NCT04249115

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

January 27, 2020

Last Update Submit

October 26, 2023

Conditions

Lesion SkinSeborrheic KeratosisSkin LesionBenign Skin Tumor

Outcome Measures

Primary Outcomes (1)

  • Clearance Rate of SK Lesions

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

    90 days post-last treatment

Study Arms (1)

Nano-Pulse Stimulation (NPS) Treated Lesion

EXPERIMENTAL

Nano-Pulse Stimulation of targeted lesion.

Device: Nano-Pulse Stimulation (NPS)

Interventions

Nano-Pulse Stimulation (NPS)DEVICE

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

Nano-Pulse Stimulation (NPS) Treated Lesion

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clear Dermatology & Aesthetics Center / InvestigateMD

Scottsdale, Arizona, 85255, United States

Location

Mountain Dermatology Specialists

Edwards, Colorado, 81632, United States

Location

SKIN Associates of South Florida

Coral Gables, Florida, 33146, United States

Location

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Zel Skin & Laser Specialists

Edina, Minnesota, 55424, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Richard A Nuccitelli, PhD

    Pulse Biosciences, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 30, 2020

Study Start

February 5, 2019

Primary Completion

August 13, 2020

Study Completion

April 22, 2021

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(7)