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

Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis

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.

Study Overview

• Status: Terminated
• Conditions: Skin Lesion; Seborrheic Keratosis; Lesion Skin; Benign Skin Tumor
• Intervention / Treatment: Device: Nano-Pulse Stimulation (NPS)

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.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Clear Dermatology & Aesthetics Center / InvestigateMD
  • Colorado
    • Edwards, Colorado, United States, 81632
      • Mountain Dermatology Specialists
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Associates of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic Surgery and Dermatology
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skin Care Physicians
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialists
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano-Pulse Stimulation (NPS) Treated Lesion; Nano-Pulse Stimulation of targeted lesion.	Device: Nano-Pulse Stimulation (NPS); Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance Rate of SK Lesions	Degree of Clearance of SK lesion treated with NPS as rated by investigators.	90 days post-last treatment

Collaborators and Investigators

• Sponsor: Pulse Biosciences, Inc.
• Investigators: Study Chair: Richard A Nuccitelli, PhD, Pulse Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): August 13, 2020
• Study Completion (Actual): April 22, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
• Other Study ID Numbers: NP-SK-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No