Lesion Skin, Seborrheic Keratosis
Conditions
Keywords
Nano-Pulse Stimulation, Seborrheic Keratosis
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 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.
Interventions
The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.
Intervention model description
Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of SK Lesions | 106-day post-treatment | Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site. |
Countries
United States
Participant flow
Pre-assignment details
A total of 4 SK study lesions were enrolled per subject, one SK lesion was randomized to be an internal subject control and the 3 other SK lesions were pre-assigned for treatment for a total of 232 study lesions; 58 Controls and 174 Treated lesions.
Participants by arm
| Arm | Count |
|---|---|
| Nano-Pulse Stimulation (NPS) Lesion Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.
Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. | 58 |
| Nano-Pulse Stimulation (NPS) Lesion Three of four selected SK lesions receive Nano-Pulse Stimulation treatment.
Nano-Pulse Stimulation (NPS): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. | 174 |
| Total | 232 |
Baseline characteristics
| Characteristic | Nano-Pulse Stimulation (NPS) Lesion |
|---|---|
| Age, Continuous | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 35 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
Clearance of SK Lesions
Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.
Time frame: 106-day post-treatment
Population: Fifty-eight (58) participants with each participant having a total of 4 SK lesions, 3 treated and 1 serving as an internal untreated control.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nano-Pulse Stimulation (NPS) Lesion | Clearance of SK Lesions | 82 percentage of SK lesion clearance |