Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion
Conditions
Keywords
Nano-Pulse Stimulation, NPS
Brief summary
This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.
Detailed description
The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.
Interventions
DEVICENano-Pulse Stimulation Device
NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males or females * Presents with at least 2 and up to 5 clinically visible SH lesions * Understands that 1 lesion will remain untreated to act as a reference * Lesions must measure no greater than 2.5 x 2.5 at the outside margin * Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion * Selection of the non-treated reference lesion will be randomly identified * Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days * Agrees to photographic or other image capture methods of both the treated and untreated lesions. * Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study * Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days * Is not allergic to Lidocaine or Lidocaine-like products
Exclusion criteria
* Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator * Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device * SH lesions are located within the eye orbit or on the nose * Active infection or history of infection in designated test area within 90 days prior to study initiation * Use of oral steroid and/or retinoid use within the last 12 months * Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start * Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start * Taking blood thinning medications * Has Insulin dependent diabetes * Is known to be pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Cleared SH Lesions | 60-days follow-up post-last treatment | SH lesion clearance was assessed live by investigators for each treated SH lesion (n=222) at 60-days post-last treatment using a 4-point scale (i.e., 0, 1, 2, 3) where each number corresponded to Clear, Mostly Clear, Partially Clear, or Not Clear, respectively. Lower scores mean better outcome, i.e., 0=Clear while a 3=Not Clear. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Nano-Pulse Stimulation Device using pre-defined energy protocol
Nano-Pulse Stimulation Device: NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 55 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 32 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Total Number of Cleared SH Lesions
SH lesion clearance was assessed live by investigators for each treated SH lesion (n=222) at 60-days post-last treatment using a 4-point scale (i.e., 0, 1, 2, 3) where each number corresponded to Clear, Mostly Clear, Partially Clear, or Not Clear, respectively. Lower scores mean better outcome, i.e., 0=Clear while a 3=Not Clear.
Time frame: 60-days follow-up post-last treatment
Population: Total number of treated SH Lesions at 60-days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Number of Cleared Lesions With Sebaceous Hyperplasia (SH) | Total Number of Cleared SH Lesions | 99.5 Percentage of cleared SH Lesions |