Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

NCT03846531 | Completed Results FDA Device

• 1 other identifier: NP-SK-002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Lesion Skin; Seborrheic Keratosis

Keywords

Nano-Pulse Stimulation; Seborrheic Keratosis

Outcome Measures

Primary Outcomes (1)

• Clearance of SK Lesions

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

  106-day post-treatment

Study Arms (2)

Nano-Pulse Stimulation (NPS) Lesion

ACTIVE COMPARATOR

Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.

Device: Nano-Pulse Stimulation (NPS)

Non-Treated Lesion

NO INTERVENTION

One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment.

Interventions

Nano-Pulse Stimulation (NPS) DEVICE

The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Nano-Pulse Stimulation (NPS) Lesion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the informed consent
• Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
• Medically determined candidate for at least 4 off-face SK lesions
• Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
• Willing to have three of the designated SK lesions treated in a single treatment session
• Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
• Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
• No subject identity will be possible via the "lesion-only" photograph
• No evidence of active infection in the designated tissue prior to treatment
• Is not allergic to Lidocaine or Lidocaine-like products
• Not pregnant or lactating

You may not qualify if:

• Has an implantable electronic device (e.g., automatic defibrillator)
• Active infection or history of infection within 90 previous days in designated test area
• Not willing or able to sign the Informed Consent
• Non-English speaking or reading
• Is known to be immune-compromised
• Known to be a keloid producer
• On blood thinning medications
• Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (4)

Premier Plastic Surgery

San Mateo, California, 94401, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Zel Skin & Laser Specialists

Edina, Minnesota, 55424, United States

Location

Laser & Dermatologic Surgery Center

Chesterfield, Missouri, 63017, United States

Location

Related Publications (1)

• Hruza GJ, Zelickson BD, Selim MM, Rohrer TE, Newman J, Park H, Jauregui L, Nuccitelli R, Knape WA, Ebbers E, Uecker D. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses. Dermatol Surg. 2020 Sep;46(9):1183-1189. doi: 10.1097/DSS.0000000000002278.

  PMID: 31809349 RESULT

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: William A. Knape
• Organization: Pulse Biosciences, Inc.

bill.knape@pulsebiosciences.com

(510) 906-4649

Study Officials

• Richard A Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: February 19, 2019
• Study Start: May 4, 2017
• Primary Completion: November 13, 2017
• Study Completion: May 22, 2018
• Last Updated: August 22, 2023
• Results First Posted: August 22, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)