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

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

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.

Study Overview

• Status: Terminated
• Conditions: Skin Abnormalities; Skin Lesion; Sebaceous Hyperplasia
• Intervention / Treatment: Device: Nano-Pulse Stimulation (NPS)

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Clear Dermatology & Aesthetics Center / InvestigateMD
  • California
    • Sacramento, California, United States, 95816
      • Laser and Skin Surgery Center of Northern California
    • Santa Monica, California, United States, 90404
      • AVA MD
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Capital Laser & Skin Care
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • United Skin Physicians
  • 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 18 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 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:

• 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 Informed Consent.
• 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 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 target lesion.	Device: Nano-Pulse Stimulation (NPS); Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SH Lesion Clearance Rate	Clearance of SH lesions treated with NPS as rated by investigators.	60-days post-last NPS 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): December 20, 2018
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 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: Pathologic Processes; Skin Diseases; Congenital Abnormalities; Hyperplasia; Skin Abnormalities
• Other Study ID Numbers: NP-SH-009

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