NOV-DEC 2018

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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BEST PR ACTICES 14 NOVEMBER/DECEMBER 2018 | MedEsthetics © GETTY IMAGES Higher doses of Botox Cosmetic are well tolerated and offer better longevity than the traditional 20-unit dose, according the results of a new clinical study conducted by Allergan. The trial was designed to evaluate the duration of effect and safety of Botox Cosmetic at 40, 60 and 80 unit doses versus the 20-unit dose in patients with moderate-to-severe glabellar lines. Of the 233 subjects who completed the study, 32 percent in the 40- unit group, 30.6 percent in the 60-unit group and 38.5 percent in the 80-unit group were responders at week 24 as compared to 16 percent in the 20-unit group. For responders with a >1 point improvement, the time to return to baseline also dem- onstrated 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. Across all studied doses there was one case of eyelid ptosis at 80 units and one case of eyebrow ptosis at 20 units. A new treatment for moderate-to-severe infl ammatory acne is coming to market: gold microparticles. Sebacia Microparticles have been cleared for sale by the U.S. Food and Drug Administration (FDA) based on results of a U.S. pivotal, randomized, controlled, blinded trial evaluating 168 patients with mild-to-moderate acne using either Sebacia Microparticles with laser or laser alone. The treatment arm demonstrated a 53 percent median reduction in infl ammatory lesion count compared to 45 percent with laser alone. The study met its primary endpoint of demonstrating noninferiority 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). All reported adverse events were of mild-to-moderate intensity. The company anticipates that the microparticles will be commercially available in the U.S. in mid-2019. For more information, visit HIGHER-DOSE BOTOX FOR LONGEVITY MICRONEEDLING REDUCES THE SIGNS OF FACIAL AGING Four sessions with an automated micro- needling device signifi cantly improves skin laxity, skin texture and wrinkles with maxi- mum effect seen 150 days following treat- ment, according to the results of a recent study published in the Journal of Clinical and Aesthetic Dermatology (August 2018). Au- thor Glynis Ablon, MD, FA AD, treated 48 subjects (39-67 years old) with the Exceed automated microneedling device (Amiea Med). The clinical endpoint was pinpoint bleeding. Skin texture, skin laxity, wrinkle depth and wrinkle severity were assessed at baseline, before subsequent microneedling sessions (at 30, 60 and 90 days) and 150 days after the fi rst treatment. Wrinkles were assessed using the Lem- perle grading scale. Skin laxity and texture were assessed using a modifi ed Alexiades- Armenakas grading scale, and skin topogra- phy in the periorbital and mesolabial areas was assessed using PRIMOS digital fringe projection and VISIA photography. At Day 90, glabella frown lines, periorbital lines, cheek folds and upper lip lines had improved by at least one grade. At Day 150, horizontal forehead lines, glabella frown lines, periorbital lines, cheek folds, upper lip lines and labiomental crease had improved by at least one grade, and mean improvements were observed for all rough- ness parameters in both the periorbital and mesolabial regions. Of the nine adverse events, eight were herpes simplex labialis outbreaks and one subject complained of excessively dry skin following treatment. FDA CLEARS SEBACIA MICROPARTICLES FOR ACNE

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