WartsNCT04738734
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
A study testing CellFX System Device and Cryosurgery Liquid Nitrogen Sprayer in people with Warts and Warts Hand, run by Pulse Biosciences, Inc. at 10 sites in United States.
Trial summary
This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Warts, Warts Hand, Verruca
- What is being tested?
- CellFX System Device and Cryosurgery Liquid Nitrogen Sprayer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Feb 2021to 25 Sep 2022
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 21 and not older than 80 years of age
- Subject has a Fitzpatrick Skin Type I, II, III or IV.
- Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subject must comply with study procedures including all follow-up visits.
- Subject is willing to have warts treated in a single treatment session and understands that their warts may undergo multiple treatment sessions at subsequent visits.
- Subject must have a minimum of 2 warts and up to 8 warts to be treated.
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- Subject with a clinical diagnosis of common warts located on hands and fingers or other body areas that are not located on the scalp, nose, within the orbital region of the face, plantar, genital or periungual area.
- For study purposes, the warts must be no greater than 3 mm in height and must not exceed 10mm x 10mm at their largest dimension.
- Each wart must appear alone and discrete and not appear in clusters.
- Each wart must have been present for at least 4 weeks.
- Subject consents to have photographs taken of the warts.
- Subject agrees to refrain from using all other wart removal products or treatments (e.g.
- topical medication including over-the-counter medications) during the study period.
Who cannot join
- Subject with more than 8 visible warts in total anywhere on the body.
- Subject has flat, periungual, subungual, genital, anal, mosaic, plantar or filiform warts.
- Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
- Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
- Subject is taking antihistamines, including those used for gastric symptoms.
- Subject is prone to Koebnerization or has any of the following conditions (e.g., psoriasis, vitiligo, lichen planus, or an autoimmune disorder of the skin)
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- Subject is not willing or able to sign the Informed Consent.
- Subject is known to be immune compromised.
- Subject has allergies to Lidocaine or Lidocaine-like products.
- Subject is a member of a vulnerable population including individuals 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.
- Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
- Subject was previously treated with CellFX for warts.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Moy-Fincher-Chipps Dermatology
Beverly Hills, California, 90210
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Palm Harbor Dermatology
Clearwater, Florida, 34685
AboutSkin Dermatology and DermSurgery
Greenwood Village, Colorado, 80111
Austin Institute for Clinical Research, Inc.
Houston, Texas, 77056
Oak Dermatology
Joliet, Illinois, 60435
Juva Skin & Laser Center
New York, New York, 10022
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78550
Investigate MD
Scottsdale, Arizona, 85255
About this study
Official title: A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts
This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.
Read the detailed description
The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.
- Conditions
- Warts, Warts Hand, Verruca
- Being tested
- CellFX System Device, Cryosurgery Liquid Nitrogen Sprayer
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance, Wart Reduction
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX System DeviceDevice
The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
Cryosurgery Liquid Nitrogen SprayerDevice
Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
| Study group | Role | What they receive |
|---|---|---|
| CellFX Procedure | Experimental | CellFX device using pre-defined energy protocols Receives: Device: CellFX System Device |
| Cryosurgical Procedure | Active comparator | Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer. Receives: Device: Cryosurgery Liquid Nitrogen Sprayer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Warts Resolved
The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.
Measured: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Percentage of Warts Treated With Skin Textural Changes
The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.
Measured: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Presence of Pigmentary and Scarring Skin Changes
The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.
Measured: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start16 Feb 2021
- Primary completion15 Dec 2021
- Study completion25 Sep 2022
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.
- Other trials for WartsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 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
- NCT04738734
- Sponsor's protocol ID
- NP-WC-015
- Status last verified
- Nov 2023
- First submitted
- 31 Jan 2021
- Last updated
- 24 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts
- ClinicalTrials.gov ID
- NCT04738734
- Acronym / sponsor ID
- NP-WC-015
- Conditions
- Warts, Warts Hand, Verruca
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance, Wart Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.
Detailed description
The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CellFX Procedure | Experimental | Device: CellFX System DeviceCellFX device using pre-defined energy protocols |
| Cryosurgical Procedure | Active comparator | Device: Cryosurgery Liquid Nitrogen SprayerCryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must be at least 21 and not older than 80 years of age
- Subject has a Fitzpatrick Skin Type I, II, III or IV.
- Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subject must comply with study procedures including all follow-up visits.
- Subject is willing to have warts treated in a single treatment session and understands that their warts may undergo multiple treatment sessions at subsequent visits.
Key exclusion criteria (14 listed)
- Subject with more than 8 visible warts in total anywhere on the body.
- Subject has flat, periungual, subungual, genital, anal, mosaic, plantar or filiform warts.
- Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
- Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
- Subject is taking antihistamines, including those used for gastric symptoms.
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 |
|---|---|---|
| CellFX System DeviceThe CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death. | Device | CellFX Procedure |
| Cryosurgery Liquid Nitrogen SprayerCryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe. | Device | Cryosurgical Procedure |
Primary outcome
Percentage of Warts Resolved
Time frame: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.
Percentage of Warts Treated With Skin Textural Changes
Time frame: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.
Presence of Pigmentary and Scarring Skin Changes
Time frame: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months
The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX System Device and Cryosurgery Liquid Nitrogen Sprayer in people with Warts and Warts Hand, run by Pulse Biosciences, Inc. at 10 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 13 inclusion and 14 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 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 21 Nov 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?
Percentage of Warts Resolved (time frame: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months). The study lists 3 primary outcomes in all. 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 24 Nov 2023.