Clinical trial NCT03846531: Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
Official title: Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lesion Skin
Seborrheic Keratosis
Keywords: Nano-Pulse Stimulation
Seborrheic Keratosis
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clearance of SK Lesions
timeFrame: 106-day post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Premier Plastic Surgery
state: California
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin & Laser Specialists
state: Minnesota
city: Chesterfield
country: United States
facility: Laser & Dermatologic Surgery Center
state: Missouri
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Richard A Nuccitelli, PhD
role: STUDY_CHAIR
References:
citation: Hruza GJ, Zelickson BD, Selim MM, Rohrer TE, Newman J, Park H, Jauregui L, Nuccitelli R, Knape WA, Ebbers E, Uecker D. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses. Dermatol Surg. 2020 Sep;46(9):1183-1189. doi: 10.1097/DSS.0000000000002278.