Trial Outcomes & Findings for Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study (NCT NCT03846531)

NCT ID: NCT03846531

Last Updated: 2023-08-22

Results Overview

Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 106-day post-treatment
• Results posted on: 2023-08-22

Participant Flow

A total of 4 SK study lesions were enrolled per subject, one SK lesion was randomized to be an internal subject control and the 3 other SK lesions were pre-assigned for treatment for a total of 232 study lesions; 58 Controls and 174 Treated lesions.

Unit of analysis: SK lesions

Participant milestones

Measure	Nano-Pulse Stimulation (NPS) Treatment Arm Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. 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.
Overall Study STARTED	58 174
Overall Study COMPLETED	58 174
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Baseline characteristics by cohort

Measure	Nano-Pulse Stimulation (NPS) Lesion n=174 SK lesions Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. 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.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 106-day post-treatment

Population: Fifty-eight (58) participants with each participant having a total of 4 SK lesions, 3 treated and 1 serving as an internal untreated control.

Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.

Outcome measures

Measure	Nano-Pulse Stimulation (NPS) Lesion n=174 SK lesions Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. 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.
Clearance of SK Lesions	82 percentage of SK lesion clearance

Adverse Events

Nano-Pulse Stimulation (NPS) Treatment Arm

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nano-Pulse Stimulation (NPS) Treatment Arm n=58 participants at risk Three of four selected SK lesions received Nano-Pulse Stimulation treatment. 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.
Skin and subcutaneous tissue disorders Transient Hyperpigmentation	60.3% 35/58 • Number of events 35 • 3.5 months (106 days)

Additional Information

William A. Knape

Pulse Biosciences, Inc.

Phone: (510) 906-4649

Email: bill.knape@pulsebiosciences.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60