Verruca, Warts, Warts Hand
Conditions
Keywords
CellFX, Nano-Pulse Stimulation, NPS, Clearance, Wart Reduction
Brief 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 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.
Interventions
DEVICECellFX System Device
The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
DEVICECryosurgery Liquid Nitrogen Sprayer
Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Each subject will be evaluated by the blinded site investigator conducting assessment of outcomes at 7, 30, 60, and 90-days following CellFX and Cryosurgical treatments.
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Warts Resolved | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CellFX Procedure CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death. | 75 |
| Cryosurgical Procedure Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe. | 75 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Mistake of termination of subject by clinical site | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Cryosurgical Procedure | Total | CellFX Procedure |
|---|---|---|---|
| Age, Continuous | 46.2 Years | 45.4 Years | 44.6 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 17 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 133 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 67 Participants | 137 Participants | 70 Participants |
| Sex: Female, Male Female | 44 Participants | 80 Participants | 36 Participants |
| Sex: Female, Male Male | 31 Participants | 70 Participants | 39 Participants |
| Warts | 248 warts | 479 warts | 231 warts |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 10 / 75 | 2 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
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.
Time frame: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Population: The population consisted of participants with treated warts and evaluated at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CellFX Procedure | Percentage of Warts Resolved | 80.7 percentage of warts resolved |
| Cryosurgical Procedure | Percentage of Warts Resolved | 73.1 percentage of warts resolved |
Primary
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.
Time frame: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Population: The population consisted of participants with treated warts and evaluated for skin textural changes at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CellFX Procedure | Percentage of Warts Treated With Skin Textural Changes | 41.4 percentage of warts |
| Cryosurgical Procedure | Percentage of Warts Treated With Skin Textural Changes | 13.1 percentage of warts |
Primary
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.
Time frame: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months
Population: The population consisted of participants with treated warts and evaluated at 90-days following the last CellFX or Cryosurgical Procedure up to a maximum of 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CellFX Procedure | Presence of Pigmentary and Scarring Skin Changes | 37.3 percentage of lesions |
| Cryosurgical Procedure | Presence of Pigmentary and Scarring Skin Changes | 23.7 percentage of lesions |