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.
* 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.
Clear Dermatology & Aesthetics Center / InvestigateMD
Scottsdale, Arizona, United States
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States
AVA MD
Santa Monica, California, United States
Capital Laser & Skin Care
Chevy Chase, Maryland, United States
SH Lesion Clearance Rate
Clearance of SH lesions treated with NPS as rated by investigators.
Time frame: 60-days post-last NPS treatment
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United Skin Physicians
Chestnut Hill, Massachusetts, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States