Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

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.

Study Overview

• Status: Completed
• Conditions: Skin Abnormalities; Skin Lesion; Sebaceous Hyperplasia
• Intervention / Treatment: Device: Nano-Pulse Stimulation Device

Detailed Description

The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Laser & Skin Surgery Medical Group, Inc.
    • San Mateo, California, United States, 94401
      • Premier Plastic Surgery
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skin Care Physicians
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialists
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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: NPS Treated SH Lesion; Nano-Pulse Stimulation Device using pre-defined energy protocol	Device: Nano-Pulse Stimulation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pulse Biosciences, Inc.
• Investigators: Study Chair: Richard Nuccitelli, PhD, Pulse Biosciences, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): September 5, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: NPS; Nano-Pulse Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Congenital Abnormalities; Hyperplasia; Skin Abnormalities
• Other Study ID Numbers: NP-SH-006

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.: Yes