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

Skin Lesion Clinical Trial

Official title:

Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04249115
• Other study ID #: NP-SK-008
• Status: Terminated
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: April 22, 2021

Study information

• Verified date: October 2023
• Source: Pulse Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: April 22, 2021
• Est. primary completion date: August 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Skin Tumor
• Keratosis
• Keratosis, Actinic
• Keratosis, Seborrheic
• Lesion Skin
• Seborrheic Keratosis
• Skin Lesion

Intervention

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

Locations

Country	Name	City	State
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Skin Care Physicians	Chestnut Hill	Massachusetts
United States	Chicago Cosmetic Surgery and Dermatology	Chicago	Illinois
United States	SKIN Associates of South Florida	Coral Gables	Florida
United States	Zel Skin & Laser Specialists	Edina	Minnesota
United States	Mountain Dermatology Specialists	Edwards	Colorado
United States	Clear Dermatology & Aesthetics Center / InvestigateMD	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pulse Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance Rate of SK Lesions	Degree of Clearance of SK lesion treated with NPS as rated by investigators.	90 days post-last treatment