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Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.
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Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano-Pulse Stimulation (NPS) Treated Lesion | Experimental | Nano-Pulse Stimulation of targeted lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano-Pulse Stimulation (NPS) | Device | Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance Rate of SK Lesions | Degree of Clearance of SK lesion treated with NPS as rated by investigators. | 90 days post-last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Nuccitelli, PhD | Pulse Biosciences, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clear Dermatology & Aesthetics Center / InvestigateMD | Scottsdale | Arizona | 85255 | United States | ||
| Mountain Dermatology Specialists |
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| ID | Term |
|---|---|
| D017492 | Keratosis, Seborrheic |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Edwards |
| Colorado |
| 81632 |
| United States |
| SKIN Associates of South Florida | Coral Gables | Florida | 33146 | United States |
| Chicago Cosmetic Surgery and Dermatology | Chicago | Illinois | 60654 | United States |
| Skin Care Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| Zel Skin & Laser Specialists | Edina | Minnesota | 55424 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |