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TerminatedNCT04249115Updated Oct 30, 2023

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study

An interventional study of Nano-Pulse Stimulation (NPS) in Lesion Skin, Seborrheic Keratosis and Skin Lesion, sponsored by Pulse Biosciences, Inc.. Terminated at 7 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 Aug 2020, 6 years 1 month ago, and no results have been posted to the registry.
  • Registered 11 months after the study started (first participant enrolled Feb 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
175
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 Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.

Read the detailed description
  • Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
  • Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
  • Evaluate skin effects and adverse event rate.
02

Conditions studied

  • Lesion Skin
  • Seborrheic Keratosis
  • Skin Lesion
  • Benign Skin Tumor
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 175 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Pulse Biosciences, Inc. is the lead sponsor of 14 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

Inclusion criteria

  • Male or Female between 21 and 75 years of age
  • Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
  • Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits
  • Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
  • Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
  • Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
  • Minimum of two SK lesions
  • SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
  • Undergo all study procedures including consent for global photographs of the SK study sites
  • Agrees to refrain from using all other SK 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., automatic 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 Informed Consent
  • Known to be immune-compromised
  • Known to be 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
  • Family member of someone 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
  • Prior inability to complete required study visits during treatment period.
  • Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study
05

Study design

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

Study arms

  • Experimental
    Nano-Pulse Stimulation (NPS) Treated Lesion

    Nano-Pulse Stimulation of targeted lesion.

    Device: Nano-Pulse Stimulation (NPS)

Interventions

  • DeviceNano-Pulse Stimulation (NPS)

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

06

What researchers measure

Primary outcomes

  1. Clearance Rate of SK Lesions

    Degree of Clearance of SK lesion treated with NPS as rated by investigators.

    Time frame: 90 days post-last treatment

07

Study locations

7 sites
  • Clear Dermatology & Aesthetics Center / InvestigateMD
    Scottsdale, Arizona 85255, United States
  • Mountain Dermatology Specialists
    Edwards, Colorado 81632, United States
  • SKIN Associates of South Florida
    Coral Gables, Florida 33146, United States
  • Chicago Cosmetic Surgery and Dermatology
    Chicago, Illinois 60654, United States
  • Skin Care Physicians
    Chestnut Hill, Massachusetts 02467, United States
  • Zel Skin & Laser Specialists
    Edina, Minnesota 55424, 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
NCT04249115
Lead sponsor
Pulse Biosciences, Inc.
Responsible party
Sponsor
First posted
Jan 30, 2020
Start date
Feb 5, 2019
Primary completion
Aug 13, 2020
Completion
Apr 22, 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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