News + Trends

ASDS 2018 Survey: Close to 70 percent of Consumers Thinking About Cosmetic Treatments

Almost 70 percent of consumers are considering a cosmetic treatment, and more than half would prefer to pay more up front to lower their annual skincare costs, according to the 2018 American Society for Dermatologic Surgery (ASDS) Consumer Survey on Cosmetic Dermatologic Procedures.

Excess fat—on any part of the body—remained the top concern for consumers for the sixth year in a row at 86 percent. Skin discoloration is an increasing concern and tied for the second spot this year, reinforcing the need for ongoing sun protection education. In addition, more than 70 percent of consumers are bothered by excess fat under the chin/neck and skin, lines and wrinkles around the eyes, and skin texture and/or discoloration. Other areas of concern receiving more than 60 percent of consumers' votes are wrinkles in the mid-face, in the forehead area, between the eyebrows, neck, and check, and overall sagging facial skin.

The survey also uncovered the reasons why people are turning to cosmetic procedures. Holding the top three spots for six consecutive years are the desires to:

1. “Feel more confident.”
2. “Feel more attractive.”
3. “Look as young as I feel or better for my age.”

New to the survey this year were questions regarding consumers' skin care product choices. The majority of consumers are spending up to $100 per month on skin care products including cleansers, serums, masks, sunscreens and creams. More than half of consumers would prefer to pay more up front to lower their skin care costs annually.

Of the 11 factors influencing the selection of a practitioner, choices aligning to physician expertise continue to receive top ratings. The specialty in which the physician is board-certified, referral from a physician, and the level of the physician's licensure ranked as leading influencing factors.

Allergan Shares Results of Higher Dose Botox Cosmetic for the Treatment Glabellar Lines

Allergan plc shared clinical study results of higher doses of Botox Cosmetic compared to Botox Cosmetic 20 unit dose at week 24 in patients with moderate to severe glabellar lines.

Allergan conducted this trial to evaluate the duration of effect and safety of Botox Cosmetic 40, 60, and 80 unit doses in patients with moderate to severe glabellar lines. The primary efficacy endpoint was met and was statistically significant for Botox Cosmetic 40 and 80 units versus 20 unit in 226 subjects at 24 weeks (analysis, ≥1 point improvement in Facial Wrinkle Scale (FWS) from baseline assessed by Investigator at Maximum Frown).

In this trial, 32 percent of patients were responders at week 24 in the Botox Cosmetic 40 unit group, 30.6 percent in the Botox Cosmetic 60 unit group, and 38.5 percent in the Botox Cosmetic 80 unit group as compared to 16 percent in the 20 unit group. The dose effect was observed across additional outcome variables.

For responders with a >1 point improvement, the time to return to baseline also demonstrated a dose-effect. The median time on the Kaplan-Meier curve was 19.7 weeks for 20 Units and 24.0 weeks for 40 Units, suggesting the median benefit of 40 units is between 20 and 24 weeks.

The higher doses of Botox Cosmetic were safe and well tolerated. In a total 233 patients evaluable for safety, there was one serious adverse event (SAE) unrelated to treatment. Overall treatment related adverse events (AEs) compare favorably with USPI labeled AEs and no new safety signals were identified. Across all studied doses there was 1 case (0.4 percent) eyelid ptosis at 80 unit and 1 case (0.4 percent) eyebrow ptosis at 20 unit.

New Laser Handpiece Clears Green, Blue, and Purple Tattoos in Fewer Treatments

A new titanium sapphire laser handpiece can clear green, blue, and purple tattoo pigments in fewer treatments, according to a new study in Lasers in Surgery and Medicine (LSM).

Researchers led by American Society for Laser Medicine and Surgery President Eric F. Bernstein, MD, MSE, Director of the Main Line Center for Laser Surgery, in Ardmore, PA, investigated the safety and efficacy of the new 785nm Ti-Sapphire laser for treating blue, green, and purple tattoo inks as an addition to a picosecond-domain 1,064nm and 532nm laser platform.

This 785nm, picosecond-domain, laser-pumped-laser demonstrates safe and effective removal of multicolor tattoos. Although clearance was shown for a multitude of colors including black, the 785nm laser wavelength has special affinity to purple, blue and green tattoo pigments.

“The laser-pumped-laser concept enables delivery of multiple discrete wavelengths from a single laser platform. A commercial 785nm Ti-Sapphire laser has been a long time coming,” says Dr. Bernstein in a news release. “Having a picosecond-domain version for treating blue, green and purple tattoos is a big advantage.”

