Lesion SkinNCT03846531
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
A study testing Nano-Pulse Stimulation (NPS) in people with Lesion Skin and Seborrheic Keratosis, run by Pulse Biosciences, Inc. at 4 sites in United States.
Trial summary
The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lesion Skin, Seborrheic Keratosis
- 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
- 58 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 May 2017to 22 May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to sign the informed consent
- Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
- Medically determined candidate for at least 4 off-face SK lesions
- Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
- Willing to have three of the designated SK lesions treated in a single treatment session
- Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
Show all 11Show fewer
- Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
- No subject identity will be possible via the "lesion-only" photograph
- No evidence of active infection in the designated tissue prior to treatment
- Is not allergic to Lidocaine or Lidocaine-like products
- Not pregnant or lactating
Who cannot join
- Has an implantable electronic device (e.g., automatic defibrillator)
- Active infection or history of infection within 90 previous days in designated test area
- Not willing or able to sign the Informed Consent
- Non-English speaking or reading
- Is known to be immune-compromised
- Known to be a keloid producer
- On blood thinning medications
- Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Laser & Dermatologic Surgery Center
Chesterfield, Missouri, 63017
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
Premier Plastic Surgery
San Mateo, California, 94401
About this study
Official title: Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
Read the detailed description
Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
The specific objectives of this study are to:
- Document the non-treated appearance of off-face SKs.
- Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion.
- Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.
- Conditions
- Lesion Skin, Seborrheic Keratosis
- Being tested
- Nano-Pulse Stimulation (NPS)
- Keywords
- Nano-Pulse Stimulation, Seborrheic Keratosis
- 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
The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.
| Study group | Role | What they receive |
|---|---|---|
| Nano-Pulse Stimulation (NPS) Lesion | Active comparator | Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. Receives: Device: Nano-Pulse Stimulation (NPS) |
| Non-Treated Lesion | No intervention | One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of SK Lesions
Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.
Measured: 106-day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start4 May 2017
- Primary completion13 Nov 2017
- Study completion22 May 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 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 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
- NCT03846531
- Sponsor's protocol ID
- NP-SK-002
- Status last verified
- Jul 2023
- First submitted
- 17 Feb 2019
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hruza GJ, Zelickson BD, Selim MM, Rohrer TE, Newman J, Park H, Jauregui L, Nuccitelli R, Knape WA, Ebbers E, Uecker D. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses. Dermatol Surg. 2020 Sep;46(9):1183-1189. doi: 10.1097/DSS.0000000000002278.
PubMed 31809349
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT03846531
- Acronym / sponsor ID
- NP-SK-002
- Conditions
- Lesion Skin, Seborrheic Keratosis
- Keywords
- Nano-Pulse Stimulation, Seborrheic Keratosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 May 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 22 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
Detailed description
Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
The specific objectives of this study are to:
- Document the non-treated appearance of off-face SKs.
- Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion.
- Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
| Arm | Type | Receives |
|---|---|---|
| Nano-Pulse Stimulation (NPS) Lesion | Active comparator | Device: Nano-Pulse Stimulation (NPS)Three of four selected SK lesions receive Nano-Pulse Stimulation treatment. |
| Non-Treated Lesion | No intervention | –One of four SK lesions is randomized to not receiving Nano-Pulse Stimulation treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing to sign the informed consent
- Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
- Medically determined candidate for at least 4 off-face SK lesions
- Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
- Willing to have three of the designated SK lesions treated in a single treatment session
Key exclusion criteria (8 listed)
- Has an implantable electronic device (e.g., automatic defibrillator)
- Active infection or history of infection within 90 previous days in designated test area
- Not willing or able to sign the Informed Consent
- Non-English speaking or reading
- Is known to be immune-compromised
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)The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles. | Device | Nano-Pulse Stimulation (NPS) Lesion |
Primary outcome
Clearance of SK Lesions
Time frame: 106-day post-treatment
Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31809349Hruza GJ, Zelickson BD, Selim MM, Rohrer TE, Newman J, Park H, Jauregui L, Nuccitelli R, Knape WA, Ebbers E, Uecker D. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses. Dermatol Surg. 2020 Sep;46(9):1183-1189. doi: 10.1097/DSS.0000000000002278.
- 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.
4 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 4 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 8 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 22 Aug 2023). 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?
Clearance of SK Lesions (time frame: 106-day post-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 NCT03846531, 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 22 Aug 2023.