NCT03612570

Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

Detailed description

The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

Conditions

• Skin Lesion
• Skin Abnormalities
• Sebaceous Hyperplasia

Interventions

Type	Name	Description
DEVICE	Nano-Pulse Stimulation Device	NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.

Timeline

• Start date: 2018-06-28
• Primary completion: 2018-09-05
• Completion: 2018-11-28
• First posted: 2018-08-02
• Last updated: 2024-04-12
• Results posted: 2024-04-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study