Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis

The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Seborrheic Keratosis; Lesion Skin
• Intervention / Treatment: Device: Nano-Pulse Stimulation (NPS)

Detailed Description

Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

The specific objectives of this study are to:

• Document the non-treated appearance of off-face SKs.
• Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion.
• Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • 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
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Laser & Dermatologic Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Willing to sign the informed consent
• Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
• Medically determined candidate for at least 4 off-face SK lesions
• Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
• Willing to have three of the designated SK lesions treated in a single treatment session
• Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
• Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
• No subject identity will be possible via the "lesion-only" photograph
• No evidence of active infection in the designated tissue prior to treatment
• Is not allergic to Lidocaine or Lidocaine-like products
• Not pregnant or lactating

Exclusion Criteria:

• Has an implantable electronic device (e.g., automatic defibrillator)
• Active infection or history of infection within 90 previous days in designated test area
• Not willing or able to sign the Informed Consent
• Non-English speaking or reading
• Is known to be immune-compromised
• Known to be a keloid producer
• On blood thinning medications
• Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nano-Pulse Stimulation (NPS) Lesion; Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.	Device: Nano-Pulse Stimulation (NPS); The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.
No Intervention: Non-Treated Lesion; One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance of SK Lesions	Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.	106-day post-treatment

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Hruza GJ, Zelickson BD, Selim MM, Rohrer TE, Newman J, Park H, Jauregui L, Nuccitelli R, Knape WA, Ebbers E, Uecker D. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses. Dermatol Surg. 2020 Sep;46(9):1183-1189. doi: 10.1097/DSS.0000000000002278.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): May 22, 2018

Study Registration Dates

• First Submitted: February 17, 2019
• First Submitted That Met QC Criteria: February 17, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Seborrheic Keratosis; Nano-Pulse Stimulation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
• Other Study ID Numbers: NP-SK-002

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