Lesion SkinNCT04249115
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study
A study testing Nano-Pulse Stimulation (NPS) in people with Lesion Skin and Seborrheic Keratosis, run by Pulse Biosciences, Inc. at 7 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 Seborrheic Keratosis (SKs) from off-facial areas of healthy adults. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Lesion Skin, Seborrheic Keratosis, 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
- 175 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Feb 2019to 22 Apr 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 21 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 willing to return for all the required follow-up visits
- Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
- Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
- Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
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- Minimum of two SK lesions
- SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
- Undergo all study procedures including consent for global photographs of the SK study sites
- Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period
Who cannot join
- Implantable electronic devices (i.e., automatic 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 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
- Family member of someone 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
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
SKIN Associates of South Florida
Coral Gables, Florida, 33146
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
Mountain Dermatology Specialists
Edwards, Colorado, 81632
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 Seborrheic Keratosis
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
Read the detailed description
- Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
- Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
- Evaluate skin effects and adverse event rate.
- Conditions
- Lesion Skin, Seborrheic Keratosis, Skin Lesion, Benign Skin Tumor
- Being tested
- Nano-Pulse Stimulation (NPS)
- Medical subject headings
- Keratosis, Seborrheic
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 SK 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 targeted lesion. Receives: Device: Nano-Pulse Stimulation (NPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance Rate of SK Lesions
Degree of Clearance of SK lesion treated with NPS as rated by investigators.
Measured: 90 days 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 posted30 Jan 2020
- Study start5 Feb 2019
- Primary completion13 Aug 2020
- Study completion22 Apr 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 Lesion SkinStudies 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
- 175 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
- NCT04249115
- Sponsor's protocol ID
- NP-SK-008
- Status last verified
- Oct 2023
- First submitted
- 27 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 Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT04249115
- Acronym / sponsor ID
- NP-SK-008
- Conditions
- Lesion Skin, Seborrheic Keratosis, Skin Lesion, Benign Skin Tumor
- 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
- 175 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 30 Jan 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 Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
Detailed description
- Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
- Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
- 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 targeted lesion. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female between 21 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 willing to return for all the required follow-up visits
- Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
- Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
Key exclusion criteria (13 listed)
- Implantable electronic devices (i.e., automatic 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 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 SK lesions using sterile single-patient use treatment tips with microneedles. | Device | Nano-Pulse Stimulation (NPS) Treated Lesion |
Primary outcome
Clearance Rate of SK Lesions
Time frame: 90 days post-last treatment
Degree of Clearance of SK lesion 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
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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 A Nuccitelli, PhD study chair
Pulse Biosciences, Inc.
7 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 Lesion Skin and Seborrheic Keratosis, run by Pulse Biosciences, Inc. at 7 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 10 inclusion and 13 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 7 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?
Clearance Rate of SK Lesions (time frame: 90 days post-last 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; AzTrials last refreshed its copy on 30 Oct 2026.