NCT03846531

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

Detailed description

Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects. The specific objectives of this study are to: * Document the non-treated appearance of off-face SKs. * Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion. * Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.

Conditions

• Lesion Skin
• Seborrheic Keratosis

Interventions

Type	Name	Description
DEVICE	Nano-Pulse Stimulation (NPS)	The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Timeline

• Start date: 2017-05-04
• Primary completion: 2017-11-13
• Completion: 2018-05-22
• First posted: 2019-02-19
• Last updated: 2023-08-22
• Results posted: 2023-08-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study