Trial Outcomes & Findings for Nanopulse Efficacy Study for the Treatment of Common Warts (NCT NCT02650466)

Last Updated: 2019-08-06

Results Overview

Response rate is defined in each case in terms of no effect (NE=2), partial response (PR=1), or complete response (CR=0). No Effect (NE) would indicate no clinically apparent reduction in lesion size, Partial Response (PR) would indicate a reduction in lesion size, and Complete Response (CR) would indicate no evidence of the lesion detected.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

168 days after first treatment application

Results posted on

2019-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Nanopulse Treatment The study will be a single center, open label, non-randomized clinical trial that will provide efficacy data for the treatment of common warts by the Nanopulse system in terms of efficacy and cosmetic outcome with 1 - 4 application (treatment) sessions. All subjects will receive a minimum number of applications (n=1 application) per discrete skin wart lesion. Up to 4 warts per subject will be treated with the Nanopulse device. The wart will be debulked to the point of pinpoint bleeding prior to the initial application. The subject will return after 1 week for an evaluation visit and at 4 weeks for a second treatment and 2 additional monthly treatments if warranted. If the subject is declared clinically clear at any of the application visits, they will be placed into follow up. They will return at the 12 week point post last visit for final assessment and evaluation. Nanopulse System: The Nanopulse System consists of an electrical
Overall Study STARTED	24
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Nanopulse Treatment The study will be a single center, open label, non-randomized clinical trial that will provide efficacy data for the treatment of common warts by the Nanopulse system in terms of efficacy and cosmetic outcome with 1 - 4 application (treatment) sessions. All subjects will receive a minimum number of applications (n=1 application) per discrete skin wart lesion. Up to 4 warts per subject will be treated with the Nanopulse device. The wart will be debulked to the point of pinpoint bleeding prior to the initial application. The subject will return after 1 week for an evaluation visit and at 4 weeks for a second treatment and 2 additional monthly treatments if warranted. If the subject is declared clinically clear at any of the application visits, they will be placed into follow up. They will return at the 12 week point post last visit for final assessment and evaluation. Nanopulse System: The Nanopulse System consists of an electrical
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	1

Baseline Characteristics

Nanopulse Efficacy Study for the Treatment of Common Warts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nanopulse Treatment n=30 number of warts treated The Nanopulse System consists of an electrical pulse generator, a handpiece, and a detachable applicator tip at the end of the handpiece that interfaces with the treatment area on the skin. The applicator tip delivers pulses to the skin through needle electrodes. The Applicator Tips are designed for single patient use, and are sterilized prior to first use and between treatment sessions using a standard steam autoclave. All subjects will receive a minimum number of applications per discrete skin wart lesion (n=1 application). Up to 4 warts per subject will be treated. The wart will be debulked prior to the initial application. The subject will return after 1 week for an evaluation visit, at 4 weeks for a second treatment and up to 2 additional monthly treatments. Subjects will be evaluated at each application visit and placed in follow-up when they are declared clinically clear. They will return at the 12 week point post last visit for final assessment and evaluation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian (non-Hispanic)	13 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Latino	2 Participants n=5 Participants
Race/Ethnicity, Customized African-American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian/SE Islan	7 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 168 days after first treatment application

Population: The total number of participants who completed the study equals 17. But because one participant had 3 warts that received treated with differing results, they are counted twice (for that participant, one wart cleared and two showed no effect).

Outcome measures

Outcome measures
Measure	Partially Removed(1) n=19 # of warts treated wart size has been reduced in height and width during treatment.
Clinical Clearance of Warts No Effect	2 # of warts
Clinical Clearance of Warts Cleared	13 # of warts
Clinical Clearance of Warts Partially Removed	4 # of warts

SECONDARY outcome

Timeframe: an average of 140 days

Population: During initial treatment of a wart on a digit, mild pain radiated up the finger from the wart at time of treatment. The pain persisted for 30min. P.O. Tylenol was provided at the time treatment. This did not re-occur during treatments 2,3 and 4.

Number of participants who experience an adverse event, regardless of whether they completed the study, will be aggregated through study completion. Both anticipated and unanticipated adverse events will be reported.

Outcome measures

Outcome measures
Measure	Partially Removed(1) n=30 # of warts treated wart size has been reduced in height and width during treatment.
Total Number of Adverse Events That Occur During the Course of the Study	1 participants

SECONDARY outcome

Timeframe: an average of 140 days

Number of participants, regardless of whether they completed the study, who experience serious adverse events will be aggregated through study completion from the clinical report forms and reported at the end of the study.

Outcome measures

Outcome measures
Measure	Partially Removed(1) n=24 Participants wart size has been reduced in height and width during treatment.
Total Number of Serious Adverse Events That Occur During the Course of the Study	0 Participants

Adverse Events

Nanopulse Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nanopulse Treatment n=24 participants at risk
Skin and subcutaneous tissue disorders Local Sensory Abnormality	4.2% 1/24 • Number of events 1 • Adverse Event data (including serious adverse event data) from 24 participants was collected on average for: 209 days (Range: 168-300 days) for the 17 participants who completed the study; and, 79 days (Range:0-217 days) from the 7 participants who did not complete the study. For each adverse event, the details of and circumstances will be recorded at the site and evaluated by the investigator in terms of relatedness, seriousness and the degree to which the event was anticipated.The adverse event will be reported to the sponsor and the Institutional Review Board; and will be followed by study personnel through to its resolution. All unanticipated adverse reactions, regardless of their severity, will be recorded as adverse events and reported to the sponsor.

Additional Information

Cesar E. Blanco,PhD; Sr Director R&D

Alfred E. Mann Insitute at the University of Southern California

Phone: 2138211619

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place