Sebaceous HyperplasiaNCT04253418
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study
A study testing Nano-Pulse Stimulation (NPS) in people with Sebaceous Hyperplasia and Skin Abnormalities, run by Pulse Biosciences, Inc. at 6 sites in United States.
Trial summary
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion
- What is being tested?
- Nano-Pulse Stimulation (NPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Dec 2018to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female between 18 and 75 years of age
- Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Understanding of the clinical investigation, agree to cooperate with the investigational procedures and are willing to return for all the required follow-up visits.
- Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit
- Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment.
- Clinically diagnosis of typical sebaceous hyperplasia.
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- Minimum of four SH lesions.
- Undergo all study procedures including consent for photographs of the treated SH sites.
- Agrees to refrain from using all other SH lesion removal products or treatments (topical medication including over-the-counter medications) during the study period.
Who cannot join
- Implantable electronic devices (i.e., pacemaker, implantable cardioverter defibrillator)
- Active infection or history of infection in designated test area within 90 days prior to first treatment.
- Not willing or able to sign the Informed Consent.
- Known to be immune-compromised.
- Known to be a keloid producer.
- Taking blood thinning medications.
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- Insulin dependent, Type I diabetics.
- Allergies to Lidocaine or Lidocaine-like products.
- Employed by the sponsor, clinic site, or entity associated with the conduct of the study.
- Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
- Known prior inability to complete required study visits during treatment period.
- Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
United Skin Physicians
Chestnut Hill, Massachusetts, 02467
Capital Laser & Skin Care
Chevy Chase, Maryland, 20815
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
AVA MD
Santa Monica, California, 90404
Clear Dermatology & Aesthetics Center / InvestigateMD
Scottsdale, Arizona, 85255
About this study
Official title: Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.
Read the detailed description
- Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
- Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
- Evaluate skin effects and adverse event rate.
- Conditions
- Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion
- Being tested
- 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 (NPS)Device
Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.
| Study group | Role | What they receive |
|---|---|---|
| Nano-Pulse Stimulation (NPS) Treated Lesion | Experimental | Nano-Pulse Stimulation of target lesion. Receives: Device: Nano-Pulse Stimulation (NPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SH Lesion Clearance Rate
Clearance of SH lesions treated with NPS as rated by investigators.
Measured: 60-days post-last NPS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Dec 2018
- Primary completion14 May 2020
- Study completion26 Mar 2021
Why it stopped: Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sebaceous HyperplasiaStudies 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A Nuccitelli, PhD, Study chair, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253418
- Sponsor's protocol ID
- NP-SH-009
- Status last verified
- Oct 2023
- First submitted
- 28 Jan 2020
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia
- ClinicalTrials.gov ID
- NCT04253418
- Acronym / sponsor ID
- NP-SH-009
- Conditions
- Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.
Detailed description
- Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
- Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
- Evaluate skin effects and adverse event rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nano-Pulse Stimulation (NPS) Treated Lesion | Experimental | Device: Nano-Pulse Stimulation (NPS)Nano-Pulse Stimulation of target lesion. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female between 18 and 75 years of age
- Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Understanding of the clinical investigation, agree to cooperate with the investigational procedures and are willing to return for all the required follow-up visits.
- Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit
- Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment.
Key exclusion criteria (12 listed)
- Implantable electronic devices (i.e., pacemaker, implantable cardioverter defibrillator)
- Active infection or history of infection in designated test area within 90 days prior to first treatment.
- Not willing or able to sign the Informed Consent.
- Known to be immune-compromised.
- Known to be a keloid producer.
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 (NPS)Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles. | Device | Nano-Pulse Stimulation (NPS) Treated Lesion |
Primary outcome
SH Lesion Clearance Rate
Time frame: 60-days post-last NPS treatment
Clearance of SH lesions treated with NPS as rated by investigators.
Results and safety
The study was stopped early (reason given: Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Sebaceous Hyperplasia
Enrolling by invitationPhase 2
Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Sebaceous Hyperplasia
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 A Nuccitelli, PhD study chair
Pulse Biosciences, Inc.
6 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 (NPS) in people with Sebaceous Hyperplasia and Skin Abnormalities, run by Pulse Biosciences, Inc. at 6 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study was stopped early (reason given: Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.). Results are not available in the source record.
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?
SH Lesion Clearance Rate (time frame: 60-days post-last NPS treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2023.