Status:
COMPLETED
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
Lead Sponsor:
Pulse Biosciences, Inc.
Conditions:
Lesion Skin
Seborrheic Keratosis
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03846531
Start Date
May 4 2017
End Date
May 22 2018
Last Update
August 22 2023
Active Locations (4)
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1
Premier Plastic Surgery
San Mateo, California, United States, 94401
2
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
3
Zel Skin & Laser Specialists
Edina, Minnesota, United States, 55424
4
Laser & Dermatologic Surgery Center
Chesterfield, Missouri, United States, 63017