americans will develop skin cancer in their lifetime, and even one blistering sunburn during childhood or adolescence can nearly double a person’s chance of developing melanoma, the deadliest form of skin cancer, later in life.

“Nearly 20 Americans die from melanoma every day,” says board-certified dermatologist George J. Hruza, MD, MBA, FAAD, president of the AAD, in a news release. “Exposure to the sun’s harmful UV rays is the most preventable risk factor for skin cancer, and there are many simple things you can do to protect yourself from the sun.”

MoleSafe USA, LLC also launched an interactive, online “Spot the Melanoma Challenge” where participants are presented with the difficulties of detecting skin cancer.

The challenge— www.molesafe.com/melanoma-challenge—is designed to educate the greater community on the importance of regular skin exams and the fact that one in five people will get skin cancer in their lifetime. As a part of the program, participants are placed into a draw to win a $1,000 vacation gift voucher.

Close Up

With Jeffrey Carter, MD

Each year, 250,000 children in the US sustain burns that are serious enough to require medical attention and of these, 15,000 children are hospitalized with burn-related injuries, according to the Burn Foundation. Currently available treatments for burn injuries in pediatric patients such as split-thickness skin graft (STSG) are less than ideal because they pose a significant risk of contracture and the results may not be aesthetically pleasing. Moreover, lack of available donor skin remains a major limitation in achieving permanent closure, and the longer a wound remains open, the more susceptible a patient is to infection. A new donor skin sparing-technology, the RECELL System from Avita Medical, uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in about 30 minutes. The cells are applied in combination with widely meshed split-thickness autografts for definitive closure with minimal donor skin. The system was FDA approved in September 2018 for the treatment of acute thermal burns in patients 18 years and older. Here, Jeffrey Carter, MD, FACS, a burn and trauma surgeon at University Medical Center New Orleans Burn Center and LSU School of Medicine in New Orleans, discusses the results of a new study on the RECELL System in pediatric burn patients that was presented at the American Burn Association (ABA) 51st Annual Meeting in Las Vegas.

Why is this topic important to study?

Jeffrey Carter, MD: Burn injuries are a major source of disability, death, and despair for patients and their families with few major advancements in the last 20 years. Severely burned children are a particularly vulnerable population when you consider the sequela of injury and scarring.

Describe the research and your findings.

Dr. Carter: This was the first analysis where autologous skin cell suspension derived with the RECELL device was applied to children with burn injuries. The study included 23 pediatric patients with a median age of 6.7 who were treated under FDA Investigational Device Exemption (IDE)-approved Compassionate Use and Continued Access programs. A total of 107 burn injuries were treated in the study, and 98 percent achieved definitive healing within four weeks of treatment. Importantly, for patients with greater than 50 percent total body surface area (TBSA) burns, treatment with the combination of Spray-On Skin Cells and widely meshed split-thickness autografts achieved the same high rate of healing at week four as patients with smaller burns (burns equal to or less than 50 percent TBSA) treated with the same combination. In addition, in the study the donor sites on all patients were treated with Spray-On Skin Cells, and 62.5 percent of the donor sites were healed within a week of treatment, and 100% were completely healed within two weeks of treatment. This advancement is important for clinicians in dermatology and burn care because it is the first U.S. analysis where autologous skin cell suspension derived with the RECELL device was applied to children with burn injuries.

What is the next step?

Dr. Carter: RECELL technology holds a lot of potential as we learn more about cellular behavior after application. Functional and aesthetic studies as part of a larger quality of life analysis also hold a lot of promise. Additional areas of interest include treating other forms of cutaneous injuries and/or scars or diseases that result in hypopigmentation.

Crown Laboratories Acquires Keri

Crown Laboratories, Inc. acquired the North American rights for Keri from GlaxoSmithKline (GSK). The acquisition of Keri marks Crown’s sixth product acquisition from GSK in the past five months.

“Acquiring the Keri brand supports Crown’s objective of providing its customers with a broad offering of skin care solutions for every age and skin type,” says Jeff Bedard, Crown’s President and CEO, in a news release. “We approach our business with a cradle-to-grave philosophy. Our product portfolio treats, protects and nourishes skin of all ages. Keri is a welcome addition to every daily skin care regimen.”

Crown also received an equity investment from Greenspring Associates, Inc. Other current equity investors in Crown include Hildred Capital Partners, LLC and Montreux Equity Partners, LLC.

Double-blind, RTC Study Supports Efficacy of Botanicals in Kamedis Formulation

Traditional Chinese botanicals in homeopathic over-the-counter Kamedis Calm Eczema Therapy Cream play a pivotal role in the product’s ability to reduce eczema rashes, according to results of a new study announced by the company.

Results show that commercially available Kamedis cream was 44 percent more effective in treating atopic dermatitis than the Kamedis formula without the botanical extracts. It was also 23 percent more effective than a competitive OTC brand widely used to provide eczema relief.

The double-blind, randomized, controlled study is the first in the US designed to determine the efficacy of traditional Chinese botanicals in commercial dermatologic treatments. The clinical trial involved 108 children and adults from ages 3 to 73 with mild to moderate atopic dermatitis who were randomly divided into three groups of equal size. One group used the Kamedis Calm Eczema Therapy Cream, one used the Kamedis formula without the botanical extracts, and one used a leading third-party OTC product. All three groups used a Kamedis wash for the body and face, followed by one of the three randomized treatment creams for the affected areas on the face and body.

After 28 days, patients treated with the complete, botanically rich Kamedis Calm Eczema Therapy Cream showed a 6.8 percent improvement in rash extent and severity as measured by the Body Surface Area (BSA) score, compared to just 4.7 percent for the Kamedis cream without the botanicals and 5.5 percent for the non-Kamedis product. That represents a 44 percent difference in BSA improvement between the complete Kamedis product and the Kamedis formula without botanicals, and a 23% difference between the complete product and the competitive OTC product.

In addition, clear improvement was visually evident after 28 days of using the Kamedis cream. No adverse events were reported.

Dysport Marks its 10th Year on the US aesthetics Market

Galderma Laboratories’ Dysport (abobotulinumtoxinA) is celebrating 10 years. The company is offering double points for Dysport aesthetic treatments registered in the ASPIRE Rewards program through July 31, 2019. Additionally, in select US markets, Dysport is partnering with charitable organizations, including Dress for Success and the National Coalition Against Domestic Violence, to donate money for every patient treatment registered.

Recent post-approval clinical studies have demonstrated Dysport patients experience results positively affecting their psychological well-being as well. Asked about their Dysport treatment, 92 percent of patients reported feeling confident, 90 percent of patients reported looking natural, and 92 percent of patients felt they looked attractive. Even four months post-treatment, patients reported looking at least four years younger than their actual age.