Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Pulse Biosciences

Status

Completed

Conditions

Lesion Skin

Seborrheic Keratosis

Treatments

Device: Nano-Pulse Stimulation (NPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03846531

NP-SK-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

58 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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