CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

Completed · Not applicable

Conditions studied: Warts, Warts Hand, Verruca

In brief

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.

Key facts

Study ID: NCT04738734
Run by: Pulse Biosciences, Inc.
People needed: 150
Starts: 2021-02-16
Expected to finish: 2022-09-25
Last updated by the study team: 2023-11-24

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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