Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano-Pulse Stimulation (NPS) Lesion | Active Comparator | Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. |
|
| Non-Treated Lesion | No Intervention | One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano-Pulse Stimulation (NPS) | Device | The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard A Nuccitelli, PhD | Pulse Biosciences, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Plastic Surgery | San Mateo | California | 94401 | United States | ||
| Skin Care Physicians |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31809349 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 4 SK study lesions were enrolled per subject, one SK lesion was randomized to be an internal subject control and the 3 other SK lesions were pre-assigned for treatment for a total of 232 study lesions; 58 Controls and 174 Treated lesions.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nano-Pulse Stimulation (NPS) Treatment Arm | Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Analysis Population includes 58 Participants with 3 treated SK lesions and one SK lesion as an internal control for a total of 4 SK lesions per participants.
| ID | Title | Description |
|---|---|---|
| BG000 | Nano-Pulse Stimulation (NPS) Lesion | Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Fifty-eight (58) participants with each participant having a total of 4 SK lesions, 3 treated and 1 serving as an internal untreated control. | Posted | Number | percentage of SK lesion clearance | 106-day post-treatment | SK lesions | SK lesions |
|
3.5 months (106 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nano-Pulse Stimulation (NPS) Treatment Arm | Three of four selected SK lesions received Nano-Pulse Stimulation treatment. Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment | Skin hyperpigmentation at the site of treated lesion |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William A. Knape | Pulse Biosciences, Inc. | (510) 906-4649 | bill.knape@pulsebiosciences.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2017 | Jul 31, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017492 | Keratosis, Seborrheic |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
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.
Not provided
Not provided
A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.
| Chestnut Hill |
| Massachusetts |
| 02467 |
| United States |
| Zel Skin & Laser Specialists | Edina | Minnesota | 55424 | United States |
| Laser & Dermatologic Surgery Center | Chesterfield | Missouri | 63017 | United States |
| SK lesions |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| SK lesions |
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 35 |
| 58 |
|
Not provided