Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients

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 Overview

• Status: Completed
• Conditions: Verruca Vulgaris; Molluscum Contagiosum Skin Infection
• Intervention / Treatment: Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP); Device: Cryotherapy; Drug: Canthardin Collodion

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP); The treatment device in this study generates cold atmospheric plasma. Cold atmospheric plasma has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator supplying 20 kilovolt pulse of 20-ns pulse width at 200 Hz (FPG10-01NM10, FID GmbH, Burbach, Germany) to a 5-mm diameter quartz-covered copper electrode of 10-cm length and 1 - 13mm quartz thickness. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We will treat the lesions for approximately 1 to 2 minutes each, moving the electrode gently over the treatment area.; Other Names: Non-thermal atmospheric pressure plasma (NTAP)
Active Comparator: 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.	Device: Cryotherapy; Cryotherapy refers to the application of liquid nitrogen using a cryospray device in order to freeze a lesion of interest. Treatment is repeated every few weeks until the lesion of interest has disappeared. It is considered SOC for the treatment of warts.; Other Names: Liquid Nitrogen; Cold Therapy
Active Comparator: 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.	Drug: Canthardin Collodion; Chemical compound that acts as a vesicant to form a blister around treatment area. The blister lifts the lesion of interest away from the skin, causing it to slough off in a few days. It is used as SOC for the treatment of Molluscum Contagiosum.; Other Names: Cantharidin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of Lesions With no Response	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.	12 weeks
Numbers of Lesions With Partial Response	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.	12 weeks
Numbers of Lesions With Complete Response	Targeted lesion is no longer grossly visible.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Treatment CAP Tolerability Questionnaire	This questionnaire measures tolerability of cold atmospheric plasma treatment. Assessment of dryness, peeling, scaling, erythema, edema, stinging, burning sensation, itching, scarring and dyspigmentation will each be assessed individually. Participants were asked about these symptoms at a 1-week post-first treatment phone call, and then at every in-person follow up visit. Outcome data represents the number of total lesions in each treatment group in which a participant reported at least one of the above adverse symptoms. Results of specific AEs are detailed in the Adverse Event section.	12 weeks
Score of Visual Analogue Scale Associated With Treatment	The visual analogue scale (VAS) is a validated subjective measurement of pain experienced by the patient. It consists of visual-numeric scale, numbered from 0-10. (0) indicate absence of pain or "no pain at all", while (10) indicates severe pain or "worst imaginable pain". This is supplemented by six faces with different expressions, ranging from happy to extremely upset. Each facial expression is assigned a numerical scale from 0 to 10.	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: The Skin Center Dermatology Group
• Investigators: Principal Investigator: Lara Wine Lee, MD, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pediatrics; Warts; Plasma; Cryotherapy; Dermatology; Molluscum; Cantharidin
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Virus Diseases; Infections; Inflammation; Connective Tissue Diseases; DNA Virus Infections; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Suppuration; Poxviridae Infections; Cellulitis; Skin Diseases, Infectious; Warts; Molluscum Contagiosum; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cantharidin
• Other Study ID Numbers: 106689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No