CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

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.

Study Overview

• Status: Completed
• Conditions: Warts; Warts Hand; Verruca
• Intervention / Treatment: Device: CellFX System Device; Device: Cryosurgery Liquid Nitrogen Sprayer

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD
  • California
    • Beverly Hills, California, United States, 90210
      • Moy-Fincher-Chipps Dermatology
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Dermatology and DermSurgery
  • Florida
    • Clearwater, Florida, United States, 34685
      • Palm Harbor Dermatology
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Oak Dermatology
  • New York
    • New York, New York, United States, 10022
      • JUVA Skin & Laser Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Dermatology & Laser Center of Charleston
  • Texas
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research, Inc.
    • Pflugerville, Texas, United States, 78550
      • Austin Institute for Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CellFX Procedure; CellFX device using pre-defined energy protocols	Device: 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.
Active Comparator: 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.	Device: Cryosurgery Liquid Nitrogen Sprayer; Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wart Resolution	Wart resolution will be assessed by three independent observers, blinded to treatment assignment, who will classify the response for each wart as "resolved" or "not resolved" based on photographs.	30 days from the last CellFX or Cryosurgical Procedure

Collaborators and Investigators

• Sponsor: Pulse Biosciences, Inc.
• Investigators: Study Chair: Richard Nuccitelli, PhD, Pulse Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): September 25, 2022

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Clearance; NPS; CellFX; Nano-Pulse Stimulation; Wart Reduction
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: NP-WC-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes