NCT03612570

Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Completed NA Results posted Last updated 12 April 2024

What this trial tests

NA trial testing Nano-Pulse Stimulation Device in Skin Lesion in 72 participants. Completed in 28 November 2018.

Timeline

28 June 2018

Primary endpoint
5 September 2018

28 November 2018

Quick facts

Lead sponsor	Pulse Biosciences, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	28 June 2018
Primary completion	5 September 2018
Estimated completion	28 November 2018
Sites	5 locations across United States

Drugs / interventions tested

• Nano-Pulse Stimulation Device

Conditions studied

• Skin Lesion — all drugs for Skin Lesion →
• Skin Abnormalities — all drugs for Skin Abnormalities →
• Sebaceous Hyperplasia — all drugs for Sebaceous Hyperplasia →

Sponsor

Pulse Biosciences, Inc.

Who can join

Adults 18 to 70, any sex, with Skin Lesion or Skin Abnormalities. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Cleared SH Lesions Primary · 60-days follow-up post-last treatment

SH lesion clearance was assessed live by investigators for each treated SH lesion (n=222) at 60-days post-last treatment using a 4-point scale (i.e., 0, 1, 2, 3) where each number corresponded to Clear, Mostly Clear, Partially Clear, or Not Clear, respectively. Lower scores mean better outcome, i.e., 0=Clear while a 3=Not Clear.

Group	Value	95% CI
Total Number of Cleared Lesions With Sebaceous Hyperplasia (SH)	99.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Skin effects (hyperpigmentation) were observed per SH lesion at the 5-day, 30-day, 60-day and if applicable 90-day follow-up periods.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NPS Treated Sebaceous Hyperplasia (SH) Lesion

Serious: 0/71 (0%)

Deaths: 0/71

Other adverse events (1 terms — click to expand)

Reaction	System	NPS Treated Sebaceous Hype…
Post-Inflammatory Hyperpigmentation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03612570 adverse events section.

Sponsor's own description

This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.
   Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, et al · · 2020 · cited 26× · PMID 31592824 · DOI 10.1097/dss.0000000000002154
2. Microneedles as a Promising Technology for Disease Monitoring and Drug Delivery: A Review.
   Hulimane Shivaswamy R, Binulal P, Benoy A, Lakshmiramanan K, et al · · 2025 · cited 15× · PMID 39802146 · DOI 10.1021/acsmaterialsau.4c00125