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Completed

NCT Number: NCT03846531

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

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.

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Key information

Conditions

Lesion Skin Keratosis Keratosis, Seborrheic Seborrheic Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Premier Plastic Surgery, San Mateo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Clearance of SK Lesions

    Time frame: 106-day post-treatment

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

Sponsors and collaborators

Lead sponsor

Pulse Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 19, 2019
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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