CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

NCT04738734 | Completed Results FDA Device

• 1 other identifier: NP-WC-015
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 10

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.

Conditions

Warts; Warts Hand; Verruca

Keywords

CellFX; Nano-Pulse Stimulation; NPS; Clearance; Wart Reduction

Outcome Measures

Primary Outcomes (3)

• 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 6 months

Study Arms (2)

CellFX Procedure

EXPERIMENTAL

CellFX device using pre-defined energy protocols

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.

Device: Cryosurgery Liquid Nitrogen Sprayer

Interventions

CellFX System Device 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.

CellFX Procedure

Cryosurgery Liquid Nitrogen Sprayer DEVICE

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

Cryosurgical Procedure

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (10)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Moy-Fincher-Chipps Dermatology

Beverly Hills, California, 90210, United States

Location

AboutSkin Dermatology and DermSurgery

Greenwood Village, Colorado, 80111, United States

Location

Palm Harbor Dermatology

Clearwater, Florida, 34685, United States

Location

Oak Dermatology

Joliet, Illinois, 60435, United States

Location

Juva Skin & Laser Center

New York, New York, 10022, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Dermatology & Laser Center of Charleston

Charleston, South Carolina, 29414, United States

Location

Austin Institute for Clinical Research, Inc.

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78550, United States

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: William A. Knape, VP Clinical, Regulatory, and Quality Affairs
• Organization: Pulse Biosciences, Inc.

bknape@pulsebiosciences.com

510-906-4649

Study Officials

• Richard Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: February 16, 2021
• Primary Completion: December 15, 2021
• Study Completion: September 25, 2022
• Last Updated: November 24, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)