Skin LesionNCT03612570
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
A study testing Nano-Pulse Stimulation Device in people with Skin Lesion and Skin Abnormalities, run by Pulse Biosciences, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
- What is being tested?
- Nano-Pulse Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jun 2018to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
Laser & Skin Surgery Medical Group, Inc.
Sacramento, California, 95816
Premier Plastic Surgery
San Mateo, California, 94401
About this study
Official title: Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
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.
Read the 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.
- Conditions
- Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
- Being tested
- Nano-Pulse Stimulation Device
- Keywords
- Nano-Pulse Stimulation, NPS
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-Pulse Stimulation DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NPS Treated SH Lesion | Experimental | Nano-Pulse Stimulation Device using pre-defined energy protocol Receives: Device: Nano-Pulse Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60-days follow-up post-last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start28 Jun 2018
- Primary completion5 Sep 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Nuccitelli, PhD, Study chair, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612570
- Sponsor's protocol ID
- NP-SH-006
- Status last verified
- Apr 2024
- First submitted
- 27 Jul 2018
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, Rohrer TE, Newman J, Jauregui L, Knape WA, Ebbers E, Uecker D, Nuccitelli R. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia. Dermatol Surg. 2020 Jun;46(6):803-809. doi: 10.1097/DSS.0000000000002154.
PubMed 31592824
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
- ClinicalTrials.gov ID
- NCT03612570
- Acronym / sponsor ID
- NP-SH-006
- Conditions
- Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
- Keywords
- Nano-Pulse Stimulation, NPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPS Treated SH Lesion | Experimental | Device: Nano-Pulse Stimulation DeviceNano-Pulse Stimulation Device using pre-defined energy protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-Pulse Stimulation DeviceNPS 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. | Device | NPS Treated SH Lesion |
Primary outcome
Total Number of Cleared SH Lesions
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31592824Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, Rohrer TE, Newman J, Jauregui L, Knape WA, Ebbers E, Uecker D, Nuccitelli R. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia. Dermatol Surg. 2020 Jun;46(6):803-809. doi: 10.1097/DSS.0000000000002154.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Nuccitelli, PhD study chair
Pulse Biosciences, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-Pulse Stimulation Device in people with Skin Lesion and Skin Abnormalities, run by Pulse Biosciences, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Cleared SH Lesions (time frame: 60-days follow-up post-last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.