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Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Primary Purpose

Lesion Skin, Seborrheic Keratosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nano-Pulse Stimulation (NPS)
Sponsored by
Pulse Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lesion Skin focused on measuring Nano-Pulse Stimulation, Seborrheic Keratosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Premier Plastic Surgery
  • Skin Care Physicians
  • Zel Skin & Laser Specialists
  • Laser & Dermatologic Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Nano-Pulse Stimulation (NPS) Lesion

Non-Treated Lesion

Arm Description

Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.

One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2019
Last Updated
July 31, 2023
Sponsor
Pulse Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03846531
Brief Title
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
Official Title
Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
May 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulse Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lesion Skin, Seborrheic Keratosis
Keywords
Nano-Pulse Stimulation, Seborrheic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
Masking
Outcomes Assessor
Masking Description
A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nano-Pulse Stimulation (NPS) Lesion
Arm Type
Active Comparator
Arm Description
Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.
Arm Title
Non-Treated Lesion
Arm Type
No Intervention
Arm Description
One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.
Intervention Type
Device
Intervention Name(s)
Nano-Pulse Stimulation (NPS)
Intervention Description
The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.
Primary Outcome Measure Information:
Title
Clearance of SK Lesions
Description
Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.
Time Frame
106-day post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Nuccitelli, PhD
Organizational Affiliation
Pulse Biosciences, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Premier Plastic Surgery
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Skin Care Physicians
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Zel Skin & Laser Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States
Facility Name
Laser & Dermatologic Surgery Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31809349
Citation
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.
Results Reference
result

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Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

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