Clinical trial NCT04249115: 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
Overall status: TERMINATED
Phase: NA
Conditions: Lesion Skin
Seborrheic Keratosis
Skin Lesion
Benign Skin Tumor
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 175
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clearance Rate of SK Lesions
timeFrame: 90 days post-last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center / InvestigateMD
state: Arizona
city: Edwards
country: United States
facility: Mountain Dermatology Specialists
state: Colorado
city: Coral Gables
country: United States
facility: SKIN Associates of South Florida
state: Florida
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin & Laser Specialists
state: Minnesota
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Richard A Nuccitelli, PhD
role: STUDY_CHAIR
References: