This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.
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. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
Investigate MD, LLC
Scottsdale, Arizona, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States
Percentage of Verrucae Cleared
Percentage of Verrucae with Clearance (91-100% reduction)
Time frame: 60-days post-last CellFX treatment
Subject Satisfaction
Satisfaction with reduction in verrucae size or clearance of verrucae measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied)
Time frame: 60-days post-last CellFX treatment
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Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States