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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253418
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Pulse Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Sebaceous Hyperplasia Skin Abnormalities Skin Lesion Device: Nano-Pulse Stimulation (NPS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 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 Sebaceous Hyperplasia
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Nano-Pulse Stimulation (NPS) Treated Lesion
Nano-Pulse Stimulation of target lesion.
Device: Nano-Pulse Stimulation (NPS)
Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.




Primary Outcome Measures :
  1. SH Lesion Clearance Rate [ Time Frame: 60-days post-last NPS treatment ]
    Clearance of SH lesions treated with NPS as rated by investigators.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253418


Locations
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United States, Arizona
Clear Dermatology & Aesthetics Center / InvestigateMD
Scottsdale, Arizona, United States, 85255
United States, California
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
AVA MD
Santa Monica, California, United States, 90404
United States, Maryland
Capital Laser & Skin Care
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
United Skin Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Pulse Biosciences, Inc.
Investigators
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Study Chair: Richard A Nuccitelli, PhD Pulse Biosciences, Inc.
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Responsible Party: Pulse Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04253418    
Other Study ID Numbers: NP-SH-009
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Skin Abnormalities
Hyperplasia
Congenital Abnormalities
Pathologic Processes
Skin Diseases