Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/21/2019 |
Start Date: | May 4, 2017 |
End Date: | May 22, 2018 |
Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
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.
remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
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.
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.
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
We found this trial at
4
sites
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