Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

NCT03612570 | Completed Results FDA Device

• 1 other identifier: NP-SH-006
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

Brief Summary

This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

Conditions

Skin Lesion; Skin Abnormalities; Sebaceous Hyperplasia

Keywords

Nano-Pulse Stimulation; NPS

Outcome Measures

Primary Outcomes (1)

• Total Number of Cleared SH Lesions

  SH lesion clearance was assessed live by investigators for each treated SH lesion (n=222) at 60-days post-last treatment using a 4-point scale (i.e., 0, 1, 2, 3) where each number corresponded to Clear, Mostly Clear, Partially Clear, or Not Clear, respectively. Lower scores mean better outcome, i.e., 0=Clear while a 3=Not Clear.

  60-days follow-up post-last treatment

Study Arms (1)

NPS Treated SH Lesion

EXPERIMENTAL

Nano-Pulse Stimulation Device using pre-defined energy protocol

Device: Nano-Pulse Stimulation Device

Interventions

Nano-Pulse Stimulation Device DEVICE

NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.

NPS Treated SH Lesion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females
• Presents with at least 2 and up to 5 clinically visible SH lesions
• Understands that 1 lesion will remain untreated to act as a reference
• Lesions must measure no greater than 2.5 x 2.5 at the outside margin
• Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion
• Selection of the non-treated reference lesion will be randomly identified
• Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days
• Agrees to photographic or other image capture methods of both the treated and untreated lesions.
• Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study
• Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days
• Is not allergic to Lidocaine or Lidocaine-like products

You may not qualify if:

• Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator
• Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device
• SH lesions are located within the eye orbit or on the nose
• Active infection or history of infection in designated test area within 90 days prior to study initiation
• Use of oral steroid and/or retinoid use within the last 12 months
• Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start
• Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start
• Taking blood thinning medications
• Has Insulin dependent diabetes
• Is known to be pregnant or lactating female

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (5)

Laser & Skin Surgery Medical Group, Inc.

Sacramento, California, 95816, United States

Location

Premier Plastic Surgery

San Mateo, California, 94401, 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, PLLC

Charlotte, North Carolina, 28207, United States

Location

Related Publications (1)

• Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, Rohrer TE, Newman J, Jauregui L, Knape WA, Ebbers E, Uecker D, Nuccitelli R. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia. Dermatol Surg. 2020 Jun;46(6):803-809. doi: 10.1097/DSS.0000000000002154.

  PMID: 31592824 RESULT

MeSH Terms

Conditions

Skin Abnormalities

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: William A. Knape
• Organization: Pulse Biosciences, Inc.

bill.knape@pulsebiosciences.com

(510) 906-4649

Study Officials

• Richard Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: July 27, 2018
• First Posted: August 2, 2018
• Study Start: June 28, 2018
• Primary Completion: September 5, 2018
• Study Completion: November 28, 2018
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)