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TERMINATEDNA

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

NCT04249115•Pulse Biosciences, Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (7)

Clear Dermatology & Aesthetics Center / InvestigateMD

Scottsdale, Arizona, United States

Mountain Dermatology Specialists

Edwards, Colorado, United States

SKIN Associates of South Florida

Coral Gables, Florida, United States

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, United States

Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Zel Skin & Laser Specialists

Edina, Minnesota, United States

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Key Dates

Start Date

February 5, 2019

Primary Completion Date

August 13, 2020

Completion Date

April 22, 2021

Last Updated

October 30, 2023

Enrollment

175

ACTUAL participants

Conditions

Lesion SkinSeborrheic KeratosisSkin LesionBenign Skin Tumor

Interventions

Nano-Pulse Stimulation (NPS)

DEVICE

The Impact of Non-motor Symptom on the Outcome of Stroke Subjects

NCT06854497

DeliriumFatigue+5 more

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COMPLETEDNA

Optimizing the Timing for Facial Surgical Dressing Removal

NCT07441538

NevusSeborrheic Keratosis (SK)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Impact of Non-motor Symptom on the Outcome of Stroke Subjects

Optimizing the Timing for Facial Surgical Dressing Removal

Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry

The Validation of New Photographic Technology for Assessing Skin Lesions

Evaluation of the EF192B Protection Versus No Treatment

Allogeneic Platelet Rich Plasma (PRP) to Treat Diabetic Foot Ulcers