Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Study Overview
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Brief Summary
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The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

Detailed Description
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Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects. The specific objectives of this study are to: Document the non-treated appearance of off-face SKs. Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion. Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.

Official Title
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Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis

Conditions
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Lesion Skin, Seborrheic Keratosis

Intervention / Treatment
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* Device: Nano-Pulse Stimulation (NPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign the informed consent Has a clinical diagnosis of stable, clinically typical seborrheic keratosis Medically determined candidate for at least 4 off-face SK lesions Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm Willing to have three of the designated SK lesions treated in a single treatment session Willing to return to the PI's office for five additional study visits at specified intervals over 106-days Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion No subject identity will be possible via the lesion-only photograph No evidence of active infection in the designated tissue prior to treatment Is not allergic to Lidocaine or Lidocaine-like products Not pregnant or lactating Exclusion Criteria: Has an implantable electronic device (e.g., automatic defibrillator) Active infection or history of infection within 90 previous days in designated test area Not willing or able to sign the Informed Consent Non-English speaking or reading Is known to be immune-compromised Known to be a keloid producer On blood thinning medications Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nano-Pulse Stimulation (NPS) Lesion<br>Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. | Device: Nano-Pulse Stimulation (NPS)<br>* The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.<br>|
| No Intervention: Non-Treated Lesion<br>One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of SK Lesions | Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site. | 106-day post-treatment | 

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