Nanopulse Efficacy Study for the Treatment of Common Warts
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2017 |
| Start Date: | December 2013 |
| End Date: | September 26, 2016 |
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.
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.
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.
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.
Inclusion Criteria:
- Only Common Warts will be included as study lesions.
- Only discrete common warts in a single 5cm x 5cm anatomical area can be included as
study lesions. Up to 4 discrete common warts that meet this criteria can be treated
per subject. The 5cm x 5cm area must not have more than 2 warts present at the time
of screening and warts outside each area must be at least 2cm away from warts
included as study lesions. Please Note: A single digit (e.g. finger) can represent a
5cm x 5cm area, and a lesion within the area can be included as a study lesion UNLESS
it is on the inside surface of a digit where there are wart lesions present on the
surface of an adjacent digit that would be within 1 cm of touching the potential
study lesion when the surfaces of the digits are in contact with one another.
- Subject's lesion may have been treated with over-the-counter treatments, but not by
any prescription medicine, surgery, or destructive procedure (i.e., cryotherapy)
within four weeks of the date the subject is recruited into the study.
- Subject's wart and the subject must be suitable candidates for usual Standard of Care
treatments. Standard of care for common warts is defined as curettage and
electrodesication, cryotherapy, topical therapy or surgery.
- Subject must be competent to provide informed consent.
- If the subject is female, and of childbearing potential, subject must be actively
practicing a clinically acceptable form of birth control.
- Subject's medical evaluation during their screening visit does not indicate any
findings of clinical significance relevant to participating in study.
- Subject has been informed of their options for standard of care for the lesion type
outside of the study.
Exclusion Criteria:
- Subjects not meeting all inclusion criteria should be excluded.
- Subjects who have lesions within the 5cm x 5cm anatomical area under study which are
painful or have been noticeably changing just prior to the time of screening.
- Periungual warts are excluded from the study as study lesions. Subject is to be
informed that these warts will not be treated during the duration of the study.
- Lesions on the face are excluded from the study as study lesions.
- Lesions which are diagnosed as flat warts, filiform warts, plantar warts, and genital
warts are excluded from the study as study lesions. Subject is to be informed that
these warts will not be treated during the duration of the study.
- Subjects who are using or intend to use any other warts therapy concomitantly during
the study period or within 4 weeks of their screening visit.
- Subjects who are not capable of undergoing surgical standard of care treatment for
common warts due to mental or physical limitations.
- Subjects in whom a minor surgical procedure is contraindicated (e.g. under advice of
their own caring clinician).
- Subjects who have an implanted artificial heart valve or other prosthesis requiring
prophylactic antibiotic coverage for minor surgical procedures.
- Subjects who have an implanted cardiac pacer or defibrillator or other similar life
sustaining implanted electrical device.
- Subjects who have had any cosmetic or therapeutic procedure (e.g. use of liquid
nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth
chemical peel, laser resurfacing) within 2cm of targeted area and margins within 4
weeks of the screening visit and within 10cm of treatment area during the study.
- Subjects who are immunosuppressed either due to an existing medical diagnosis, or are
currently using medications that suppress the immune system (e.g. cyclosporine,
prednisone, methotrexate, alefacept, infliximab) or have used these medications
within 8 weeks of the screening visit or anytime during the study.
- Topical immunomodulators (imiquimod, steroid creams) within 4 weeks of the screening
visit or any time during the study.
- Prolonged or excessive exposure to ultra-violet light within 2 weeks prior to
screening visit or any time during the study.
- Subjects who, if female, know that they are currently pregnant or are lactating and
actively breastfeeding.
- Under the Investigator's authority to exclude any participant at his/her discretion,
participation in this study is not recommended for this Subject.
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