Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia

• Published in: Dermatologic surgery Vol. 46; no. 6; p. 803
• Main Authors: Munavalli, Girish S, Zelickson, Brian D, Selim, Mona M, Kilmer, Suzanne L, Rohrer, Thomas E, Newman, James, Jauregui, Lauren, Knape, William A, Ebbers, Edward, Uecker, Darrin, Nuccitelli, Richard
• Format: Journal Article
• Language: English
• Published: United States 01.06.2020
• Subjects: Adult; Aged; Electric Stimulation Therapy - adverse effects; Electric Stimulation Therapy - instrumentation; Electric Stimulation Therapy - methods; Female; Follow-Up Studies; Humans; Hyperplasia - diagnosis; Hyperplasia - therapy; Male; Middle Aged; Photography; Prospective Studies; Sebaceous Glands - diagnostic imaging; Sebaceous Glands - pathology; Severity of Illness Index; Treatment Outcome
• ISSN: 1524-4725
• DOI: 10.1097/DSS.0000000000002154

Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis. Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH). This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs. At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss. Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs. ClinicalTrials.gov NCT03612570.