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Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study

Sponsor
Pulse Biosciences, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04249115
Collaborator
(none)
175
Enrollment
7
Locations
1
Arm
28.7
Anticipated Duration (Months)
25
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nano-Pulse Stimulation (NPS)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis
Actual Study Start Date :
Feb 7, 2019
Actual Primary Completion Date :
Aug 13, 2020
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nano-Pulse Stimulation (NPS) Treated Lesion

Nano-Pulse Stimulation of targeted lesion.

Device: Nano-Pulse Stimulation (NPS)
Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.

Outcome Measures

Primary Outcome Measures

  1. Clearance Rate of SK Lesions [90 days post-last treatment]

    Degree of Clearance of SK lesion treated with NPS as rated by investigators.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clear Dermatology & Aesthetics Center / InvestigateMD Scottsdale Arizona United States 85255
2 Mountain Dermatology Specialists Edwards Colorado United States 81632
3 SKIN Associates of South Florida Coral Gables Florida United States 33146
4 Chicago Cosmetic Surgery and Dermatology Chicago Illinois United States 60654
5 Skin Care Physicians Chestnut Hill Massachusetts United States 02467
6 Zel Skin & Laser Specialists Edina Minnesota United States 55424
7 Dermatology, Laser & Vein Specialists of the Carolinas Charlotte North Carolina United States 28207

Sponsors and Collaborators

  • Pulse Biosciences, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pulse Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT04249115
Other Study ID Numbers:
  • NP-SK-008
First Posted:
Jan 30, 2020
Last Update Posted:
Jun 2, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis
Keratosis, Seborrheic

Study Results

No Results Posted as of Jun 2, 2021