Trial Outcomes & Findings for Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia (NCT NCT03612570)
NCT ID: NCT03612570
Last Updated: 2024-04-12
Results Overview
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.
COMPLETED
NA
72 participants
60-days follow-up post-last treatment
2024-04-12
Participant Flow
Unit of analysis: SH Lesions
Participant milestones
| Measure |
Number of Study Participants
Total Number of Participants with Sebaceous Hyperplastic Lesions treated with Nano-Pulse Stimulation (NPS) using a pre-defined energy protocol.
|
|---|---|
|
Overall Study
STARTED
|
72 226
|
|
Overall Study
COMPLETED
|
71 222
|
|
Overall Study
NOT COMPLETED
|
1 4
|
Reasons for withdrawal
| Measure |
Number of Study Participants
Total Number of Participants with Sebaceous Hyperplastic Lesions treated with Nano-Pulse Stimulation (NPS) using a pre-defined energy protocol.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Baseline characteristics by cohort
| Measure |
All Participants
n=72 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.
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|---|---|
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Age, Continuous
|
55 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60-days follow-up post-last treatmentPopulation: Total number of treated SH Lesions at 60-days.
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.
Outcome measures
| Measure |
Total Number of Cleared Lesions With Sebaceous Hyperplasia (SH)
n=222 SH lesions
Total Number of Lesions with Sebaceous Hyperplasia (SH) that were treated with Nano-Pulse Stimulation (NPS) using a pre-defined energy protocol
|
|---|---|
|
Total Number of Cleared SH Lesions
|
99.5 Percentage of cleared SH Lesions
|
Adverse Events
NPS Treated Sebaceous Hyperplasia (SH) Lesion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPS Treated Sebaceous Hyperplasia (SH) Lesion
n=71 participants at risk
Nano-Pulse Stimulation (NPS) treated SH Lesions using pre-defined treatment levels. All adverse events were recorded per lesion.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Post-Inflammatory Hyperpigmentation
|
45.1%
32/71 • Number of events 32 • Skin effects (hyperpigmentation) were observed per SH lesion at the 5-day, 30-day, 60-day and if applicable 90-day follow-up periods.
Skin effects per SH lesion were defined as presence of mild, moderate or severe post-inflammatory hyperpigmentation (PIH).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60