Clinical trial NCT04253418: Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study
Official title: Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sebaceous Hyperplasia
Skin Abnormalities
Skin Lesion
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 125
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 Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.

Detailed description: * Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
* Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
* Evaluate skin effects and adverse event rate.

Eligibility criteria: Inclusion Criteria:

* Male or Female between 18 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 are willing to return for all the required follow-up visits.
* Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit
* Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment.
* Clinically diagnosis of typical sebaceous hyperplasia.
* Minimum of four SH lesions.
* Undergo all study procedures including consent for photographs of the treated SH sites.
* Agrees to refrain from using all other SH lesion removal products or treatments (topical medication including over-the-counter medications) during the study period.

Exclusion Criteria:

* Implantable electronic devices (i.e., pacemaker, implantable cardioverter 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 a 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.
* 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.
* Known 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: SH Lesion Clearance Rate
timeFrame: 60-days post-last NPS treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center / InvestigateMD
state: Arizona
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
city: Santa Monica
country: United States
facility: AVA MD
state: California
city: Chevy Chase
country: United States
facility: Capital Laser & Skin Care
state: Maryland
city: Chestnut Hill
country: United States
facility: United Skin Physicians
state: Massachusetts
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: