Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study
Primary Purpose
Lesion Skin, Seborrheic Keratosis, Skin Lesion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nano-Pulse Stimulation (NPS)
Sponsored by
About this trial
This is an interventional treatment trial for Lesion Skin
Eligibility Criteria
Inclusion Criteria:
- Male or Female between 21 and 75 years of age
- Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
- Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits
- Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
- Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
- Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
- Minimum of two SK lesions
- SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
- Undergo all study procedures including consent for global photographs of the SK study sites
- Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion Criteria:
- Implantable electronic devices (i.e., automatic defibrillator)
- Active infection or history of infection in designated test area within 90 days prior to first treatment
- Not willing or able to sign the Informed Consent
- Known to be immune-compromised
- Known to be keloid producer
- Taking blood thinning medications
- Insulin dependent, Type I diabetics
- Allergies to Lidocaine or Lidocaine-like products
- Employed by the sponsor, clinic site, or entity associated with the conduct of the study
- Family member of someone employed by the sponsor, clinic site, or entity associated with the conduct of the study
- Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
- Prior inability to complete required study visits during treatment period.
- Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study
Sites / Locations
- Clear Dermatology & Aesthetics Center / InvestigateMD
- Mountain Dermatology Specialists
- SKIN Associates of South Florida
- Chicago Cosmetic Surgery and Dermatology
- Skin Care Physicians
- Zel Skin & Laser Specialists
- Dermatology, Laser & Vein Specialists of the Carolinas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nano-Pulse Stimulation (NPS) Treated Lesion
Arm Description
Nano-Pulse Stimulation of targeted lesion.
Outcomes
Primary Outcome Measures
Clearance Rate of SK Lesions
Degree of Clearance of SK lesion treated with NPS as rated by investigators.
Secondary Outcome Measures
Full Information
NCT ID
NCT04249115
First Posted
January 27, 2020
Last Updated
November 22, 2022
Sponsor
Pulse Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04249115
Brief Title
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study
Official Title
Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
August 13, 2020 (Actual)
Study Completion Date
April 22, 2021 (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
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
Detailed Description
Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
Evaluate skin effects and adverse event rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lesion Skin, Seborrheic Keratosis, Skin Lesion, Benign Skin Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nano-Pulse Stimulation (NPS) Treated Lesion
Arm Type
Experimental
Arm Description
Nano-Pulse Stimulation of targeted lesion.
Intervention Type
Device
Intervention Name(s)
Nano-Pulse Stimulation (NPS)
Intervention Description
Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.
Primary Outcome Measure Information:
Title
Clearance Rate of SK Lesions
Description
Degree of Clearance of SK lesion treated with NPS as rated by investigators.
Time Frame
90 days post-last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female between 21 and 75 years of age
Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits
Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
Minimum of two SK lesions
SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
Undergo all study procedures including consent for global photographs of the SK study sites
Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion Criteria:
Implantable electronic devices (i.e., automatic defibrillator)
Active infection or history of infection in designated test area within 90 days prior to first treatment
Not willing or able to sign the Informed Consent
Known to be immune-compromised
Known to be keloid producer
Taking blood thinning medications
Insulin dependent, Type I diabetics
Allergies to Lidocaine or Lidocaine-like products
Employed by the sponsor, clinic site, or entity associated with the conduct of the study
Family member of someone employed by the sponsor, clinic site, or entity associated with the conduct of the study
Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
Prior inability to complete required study visits during treatment period.
Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research 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
Clear Dermatology & Aesthetics Center / InvestigateMD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Mountain Dermatology Specialists
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
SKIN Associates of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Chicago Cosmetic Surgery and Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
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
Dermatology, Laser & Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study
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