Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study (NCT03846531) | Clinical Trial Compass
CompletedNot Applicable
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
United States58 participantsStarted 2017-05-04
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 P…