Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia 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 Sebaceous Hyperplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04253418
• Other study ID #: NP-SH-009
• Status: Terminated
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: March 26, 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 Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: March 26, 2021
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Sebaceous Hyperplasia
• Skin Abnormalities
• Skin Lesion

Intervention

Device:
• Nano-Pulse Stimulation (NPS)
Electrical pulses (nanosecond duration) applied directly to target SH 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	United Skin Physicians	Chestnut Hill	Massachusetts
United States	Capital Laser & Skin Care	Chevy Chase	Maryland
United States	Laser and Skin Surgery Center of Northern California	Sacramento	California
United States	AVA MD	Santa Monica	California
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	SH Lesion Clearance Rate	Clearance of SH lesions treated with NPS as rated by investigators.	60-days post-last NPS treatment