Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Condition: Verruca Vulgaris; Molluscum Contagiosum Skin Infection
MeSH terms: Cellulitis; Skin Diseases, Infectious; Warts; Molluscum Contagiosum
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP); Cryotherapy; Canthardin Collodion
Intervention type(s): Device; Device; Drug
Intervention description(s): 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.; Cryotherapy refers to the application of liquid nitrogen using a cryospray device in order to freeze a lesion of interest. Treatment is repeated every few weeks until the lesion of interest has disappeared. It is considered SOC for the treatment of warts.; Chemical compound that acts as a vesicant to form a blister around treatment area. The blister lifts the lesion of interest away from the skin, causing it to slough off in a few days. It is used as SOC for the treatment of Molluscum Contagiosum.
Other intervention name(s): Non-thermal atmospheric pressure plasma (NTAP); Cold Therapy; Liquid Nitrogen; Cantharidin
Intervention MeSH terms: Cantharidin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure.The lesions will be marked randomly for a certain treatment regimen. The number of lesions treated will not exceed standard of care (SOC) recommendations. They will be determined by provider assessment and anatomical location. Participants with one lesion will receive either non-thermal atmospheric plasma (NTAP) or SOC. SOC is cryotherapy for warts and cantharidin for molluscum. Participants with greater than 2 lesions will receive equal treatment of NTAP and SOC. The number of lesions treated will be based off the providers assessment and anatomical location. Treatment of a single lesion or an odd number of multiple lesions will be based off a randomized list. All SOC lesions will be treated first to reduce the number of patients not wanting return to the more painful modality.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasma; Cryotherapy; Pediatrics; Warts; Molluscum; Dermatology; Cantharidin