Galderma Launches “Face Your Hands” Campaign with Celebrity Manicurist

Galderma Laboratories' Restylane Lyft is partnering with celebrity manicurist Deborah Lippmann for the “Face Your Hands” campaign, which aims to educate women on the steps they can take to achieve more youthful hands.

According to a recent survey conducted by Galderma, nearly two in three women (65 percent) age 40 and over think their hands make them look older than their age. Restylane Lyft is the only hyaluronic acid (HA) dermal filler FDA-approved to help reverse the signs of volume loss in aging hands. Radiesse (Calcium Hydroxylapatite) is also approved for the correction of lost volume in hands.

As part of the initiative, Ms. Lippmann will connect with women across the country and share her nail care and manicure tips along with her personal experience with Restylane Lyft for hands.

“Like Deborah Lippmann, many of my patients notice that their hands do not look as youthful as their faces, but they can't pinpoint the reason. As you get older, the natural fat in the hands begins to deteriorate, and the underlying tendons and veins become more pronounced,” says New York City dermatologist Doris Day, MD. “These are signs of volume loss which requires more than topical creams or lasers to treat. The ideal option is an injectable dermal filler like Restylane Lyft, the first and only HA filler for the hands.”

The Restylane Survey was conducted among 1,000 nationally representative US women, ages 35+, between February 26 and March 5, 2018, using an email invitation and an online survey.

Nestlé to Explore Strategic Options for Nestlé Skin Health

As part of its regular strategy review earlier this year, Nestlé's Board of Directors assessed Nestlé's Nutrition, Health and Wellness strategy. The Board fully confirmed the company's strategic direction and resolved to sharpen its focus on food, beverage, and nutritional health products.

After further analysis and consideration, the Board reported that it has come to the conclusion that the future growth opportunities of Nestlé Skin Health lie increasingly outside the group's strategic scope and has therefore decided to explore strategic options for Nestlé Skin Health. This review is expected to be completed by mid-2019.

Nestlé Skin Health provides science-based solutions to meet the specific skin health needs of healthcare professionals, patients, and consumers. It offers a range of medical and consumer brands through three complementary business units, including Epiduo and Soolantra in prescription, Restylane and Azzalure in aesthetics, and Cetaphil and Proactiv in consumer care.

New for EBD-Based Acne Care: Sebacia Microparticles Cleared

Sebacia Microparticles are now FDA-cleared for use in the treatment of acne. The clearance comes on the heels of a pivotal study demonstrating the clinical safety and efficacy of the micoparticles.

Sebacia Microparticles selectively target the sebaceous glands and are indicated for use as an accessory to 1064nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris. In the EU, Sebacia Microparticles is CE marked.

Results from a US pivotal, randomized, controlled, blinded trial evaluating 168 patients with mild to moderate acne using either Sebacia Microparticles with laser or laser alone show that Sebacia Microparticles treatment demonstrated a 53 percent median reduction in inflammatory lesion count (ILC), compared to 45 percent median reduction achieved by the laser treatment alone. The study achieved its primary endpoint of demonstrating non-inferiority at 12 weeks. It also achieved several secondary endpoints including 30.1 percent of patients treated with Sebacia Microparticles achieving a clear or almost clear IGA score (Investigator's Global Assessment of acne severity)—a significant accomplishment for an FDA-cleared acne product, the company says. All reported adverse events, regardless of study treatment, were of mild to moderate intensity.

Candela Partners with Vascular Birthmarks Foundation To Provide Pro-Bono Laser Treatments

More than 30 pre-qualified patients received treatment with the Vbeam Pulsed Dye Laser to commence the Vascular Birthmarks Foundation's 18th Annual Conference.

Candela Corporation partnered with the Vascular Birthmarks Foundation (VBF) to provide pro-bono Vbeam laser treatments to children and adults with birthmarks, port wine stains, and other vascular related skin conditions as a kickoff to the VBF 18th Annual Conference. Treatments were performed at the Laser & Skin Surgery Center of New York in Manhattan on Friday, October 5 by the center's director, Dr. Roy Geronemus.

One in ten children are born with a vascular birthmark. “Vascular lesions, especially those on the face, have serious physical and psychological effects on patients,” says Dr. Geronemus. “I am honored to be a part of the effort to provide patients with this life changing treatment. The Vbeam is without a doubt an incredibly safe and effective treatment for these conditions.”

Thermi Debuts Arvati Platform

Thermi, an Almirall company, is launching Arvati, a next-generation 510k FDA-cleared, true temperature-controlled radiofrequency platform that powers a range of Thermi procedures including ThermiTight, ThermiRase, ThermiSmooth Face, and ThermiVa.

