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CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
NA trial testing CellFX System Device in Warts in 150 participants. Completed in 25 September 2022.
| Lead sponsor | Pulse Biosciences, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 16 February 2021 |
| Primary completion | 15 December 2021 |
| Estimated completion | 25 September 2022 |
| Sites | 10 locations across United States |
Pulse Biosciences, Inc.
Adults 22 to 80, any sex, with Warts or Warts Hand. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| CellFX Procedure | 80.7 | 71.1 – 90.2 |
| Cryosurgical Procedure | 73.1 | 64.2 – 81.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| CellFX Procedure | 41.4 | 32.5 – 50.3 |
| Cryosurgical Procedure | 13.1 | 5.73 – 20.5 |
The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.
| Group | Value | 95% CI |
|---|---|---|
| CellFX Procedure | 37.3 | 25.5 – 49.0 |
| Cryosurgical Procedure | 23.7 | 14.1 – 33.3 |
Time frame: 150 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CellFX Procedure | Cryosurgical Procedure |
|---|---|---|---|
| Paraesthesia | Skin and subcutaneous tissue disorders | — | — |
| Neuropathy | Skin and subcutaneous tissue disorders | — | — |
| Pain | General disorders | — | — |
| Skin Neoplasm | Skin and subcutaneous tissue disorders | — | — |
| Neoplasm of uncertain behavior of skin | Skin and subcutaneous tissue disorders | — | — |
| Infection | Skin and subcutaneous tissue disorders | — | — |
| Tinea Versicolor | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT04738734 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing