Phase 4
N=17
Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Verruca Vulgaris · Molluscum Contagiosum Skin Infection
Bottom Line
View on ClinicalTrials.gov: NCT05070754 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Numbers of Lesions With no Response — 8; 9 lesions — p=0.534
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) (Device); Cryotherapy (Device); Canthardin Collodion (Drug)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Lesions With no Response |
8; 9 | 0.534 |
| PRIMARY Numbers of Lesions With Partial Response |
23; 15 | 0.534 |
| PRIMARY Numbers of Lesions With Complete Response |
40; 45 | 0.534 |
| SECONDARY Post-Treatment CAP Tolerability Questionnaire |
10; 42 | <0.001 sig |
| SECONDARY Score of Visual Analogue Scale Associated With Treatment |
2.5; 0.9 | 0.142 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05070754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.