Benign Skin Tumor, Lesion Skin, Seborrheic Keratosis, Skin Lesion
Conditions
Brief summary
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
Detailed description
* Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles. * Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline. * Evaluate skin effects and adverse event rate.
Interventions
Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female between 21 and 75 years of age * Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained * Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits * Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment * Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment * Clinical diagnosis of stable, clinically typical Seborrheic Keratosis * Minimum of two SK lesions * SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point * Undergo all study procedures including consent for global photographs of the SK study sites * Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion criteria
* Implantable electronic devices (i.e., automatic defibrillator) * Active infection or history of infection in designated test area within 90 days prior to first treatment * Not willing or able to sign the Informed Consent * Known to be immune-compromised * Known to be keloid producer * Taking blood thinning medications * Insulin dependent, Type I diabetics * Allergies to Lidocaine or Lidocaine-like products * Employed by the sponsor, clinic site, or entity associated with the conduct of the study * Family member of someone employed by the sponsor, clinic site, or entity associated with the conduct of the study * Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study * Prior inability to complete required study visits during treatment period. * Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance Rate of SK Lesions | 90 days post-last treatment | Degree of Clearance of SK lesion treated with NPS as rated by investigators. |
Countries
United States
Outcome results
None listed