Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients
Overview
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Numbers of Lesions With Complete Response
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) (Device)
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.
Intervention: Cryotherapy (Device)
Cantharidin
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Intervention: Canthardin Collodion (Drug)
Outcomes
Primary Outcomes
Numbers of Lesions With Complete Response
Time Frame: 12 weeks
Targeted lesion is no longer grossly visible.
Numbers of Lesions With no Response
Time Frame: 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
Time Frame: 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 Outcomes
- Post-Treatment CAP Tolerability Questionnaire(12 weeks)
- Score of Visual Analogue Scale Associated With Treatment(12 weeks)
Investigators
Lara Wine Lee
Assistant Professor, Dermatology and Dermatologic Surgery
Medical University of South Carolina