Cold Atmospheric Plasma Device Extension Study

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 3

Conditions: Molluscum Contagiosum; Verruca Vulgaris

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05937672

Pro00127338

Details and patient eligibility

About

Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.

Enrollment: 40 estimated 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 vercurra or molluscum.
• 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 determined by review of their medical record
• Immunodeficiency determined by review of their medical record.
• Adverse response to prior treatments determined by review of medical record.
• Signs of self-resolution determined by study team members.
• Conditions that lead to excessive scarring determined by study team members.
• Face and genital lesions determined by study team members.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Cold Atmospheric Plasma (CAP)

Experimental group

Description:

We are proposing an open-label extension study 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)