Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study
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|ClinicalTrials.gov Identifier: NCT04253418|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sebaceous Hyperplasia Skin Abnormalities Skin Lesion||Device: Nano-Pulse Stimulation (NPS)||Not Applicable|
- Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
- Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
- Evaluate skin effects and adverse event rate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia|
|Actual Study Start Date :||February 20, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: Nano-Pulse Stimulation (NPS) Treated Lesion
Nano-Pulse Stimulation of target lesion.
Device: Nano-Pulse Stimulation (NPS)
Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.
- SH Lesion Clearance Rate [ Time Frame: 60-days post-last NPS treatment ]Clearance of SH lesions treated with NPS as rated by investigators.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253418
|United States, Arizona|
|Clear Dermatology & Aesthetics Center / InvestigateMD|
|Scottsdale, Arizona, United States, 85255|
|United States, California|
|Laser and Skin Surgery Center of Northern California|
|Sacramento, California, United States, 95816|
|Santa Monica, California, United States, 90404|
|United States, Maryland|
|Capital Laser & Skin Care|
|Chevy Chase, Maryland, United States, 20815|
|United States, Massachusetts|
|United Skin Physicians|
|Chestnut Hill, Massachusetts, United States, 02467|
|United States, North Carolina|
|Dermatology, Laser & Vein Specialists of the Carolinas|
|Charlotte, North Carolina, United States, 28207|
|Study Chair:||Richard A Nuccitelli, PhD||Pulse Biosciences, Inc.|