Clinical trial NCT05070754: Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Official title: Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Verruca Vulgaris
Molluscum Contagiosum Skin Infection
Keywords: Plasma
Cryotherapy
Pediatrics
Warts
Molluscum
Dermatology
Cantharidin
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: The Skin Center Dermatology Group
First posted: 2021-10-07
Enrollment: 17
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Numbers of Lesions With no Response
timeFrame: 12 weeks
measure: Numbers of Lesions With Partial Response
timeFrame: 12 weeks
measure: Numbers of Lesions With Complete Response
timeFrame: 12 weeks
Secondary outcomes:
measure: Post-Treatment CAP Tolerability Questionnaire
timeFrame: 12 weeks
measure: Score of Visual Analogue Scale Associated With Treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Lara Wine Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: