We are proposing a clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for the treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to the medical field, and especially to dermatology, there are already a number of publications regarding its use on human skin in adults and children. CAP devices utilize noble gases (such as helium) to deliver plasma state matter to the skin. As its name implies, the generated plasma stream is of near skin temperature and it exists on normal atmospheric pressure. During the generation of the plasma there is no electric contact with the patient. The treatment does not increase skin surface temperature and the used helium gas, the same as used for balloons, being a noble gas does not cause a chemical reaction with the skin. The flow of the gas is slow, thus there is no mechanical effect on the skin.

Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.

SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.

The treatment device in this study generates cold atmospheric plasma. Cold atmospheric plasma has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator supplying 20 kilovolt pulse of 20-ns pulse width at 200 Hz (FPG10-01NM10, FID GmbH, Burbach, Germany) to a 5-mm diameter quartz-covered copper electrode of 10-cm length and 1 - 13mm quartz thickness. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We will treat the lesions for approximately 1 to 2 minutes each, moving the electrode gently over the treatment area.

Absence of change in appearance of targeted lesion. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo.

There is change in the size, dyspigmentation, or discomfort of the targeted lesion as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 4, 8, and 12 weeks, with the final outcome measured at the 12-week visit.

Targeted lesion is no longer grossly visible.

This questionnaire measures tolerability of cold atmospheric plasma treatment. Assessment of dryness, peeling, scaling, erythema, edema, stinging, burning sensation, itching, scarring and dyspigmentation will each be assessed individually. Participants were asked about these symptoms at a 1-week post-first treatment phone call, and then at every in-person follow up visit. Outcome data represents the number of total lesions in each treatment group in which a participant reported at least one of the above adverse symptoms. Results of specific AEs are detailed in the Adverse Event section.

We conducted clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to dermatology, publications exist regarding its use on human skin in adults and children. CAP devices utilize noble gases (such as helium) to deliver plasma state matter to the skin. The generated plasma stream is near skin temperature and exists on normal atmospheric pressure. In generation of plasma, there is no electric contact with the patient. Treatment does not increase skin surface temperature; the used helium gas is a noble gas and does not cause a chemical reaction with the skin. Flow of the gas is slow, thus there is no mechanical effect on skin.

Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP): The treatment device in this study generates CAP. CAP has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator, which supplied 17 kHz, 6 µs width pulse at a power density of approximately 2 W/cm2 (AAPlasma, Philadelphia, PA) was connected to a 10 mm diameter quartz-covered copper electrode of 50 mm length and 1 mm quartz thickness with one end fused. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We treated lesions for 2 minutes each, moving the electrode gently over the treatment area.

Absence of change in appearance of targeted lesion. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo.

The analyzed unit for this outcome is individual lesions. The sum of the number of participants in the two categories being higher than the total number of participants enrolled in the study is a result of the two categories not being mutually exclusive, as participants could have multiple lesions enrolled that were randomized to either CAP or SOC.

We conducted clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to dermatology, publications exist regarding its use on human skin in adults and children. CAP devices utilize noble gases (such as helium) to deliver plasma state matter to the skin. The generated plasma stream is near skin temperature and exists on normal atmospheric pressure. In generation of plasma, there is no electric contact with the patient. Treatment does not increase skin surface temperature; the used helium gas is a noble gas and does not cause a chemical reaction with the skin. Flow of the gas is slow, thus there is no mechanical effect on skin.

Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP): The treatment device in this study generates CAP. CAP has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator, which supplied 17 kHz, 6 µs width pulse at a power density of approximately 2 W/cm2 (AAPlasma, Philadelphia, PA) was connected to a 10 mm diameter quartz-covered copper electrode of 50 mm length and 1 mm quartz thickness with one end fused. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We treated lesions for 2 minutes each, moving the electrode gently over the treatment area.

Patients reporting pain within individual lesions within 1 week of first treatment.