An interventional study of Nano-Pulse Stimulation Device in Skin Lesion, Skin Abnormalities and Sebaceous Hyperplasia, sponsored by Pulse Biosciences, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Pulse Biosciences, Inc. · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
This study's enrollment of 72 is above the median of 39 across 26 interventional studies indexed under Skin Abnormalities.
Browse Skin Abnormalities studies →Pulse Biosciences, Inc. is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nano-Pulse Stimulation Device using pre-defined energy protocol
Device: 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.
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
| Milestone | Number of Study Participants |
|---|---|
| Started | 72 |
| Completed | 71 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| Percentage of cleared SH Lesions | Total Number of Cleared Lesions With Sebaceous Hyperplasia (SH) |
|---|---|
| Total Number of Cleared SH Lesions | 99.5 |
Collected over Skin effects (hyperpigmentation) were observed per SH lesion at the 5-day, 30-day, 60-day and if applicable 90-day follow-up periods.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NPS Treated Sebaceous Hyperplasia (SH) Lesion | 0/71 (0%) | 0/71 (0%) | 32/71 (45.1%) |
| Event | NPS Treated Sebaceous Hyperplasia (SH) Lesion |
|---|---|
| Post-Inflammatory HyperpigmentationSkin and subcutaneous tissue disorders | 32/71 |
One Participant was not seen at follow-up after being treated or enrolled into the study.
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 55 (31 to 71) |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 56 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 71 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 69 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 72 |
Plan to share: No
Ran from Jun 2018 to primary completion in Sep 2018, 2 months.
Results were first posted in Apr 2024, 5 years 7 months after primary completion.
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Pulse Biosciences, Inc.