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NCT Number: NCT05070754

Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

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.

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Key information

Conditions

Verruca Vulgaris DNA Virus Infections Infections Molluscum Contagiosum Skin Infection Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases Warts

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Non-thermal atmospheric pressure plasma (NTAP)

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.

Other names: Cold Therapy, Liquid Nitrogen

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.

Other names: Cantharidin

Primary outcomes

  1. 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.

  2. 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.

  3. Numbers of Lesions With Complete Response

    Time frame: 12 weeks

    Targeted lesion is no longer grossly visible.

Secondary outcomes

  1. Post-Treatment CAP Tolerability Questionnaire

    Time frame: 12 weeks

    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.

  2. