Trial Outcomes & Findings for CellFX System for the Treatment of Cutaneous Non-Genital Warts (NCT NCT04554394)
NCT ID: NCT04554394
Last Updated: 2023-07-27
Results Overview
Percentage of Verrucae with Clearance (91-100% reduction)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
60-days post-last CellFX treatment
Results posted on
2023-07-27
Participant Flow
A total of 62 study subjects were enrolled. A total of 257 warts were studied, including 195 warts assigned to treatment and 62 assigned to control arm.
62 subjects were enrolled. One wart per subject was randomized and pre-assigned as the control.
Unit of analysis: lesions
Participant milestones
| Measure |
CellFX Treated Warts
CellFX device using pre-defined energy protocols
CellFX 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.
|
Non-Treated Controls
Non-treated wart arm, one study wart per enrolled subject.
|
|---|---|---|
|
Overall Study
STARTED
|
62 195
|
62 62
|
|
Overall Study
COMPLETED
|
53 136
|
53 53
|
|
Overall Study
NOT COMPLETED
|
9 59
|
9 9
|
Reasons for withdrawal
| Measure |
CellFX Treated Warts
CellFX device using pre-defined energy protocols
CellFX 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.
|
Non-Treated Controls
Non-treated wart arm, one study wart per enrolled subject.
|
|---|---|---|
|
Overall Study
Clinical Site Closed due to COVID-19 Restrictions
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
CellFX System for the Treatment of Cutaneous Non-Genital Warts
Baseline characteristics by cohort
| Measure |
CellFX Treated Verrucae
n=62 Participants
CellFX device using pre-defined energy protocols
CellFX 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.
|
|---|---|
|
Age, Continuous
|
47.3 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Class I
|
3 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Class II
|
27 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Class III
|
20 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Class IV
|
12 Participants
n=5 Participants
|
|
Verrucae Disposition
Treated
|
195 warts
n=5 Participants
|
|
Verrucae Disposition
Control
|
62 warts
n=5 Participants
|
|
Verrucae Disposition
Not treated
|
10 warts
n=5 Participants
|
|
Wart Subtype
Common
|
195 warts
n=5 Participants
|
|
Wart Subtype
Plantar
|
55 warts
n=5 Participants
|
|
Wart Subtype
Flat
|
17 warts
n=5 Participants
|
|
Anatomic Location
Hand
|
131 warts
n=5 Participants
|
|
Anatomic Location
Foot
|
79 warts
n=5 Participants
|
|
Anatomic Location
Leg
|
23 warts
n=5 Participants
|
|
Anatomic Location
Knee
|
10 warts
n=5 Participants
|
|
Anatomic Location
Ankle
|
6 warts
n=5 Participants
|
|
Anatomic Location
Arm
|
4 warts
n=5 Participants
|
|
Anatomic Location
Elbow
|
3 warts
n=5 Participants
|
|
Anatomic Location
Wrist
|
3 warts
n=5 Participants
|
|
Anatomic Location
Torso
|
2 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Cryotherapy
|
49 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Over the Counter Medical Treatment
|
40 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Laser Treatment
|
10 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Over the Counter and Laser Treatment
|
8 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Electrocautery
|
7 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Cantharone and Cryotherapy
|
4 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Investigational Product
|
2 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Aldara and Cryotherapy
|
1 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Laser Treatment and Cryotherapy
|
1 warts
n=5 Participants
|
|
History of Prior Verrucae Treatment
Yeast Injection
|
1 warts
n=5 Participants
|
PRIMARY outcome
Timeframe: 60-days post-last CellFX treatmentPopulation: Percent of verrucae clearance observed at 60-days post-last treatment. Reduction in verrucae size and/or clearance not assessed in the "Non-treated Control" Arm/Group or similar.
Percentage of Verrucae with Clearance (91-100% reduction)
Outcome measures
| Measure |
Warts Treated With CellFX (Common, Flat, and Plantar)
n=136 common verrucae
CellFX device using pre-defined energy protocols
CellFX 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.
|
|---|---|
|
Percentage of Verrucae Cleared
|
67.6 percentage of verrucae clearance
|
SECONDARY outcome
Timeframe: 60-days post-last CellFX treatmentPopulation: All Treated Verrucae observed at 60-days post-last CellFX treatment
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)
Outcome measures
| Measure |
Warts Treated With CellFX (Common, Flat, and Plantar)
n=133 total treated warts
CellFX device using pre-defined energy protocols
CellFX 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.
|
|---|---|
|
Subject Satisfaction
|
73.7 percentage of participants
|
Adverse Events
CellFX Treated Wart Lesion
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CellFX Treated Wart Lesion
n=62 participants at risk
CellFX device using pre-defined energy protocols
CellFX 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.
|
|---|---|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
3.2%
2/62 • Number of events 3 • 4 months after initial CellFX Treatment
|
|
General disorders
Pain
|
3.2%
2/62 • Number of events 2 • 4 months after initial CellFX Treatment
|
|
Infections and infestations
Infection
|
4.8%
3/62 • Number of events 3 • 4 months after initial CellFX Treatment
|
|
General disorders
Numbness and swelling
|
1.6%
1/62 • Number of events 1 • 4 months after initial CellFX Treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60