Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

Phase 4

Completed

Interventions: Device: Cryotherapy
Drug: Canthardin Collodion
Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)

Brief Summary: This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions.

Recruitment & Eligibility

Inclusion Criteria

All patients from 4-21 years old with at least 1 lesion of either verruca vulgaris or molluscum contagiosum
Willingness of the participant and their guardian to provide consent when applicable

Exclusion Criteria

Unwillingness to participate in the study
Received any treatment on the lesion in the past month, as determined by review of participant medical record
Immunodeficiency as determined by review of participant medical record
Adverse response to prior treatments as determined by review of medical record
Signs of self-resolution as determined by study team members
Conditions that lead to excessive scarring as determined by study team members
Facial and genital lesions as determined by study team members

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	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.
Cantharidin	Canthardin Collodion	SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Cold Atmospheric Plasma (CAP)	Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)	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.

Primary Outcome Measures

Name	Time	Method
Numbers of Lesions With Complete Response	12 weeks	Targeted lesion is no longer grossly visible.
Numbers of Lesions With no Response	12 weeks	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.
Numbers of Lesions With Partial Response	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Post-Treatment CAP Tolerability Questionnaire	12 weeks	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.
Score of Visual Analogue Scale Associated With Treatment	12 weeks	The visual analogue scale (VAS) is a validated subjective measurement of pain experienced by the patient. It consists of visual-numeric scale, numbered from 0-10. (0) indicate absence of pain or "no pain at all", while (10) indicates severe pain or "worst imaginable pain". This is supplemented by six faces with different expressions, ranging from happy to extremely upset. Each facial expression is assigned a numerical scale from 0 to 10.