Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Overview

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.

Full Title of Study: “Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 13, 2017

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Nano-Pulse Stimulation (NPS) Lesion
    • Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.
  • No Intervention: Non-Treated Lesion
    • One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pulse Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard A Nuccitelli, PhD, Study Chair, Pulse Biosciences, Inc.

Citations Reporting on Results

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.

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