NCT04253418

Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study

Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Sebaceous Hyperplasia
• Skin Abnormalities
• Skin Lesion

Interventions

Type	Name	Description
DEVICE	Nano-Pulse Stimulation (NPS)	Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.

Timeline

• Start date: 2018-12-20
• Primary completion: 2020-05-14
• Completion: 2021-03-26
• First posted: 2020-02-05
• Last updated: 2023-10-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study