NCT04249115

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (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 Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.

Detailed description

* Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles. * Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline. * Evaluate skin effects and adverse event rate.

Conditions

• Lesion Skin
• Seborrheic Keratosis
• Skin Lesion
• Benign Skin Tumor

Interventions

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

Timeline

• Start date: 2019-02-05
• Primary completion: 2020-08-13
• Completion: 2021-04-22
• First posted: 2020-01-30
• Last updated: 2023-10-30

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study