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

Stopped early · Not applicable

Conditions studied: Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion

In brief

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.

Key facts

Study ID

NCT04253418

Run by

Pulse Biosciences, Inc.

People needed

125

Starts

2018-12-20

Expected to finish

2021-03-26

Last updated by the study team

2023-10-30

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clear Dermatology & Aesthetics Center / InvestigateMD — Scottsdale, Arizona, United States
• Laser and Skin Surgery Center of Northern California — Sacramento, California, United States
• AVA MD — Santa Monica, California, United States
• Capital Laser & Skin Care — Chevy Chase, Maryland, United States
• United Skin Physicians — Chestnut Hill, Massachusetts, United States
• Dermatology, Laser & Vein Specialists of the Carolinas — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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