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

NCT04253418 | Terminated FDA Device

• 1 other identifier: NP-SH-009
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Sebaceous Hyperplasia; Skin Abnormalities; Skin Lesion

Outcome Measures

Primary Outcomes (1)

• SH Lesion Clearance Rate

  Clearance of SH lesions treated with NPS as rated by investigators.

  60-days post-last NPS treatment

Study Arms (1)

Nano-Pulse Stimulation (NPS) Treated Lesion

EXPERIMENTAL

Nano-Pulse Stimulation of target lesion.

Device: Nano-Pulse Stimulation (NPS)

Interventions

Nano-Pulse Stimulation (NPS) DEVICE

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

Nano-Pulse Stimulation (NPS) Treated Lesion

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (6)

Clear Dermatology & Aesthetics Center / InvestigateMD

Scottsdale, Arizona, 85255, United States

Location

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

AVA MD

Santa Monica, California, 90404, United States

Location

Capital Laser & Skin Care

Chevy Chase, Maryland, 20815, United States

Location

United Skin Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Skin Abnormalities

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin 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 28, 2020
• First Posted: February 5, 2020
• Study Start: December 20, 2018
• Primary Completion: May 14, 2020
• Study Completion: March 26, 2021
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)