Arvati delivers rapid, precise, and consistently controlled output of radiofrequency to tissue to induce positive tissue change by stimulating collagen production to enhance various skin areas. The platform is built upon increased power as well as optimized two-way real time temperature-controlled algorithms.

Arvati amplifies the science of heat with Epic Technology. With optimized radiofrequency delivery, Arvati provides consistent dosage of heat while keeping clinicians in complete control throughout the treatment. The technology also features an enhanced 50-watt capacity generator, which maximizes the power to efficiently treat all body areas while helping clinicians reach desired set temperatures 63 percent faster, thereby significantly reducing total treatment times. Initial experience shows temperature stays within 1 degree of the set temperature 99.7 percent of the treatment time.

WHAT WE KNOW ABOUT BIA-ALCL

To get a better handle on what we know—and don't know—about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Modern Aesthetics® had a candid conversation with William P. Adams, Jr., MD, a plastic surgeon in Dallas and an Associate Clinical Professor of Plastic Surgery at UT Southwestern Medical Center. Dr. Adams also serves as Treasurer of the American Society for Aesthetic Plastic Surgery's Board of Directors. He urged prudence and proactivity, not paranoia when it comes to addressing BIA-ALCL risk.

MA: What is BIA-ALCL?

William P. Adams, Jr., MD: BIA-ALCL is a rare and treatable type of T-cell lymphoma that can develop around breast implants. It is not a breast cancer. Clinically the disease is typically very indolent and ongoing research is being done to determine if it is better classified as a lymphoproliferative disorder, a spectrum of disease from indolent/non-malignant to full-blown advanced lymphoma.

The FDA estimates that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from one in 3,817 to one in 30,000.

MA: Are there any common denominators?

Dr. Adams: The condition has only been seen in textured implants thus far. There have been no confirmed smooth surface-only cases of BIA-ALCL reported. The condition has been diagnosed with both silicone gel- and saline-filled implants.

MA: Is there a differential risk when it comes to degrees of texture in breast implants?

Dr. Adams: Yes, there appears to be a differential risk based on the grade of texture. The more heavily textured the implant, the greater the ALCL risk. It is about one in 3,000 for Grade 3/macro-textured implants and one in 82,000 for Grade 2/micro-textured implants. This is largely due to the surface area on the devices.

In the US, we mainly use smooth breast implants (>90 percent). In other countries, textured implants are the norm.

MA: Do we know what causes BIA-ALCL?

Dr. Adams: Exactly what causes BIA-ALCL is not fully understood yet, but the best science points to a combination of four requirements: 1. Chronic bacterial inflammation with a gram-negative microbiome, 2. Textured implant, 3. Genetic predisposition, 4. Time (mean 8.5 years).

MA: What are the symptoms of BIA-ALCL? Is it Treatable?

Dr. Adams: Symptoms may include breast enlargement and/or serum around the implant. It is an indolent disease in most cases , and all of those individuals who have been diagnosed early and treated appropriately have been cured. We take out the capsule and the implant (the same treatment as for capsular contracture). Early diagnosis equals a great prognosis and a 100 percent cure rate.

MA: What are obstacles to early diagnoses?

Dr. Adams: This is such a rare problem. Awareness is key for both physicians and surgeons. Any breast implant patient that notices any abnormality, especially enlargement, firmness, shape changes should go be evaluated by their plastic surgeon. Some of these patients end up seeing their internists or emergency care centers where they are not aware of BIA-ALCL. The most common presentation is a seroma around the implant. Any patient with an enlarged breast should have ultrasound performed and fluid sent for analysis. We collect fresh seroma fluid and part of the capsule and send for cytology and to test for CD30. CD30 is not diagnostic for BIA-ALCL; it is a marker of T-cell activation.

MA: What type of follow-up is recommended for breast implant patients?

Dr. Adams: All breast implant patients should have long-term follow-up with their surgeons. If a patient who has textured implants is doing fine, they don't need any treatment. That said, some people will decide textured breast implants should be removed. All patients should connect with their plastic surgeon and get personal recommendations.

Some proactive plastic surgeons have elected to reach out to their breast implant patients and let them know about BIA-ALCL and its signs and symptoms as well as stress that any patient with concerns come in for a full evaluation. Some surgeons have gotten in front of the news and urged patients with textured implants to seek explantation. This is not supported by the data. It is important to remember that the vast majority of our patients will not have a problem, and that BIA-ALCL is easily treated and cured when diagnosed early.

All cases should be reported to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE) Registry.