Clinical trial NCT04738734: CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warts
Warts Hand
Verruca
Keywords: CellFX
Nano-Pulse Stimulation
NPS
Clearance
Wart Reduction
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Warts Resolved
timeFrame: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
measure: Percentage of Warts Treated With Skin Textural Changes
timeFrame: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
measure: Presence of Pigmentary and Scarring Skin Changes
timeFrame: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Beverly Hills
country: United States
facility: Moy-Fincher-Chipps Dermatology
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Dermatology and DermSurgery
state: Colorado
city: Clearwater
country: United States
facility: Palm Harbor Dermatology
state: Florida
city: Joliet
country: United States
facility: Oak Dermatology
state: Illinois
city: New York
country: United States
facility: Juva Skin & Laser Center
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston
state: South Carolina
city: Houston
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Richard Nuccitelli, PhD
role: STUDY_CHAIR
References: