Nanopulse Efficacy Study for the Treatment of Common Warts
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|ClinicalTrials.gov Identifier: NCT02650466|
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
The purpose of this study is to determine if the Nanopulse System can be used to clear common wart lesions on the skin. The Nanopulse System uses a series of low energy, high voltage pulses, each one several billionths of a second in duration, to effectively kill the target tissue contained within the applicator tip electrodes with minimal damage to surrounding tissue. Efficacy and patient outcomes are expected to equal or surpass current treatment modalities in terms of increased ease of use, faster patient healing and minimal scarring with fewer complications resulting from treatment.
The device emits significantly less energy than existing electro-surgery or electro-cautery equipment and is believed to be similar to laser therapy treatment of warts. Trained clinicians can usually diagnose warts based by their appearance and location . Non-genital warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any immune deficiencies are low risk and are the focus of this study.Based upon the preclinical profile of the Nanopulse device, particularly its safety profile and its effect on transformed cells, it is hypothesized that application of pulses from the Nanopulse System , will result in complete clinical clearance of Common Wart lesions with minimal scarring.
|Condition or disease||Intervention/treatment||Phase|
|Common Warts||Device: Nanopulse System||Not Applicable|
Study Objective: The objective of this study is to indicate whether the Nanopulse System is efficacious for use in clearing common warts.
The primary objective of this study is to gather lesion clearance data on common warts after application of pulses from the Nanopulse System and determine the optimal number of treatments necessary. Clearance will be measured by clinical observation.
Other objectives of the study include gathering efficacy data on the use of the Nanopulse System for treating common warts in terms of:
1.) Safety in a clinical setting in terms of minimal adverse events over the course of the trial; 2.) Cosmetic results during the healing process and cosmetic outcome; 3.)Effects of 1, 2, 3 or 4 treatments in terms of clearance and cosmetic outcome for each treated wart; 4.)Subject impressions immediately following application of pulses; 5.)Subject satisfaction with the treatment and cosmetic outcome during and following the healing process; 6) Device performance and clinical feedback under actual clinical conditions and to gather information on design features that may be modified to optimize the device.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nanopulse Efficacy Study for the Treatment of Common Warts|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 20, 2016|
|Actual Study Completion Date :||September 26, 2016|
Experimental: 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 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. The minimum number of treatments per wart is one and the maximum is 4. They will return at the 12 week point post last visit for final assessment and evaluation.
Device: Nanopulse System
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 detachable applicator tip delivers the pulses to the skin through five 3 mm long needle electrodes (27 gauge). The applied electric field, is limited to the space enclosed by the 4 outer electrodes in the applicator tip. An inert, water based gel is applied to the skin and the applicator tip before making contact between subject and applicator tip to ensure that there are no air gaps present between the electrodes through which electrical arcing could occur while pulses are being delivered to the subject. 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.
- Clinical Clearance of Warts [ Time Frame: 168 days after first treatment application ]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.
- Total Number of Adverse Events That Occur During the Course of the Study [ Time Frame: an average of 140 days ]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.
- Total Number of Serious Adverse Events That Occur During the Course of the Study [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650466
|United States, California|
|Huntington Medical Foundation|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Stefani Takahashi, MD||University of Southern California|