N/A
N=58
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
Lesion Skin · Seborrheic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT03846531 ↗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
| Outcome | Result | p-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
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.