Seborrheic Keratosis Clinical Trial
Official title:
Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
NCT number | NCT03846531 |
Other study ID # | NP-SK-002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2017 |
Est. completion date | May 22, 2018 |
Verified date | July 2023 |
Source | Pulse Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | May 22, 2018 |
Est. primary completion date | November 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Laser & Dermatologic Surgery Center | Chesterfield | Missouri |
United States | Skin Care Physicians | Chestnut Hill | Massachusetts |
United States | Zel Skin & Laser Specialists | Edina | Minnesota |
United States | Premier Plastic Surgery | San Mateo | California |
Lead Sponsor | Collaborator |
---|---|
Pulse Biosciences, Inc. |
United States,
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: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clearance of SK Lesions | Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site. | 106-day post-treatment |
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