Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Completed · Not applicable

Conditions studied: Lesion Skin, Seborrheic Keratosis

In brief

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.

Key facts

Study ID: NCT03846531
Run by: Pulse Biosciences, Inc.
People needed: 58
Starts: 2017-05-04
Expected to finish: 2018-05-22
Last updated by the study team: 2023-08-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Premier Plastic Surgery — San Mateo, California, United States
Skin Care Physicians — Chestnut Hill, Massachusetts, United States
Zel Skin & Laser Specialists — Edina, Minnesota, United States
Laser & Dermatologic Surgery Center — Chesterfield, Missouri, United States

Full record on ClinicalTrials.gov

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