Medesthetics

APR 2019

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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56 APRIL 2019 | Med Esthetics NEWSMAKERS | By Inga Hansen Two new products—Sebacia Microparticles and Sienna Bio- pharmaceuticals Photoparticle Therapy—may provide an effective treatment option for patients with light hair seeking permanent laser hair reduction. Sebacia's gold microparti- cles received FDA approval in Fall 2018 for the treatment of acne, and the company is now launching trials for use of the product for the permanent reduction of light hair. Sienna Biopharmaceuticals recently completed three clinical studies of its silver photoparticles for light hair removal. "We designed three different particles to work with the three most common lasers in clinics today—the 810nm diode laser, 755nm alexandrite and 1,064nm Nd:YAG. Each of these particles is tuned to the wavelength of that laser," says Frederick Beddingfi eld, MD, PhD, president and CEO of Sienna Biopharmaceuticals. Clinical investigators Mitchel Goldman, MD, Brian Zelickson, MD, Jeffrey Dover, MD, Roy Geronemus, MD, Suzanne Kilmer, MD, and Mathew Avram, MD—who is a member of the company's corporate advisory board— conducted the three studies, which included roughly 60 patients each and examined use of the photoparticles with each of the three laser wavelengths. Patients were followed for 30 days following six sessions using one laser pass, and the company will continue to track outcomes for 60 days, 90 days and one year. "These were identical studies comparing our Photopar- ticle Therapy to the use of laser alone," says Dr. Bedding- fi eld. "Hair removal from baseline was statistically signifi cant in all three with an average reduction of about 30 percent. The differentiation from the laser alone to procedure was greatest with the 810nm laser." The silver particles are applied topically in a suspension and then massaged into the hair follicles where they are ac- tivated by the laser to destroy the follicles. One of the chal- lenges for both the gold and silver particles has been getting them into the follicles. The studies' methods included fi rst epilating the hair in the treatment area and then using a massager for two minutes to help drive the particles into the follicles. "We want to fi ll that hair follicle shaft with the silver photoparticles. In a normal setting the bulk of that opening is taken up by the hair shaft. Removing the hair allows more of the silver to get down there," says Dr. Beddingfi eld. "The reason we didn't use wax is that there was some concern the wax could plug up those pores, but with sugaring, you can easily wash it off with a baby wipe after you've epilated the hair." The company will submit data from the three trials to the FDA within the next few months in hopes of gaining approval for all three photoparticles and wavelengths by late Q3 or early Q4. "In parallel, we are working on commercial supply so that upon approval and clearance, we will have product ready to go," says Dr. Beddingfi eld. "Laser hair removal is one of the top aesthetic procedures globally, but for a number of patients with light hair, it is not currently an option. We've heard from a lot of people that they are excited about this treatment, so we're focused on the best way to get approval and the best way to get this into the hands of the physician." Inga Hansen is the executive editor of MedEsthetics. "Laser hair removal is one of the top aesthetic procedures globally, but for a number of patients with light hair, it is not currently an option." Metal particles that allow for laser reduction of light hair may be coming to offi ces this year. HOPE FOR LIGHT HAIR Frederick Beddingfi eld, MD, PhD

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