Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses.

ABSTRACT

BACKGROUND: Nanosecond pulsed electric field technology (also known as Nano-Pulse Stimulation or NPS) is a nonthermal, drug-free, energy-based technology that has demonstrated effects on cellular structures of the dermis and epidermis in previous clinical studies. OBJECTIVE: To evaluate the safety and efficacy of a single NPS treatment for clearing seborrheic keratoses (SKs). MATERIALS AND METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. Fifty-eight subjects had 3 of 4 confirmed SK lesions treated, resulting in 174 total treated lesions. Subjects returned for 5 to 6 follow-up evaluations and photographs. RESULTS: At 106 days after NPS treatment, 82% of treated seborrheic keratoses were rated clear or mostly clear by the assessing physician. Seventy-one percent of lesions were rated clear or mostly clear by the 3 independent reviewers based on the 106-day photographs. All treated subjects returned for all study visits, and 78% of the subjects were satisfied or mostly satisfied with the outcome of the treatment. No adverse events were reported. CONCLUSION: The NPS procedure was well tolerated and effective in the removal of SKs.