During a virtual course on laser and aesthetic skin therapy, Yakir Levin, MD, PhD, likened nano-pulse stimulation to microneedling or radiofrequency microneedling “in that you have an array of microneedles that go into the skin,” he said. “However, it is actually completely different.”
The CellFX System uses nano-pulse stimulation to deliver ultrashort electrical energy pulses into the skin of target lesions via a console-based handheld applicator. In September 2022, the Food and Drug Administration cleared the CellFX system for treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-II. This followed a general clearance of the device in 2021 for dermatologic procedures requiring ablation and resurfacing of the skin.
Dr. Yakir Levin
Pulses from the device deliver a “constant electrical potential gradient across cell membranes and organelle membranes, causing them to break down,” explained Dr. Levin, a dermatologist and physician scientist at Massachusetts General Hospital, Boston, where he practices cosmetic dermatology and conducts research on birthmarks in children. This creates pores in those membranes “and leads to a controlled form of cell death,” he said. “As a result, this treatment is limited to cells, so you can do it in the dermis without damaging the collagen network. It spares tissue that’s outside of the field, and it’s nonthermal.”
Images from electron microscopy have demonstrated swelling of the mitochondria and breakdown of nuclei within 2 hours of treatment in a rat study. “Within 1 day of treatment you have death of the cells and the beginning of involution of the lesion,” he said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “This presents us with the opportunity to treat dermal lesions without causing damage to the epidermis or to the acellular portion of the dermis.”
In published studies, nano-pulse stimulation has been shown to be effective for treating sebaceous hyperplasia and warts. According to Dr. Levin, clinicians typically treat sebaceous hyperplasia with an radiofrequency microneedle or electrodesiccation, “where we shave off the top but do not try to hit the bottom because we don’t want to cause scarring of the dermis,” he said. “Using the nano-pulse stimulation technology, however, you end up with involution of the sebaceous lesion without damaging the surrounding dermis.”
In a prospective, randomized study, 72 individuals with sebaceous gland hyperplasia received nano-pulse stimulation to 222 lesions and they returned for three to four follow-up evaluations with photographs. At the final study visit, investigators rated 99.6% of the sebaceous gland lesions as clear or mostly clear, while 79% of the study participants said they were “satisfied” or “mostly satisfied” with the outcome.
At posttreatment day 60, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild posttreatment hyperpigmentation.
In a more recent study, researchers used the CellFX System to treat 195 cutaneous warts up to 10 mm wide in 62 individuals enrolled at one of five sites. They found that 75% of common warts, 73% of flat warts, and 44% of plantar warts were completely clear 60 days following the last nano-pulse stimulation treatment and did not recur within the 120-day observation period.
The most common reactions at the treatment sites were erythema (51%) and eschar formation (23%) on day 30.
According to Dr. Levin, promising future applications of nano-pulse stimulation include treatment of syringomas, dermatofibromas, and basal cell carcinomas.
Dr. Levin reported financial interest in Accure Acne, Avava Medical, and Soltego. The CellFX system was developed and is marketed by Pulse Biosciences.