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N/A N=58 Single-blind Treatment

Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Lesion Skin · Seborrheic Keratosis

Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Clearance of SK Lesions — 82 percentage of SK lesion clearance

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Nano-Pulse Stimulation (NPS) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Pulse Biosciences, Inc.
Primary completion
Nov 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Clearance of SK Lesions
82

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03846531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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