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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
Investigate MD
Scottsdale, Arizona, United States
Moy-Fincher-Chipps Dermatology
Beverly Hills, California, United States
AboutSkin Dermatology and DermSurgery
Greenwood Village, Colorado, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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