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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 Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano-Pulse Stimulation (NPS) Treated Lesion | Experimental | Nano-Pulse Stimulation of target lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano-Pulse Stimulation (NPS) | Device | Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles. |
| Measure | Description | Time Frame |
|---|---|---|
| SH Lesion Clearance Rate | Clearance of SH lesions treated with NPS as rated by investigators. | 60-days post-last NPS 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 | ||
| Laser and Skin Surgery Center of Northern California |
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| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Sacramento |
| California |
| 95816 |
| United States |
| AVA MD | Santa Monica | California | 90404 | United States |
| Capital Laser & Skin Care | Chevy Chase | Maryland | 20815 | United States |
| United Skin Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |