Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Study Overview
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Brief Summary
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This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

Detailed Description
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The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. One lesion will be randomized as a untreated control and no NPS energy will be delivered. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

Official Title
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Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Conditions
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Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

Intervention / Treatment
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* Device: Nano-Pulse Stimulation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females Presents with at least 2 and up to 5 clinically visible SH lesions Understands that 1 lesion will remain untreated to act as a reference Lesions must measure no greater than 2.5 x 2.5 at the outside margin Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion Selection of the non-treated reference lesion will be randomly identified Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days Agrees to photographic or other image capture methods of both the treated and untreated lesions. Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days Is not allergic to Lidocaine or Lidocaine-like products Exclusion Criteria: Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device SH lesions are located within the eye orbit or on the nose Active infection or history of infection in designated test area within 90 days prior to study initiation Use of oral steroid and/or retinoid use within the last 12 months Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start Taking blood thinning medications Has Insulin dependent diabetes Is known to be pregnant or lactating female

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPS Treated SH Lesion<br>Nano-Pulse Stimulation Device using pre-defined energy protocol | Device: Nano-Pulse Stimulation Device<br>* NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Clearance | At least 50% of the NPS treated lesions will be rated as CLEAR or MOSTLY CLEAR | 60-day Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nano-Pulse Stimulation, NPS