Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

NCT05070754 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 106689
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Verruca Vulgaris; Molluscum Contagiosum Skin Infection

Keywords

Plasma; Cryotherapy; Pediatrics; Warts; Molluscum; Dermatology; Cantharidin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Post-Treatment CAP Tolerability Questionnaire

  12 weeks

• Score of Visual Analogue Scale Associated With Treatment

  12 weeks

Study Arms (3)

Cold Atmospheric Plasma (CAP)

EXPERIMENTAL

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)

Cryotherapy

ACTIVE COMPARATOR

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

Cantharidin

ACTIVE COMPARATOR

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

Interventions

Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) DEVICE

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.

Also known as: Non-thermal atmospheric pressure plasma (NTAP)

Cold Atmospheric Plasma (CAP)

Cryotherapy DEVICE

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.

Also known as: Cold Therapy, Liquid Nitrogen

Cryotherapy

Canthardin Collodion DRUG

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.

Also known as: Cantharidin

Cantharidin

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• The Skin Center Dermatology Group: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Warts

Interventions

Cryotherapy; Cantharidin

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations: * Study was adequately powered with the number of lesions, but a small number of patients enrolled * Low enrollment of patients with skin of color * Patients limited to only three treatments with the NTAP device * Assessment of sustained treatment response was limited to 4 weeks after treatment \& may not represent long-term response * Post-treatment sequelae were measured at the end of the study period. We are unable to determine whether they persisted or self-resolved.

Results Point of Contact

• Title: Dr. Lara Wine Lee
• Organization: Medical University of South Carolina

winelee@musc.edu

(843) 792-3021

Study Officials

• Lara Wine Lee, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dermatology and Dermatologic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: December 2, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)