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

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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.

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.

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
Chestnut Hill, Massachusetts 02467
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Chestnut Hill, MA
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Chesterfield, Missouri 63017
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Chesterfield, MO
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Edina, Minnesota 55424
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Edina, MN
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San Mateo, California 94401
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San Mateo, CA
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