Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 4

Conditions: Molluscum Contagiosum Skin Infection; Verruca Vulgaris

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05070754

106689

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 4 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

Cold Atmospheric Plasma (CAP)

Experimental group

Description:

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.

Treatment:

Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)

Cryotherapy

Active Comparator group

Description:

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.

Treatment:

Device: Cryotherapy

Cantharidin

Active Comparator group

Description:

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

Treatment:

Drug: Canthardin Collodion