ASLMS / ASDSA / FDA Session Summary
July 18, 2018
Dr. Kachiu C. Lee,
Director of Government
Communication and Education
ASLMS has been collaborating with the FDA for years to provide educational meetings at the FDA. The goal of the meetings is to provide an unbiased educational forum and two-way exchange of information about lasers and related technology and the challenges of bringing technology forward.
On July 18, 2018 Tina Alster, MD, Heidi Prather, MD, FAAD and Dieter Manstein, MD, PHD met with the FDA and members of the ASDSA to discuss radiofrequency and microneedling.
Dr. Heidi Prather started the FDA session by discussing radiofrequency, going over the underlying mechanism of action and physics of how each device worked. Specifically, she discussed the differences between capacitive heating vs inductive heating, and monopolar vs bipolar devices. Because radiofrequency devices often combine microneedling and energy, Dr. Prather pointed out both the non-thermal and thermal benefits of these types of devices. Non-thermal benefits included inducing enzyme activity, mRNA, and heat shock genes while thermal benefits included neocollagenesis and tissue tightening. Dr. Prather also discussed the array of at-home devices available over the counter, comparing these to in-office devices. The in-office devices offered options of using uninsulated needles, insulated needles (for enhanced epidermal penetration), and variable needle lengths allowing for different depth of penetrations. Potential treatment indications included transdermal drug delivery, scars, active acne, skin laxity, axillary hyperhidrosis, and androgenic alopecia.
Dr. Tina Alster provided a general overview of microneedling, discussing the mechanism of action, depth of penetration, treatment indications, and results of treatment. Different microneedling device options were reviewed, including the microneedling roller compared to the pen device. In the Q&A session, she pointed out that the microneedling roller can be very difficult to clean out, which makes it difficult to adopt into everyday clinical practice. Fixed-needle rollers are typically marketed for at-home use. Comparatively, the electric-powered microneedling pen devices offer individual disposable tips with an array of 12 to 36 needles, and adjustable speeds, allowing for versatility in dermal penetration during treatments. Dr. Alster also reviewed treatment indications, such as rhytides, scars, enlarged pores, striae distensae, and transverse neck rhytides. Typical post treatment considerations such as applying pressure and ice for hemostasis, use of hydrocortisone or other soothing balm 2-4x/day, and re-treatment time intervals were also discussed.
Dr. Dieter Manstein was also present as a guest during this session and provided insight during the Q&A session on the risks/benefits of microneedling vs heat-induced fractionated injury.