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

Dermatol Surg. 2020 Jun;46(6):803-809. doi: 10.1097/DSS.0000000000002154.

Abstract

Background: 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.

Objective: Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH).

Methods: 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.

Results: 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.

Conclusion: Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs.

Trial registration: ClinicalTrials.gov NCT03612570.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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

Associated data

  • ClinicalTrials.gov/NCT03612570