CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

NCT ID: NCT04738734

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2022-09-25

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.

Conditions

Warts; Warts Hand; Verruca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CellFX Procedure

CellFX device using pre-defined energy protocols

Group Type: EXPERIMENTAL

CellFX System Device

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Cryosurgery Liquid Nitrogen Sprayer

Intervention Type: DEVICE

Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

Interventions

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.

Intervention Type: DEVICE

Cryosurgery Liquid Nitrogen Sprayer

Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulse Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Nuccitelli, PhD

Role: STUDY_CHAIR

Pulse Biosciences, Inc.

Locations

Investigate MD

Scottsdale, Arizona, United States

Moy-Fincher-Chipps Dermatology

Beverly Hills, California, United States

AboutSkin Dermatology and DermSurgery

Greenwood Village, Colorado, United States

Palm Harbor Dermatology

Clearwater, Florida, United States

Oak Dermatology

Joliet, Illinois, United States

Juva Skin & Laser Center

New York, New York, United States

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Dermatology & Laser Center of Charleston

Charleston, South Carolina, United States

Austin Institute for Clinical Research, Inc.

Houston, Texas, United States

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NP-WC-015

Identifier Type: -

Identifier Source: org_study_id