Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

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

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.

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.

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