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TerminatedNCT04253418Updated Oct 30, 2023

Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study

An interventional study of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia, Skin Abnormalities and Skin Lesion, sponsored by Pulse Biosciences, Inc.. Terminated at 6 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by Pulse Biosciences, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.

From the registry’s dates

  • Primary completion was May 2020, 6 years 5 months ago, and no results have been posted to the registry.
  • Registered 1 year 1 month after the study started (first participant enrolled Dec 2018, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study summary

Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.

Read the detailed description
  • Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
  • Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
  • Evaluate skin effects and adverse event rate.
02

Conditions studied

  • Sebaceous Hyperplasia
  • Skin Abnormalities
  • Skin Lesion

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03

In context

Skin Abnormalities

39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.

This study's enrollment of 125 is above the median of 39 across 26 interventional studies indexed under Skin Abnormalities.

Browse Skin Abnormalities studies →

Lead sponsor

Pulse Biosciences, Inc. is the lead sponsor of 15 studies on the registry; 5 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or Female between 18 and 75 years of age
  • Voluntary, written to participate in this clinical investigation and from whom consent has been obtained.
  • Understanding of the clinical investigation, agree to cooperate with the procedures and are willing to return for all the required follow-up visits.
  • Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit
  • Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment.
  • Clinically diagnosis of typical sebaceous hyperplasia.
  • Minimum of four SH lesions.
  • Undergo all study procedures including consent for photographs of the treated SH sites.
  • Agrees to refrain from using all other SH lesion removal products or treatments (topical medication including over-the-counter medications) during the study period.

Exclusion criteria

Exclusion Criteria:

  • Implantable electronic devices (i.e., pacemaker, implantable cardioverter defibrillator)
  • Active infection or history of infection in designated test area within 90 days prior to first treatment.
  • Not willing or able to sign the .
  • Known to be immune-compromised.
  • Known to be a keloid producer.
  • Taking blood thinning medications.
  • Insulin dependent, Type I diabetics.
  • Allergies to Lidocaine or Lidocaine-like products.
  • Employed by the sponsor, clinic site, or entity associated with the conduct of the study.
  • Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
  • Known prior inability to complete required study visits during treatment period.
  • Use of any other drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • Experimental
    Nano-Pulse Stimulation (NPS) Treated Lesion

    Nano-Pulse Stimulation of target lesion.

    Device: Nano-Pulse Stimulation (NPS)

Interventions

  • DeviceNano-Pulse Stimulation (NPS)

    Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.

06

What researchers measure

Primary outcomes

  1. SH Lesion Clearance Rate

    Clearance of SH lesions treated with NPS as rated by investigators.

    Time frame: 60-days post-last NPS treatment

07

Study locations

6 sites
  • Clear Dermatology & Aesthetics Center / InvestigateMD
    Scottsdale, Arizona 85255, United States
  • Laser and Skin Surgery Center of Northern California
    Sacramento, California 95816, United States
  • AVA MD
    Santa Monica, California 90404, United States
  • Capital Laser & Skin Care
    Chevy Chase, Maryland 20815, United States
  • United Skin Physicians
    Chestnut Hill, Massachusetts 02467, United States
  • Dermatology, Laser & Vein Specialists of the Carolinas
    Charlotte, North Carolina 28207, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04253418
Lead sponsor
Pulse Biosciences, Inc.
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Dec 20, 2018
Primary completion
May 14, 2020
Completion
Mar 26, 2021
Last update
Oct 30, 2023

Study contacts

Richard A Nuccitelli, PhD
study chair · Pulse Biosciences, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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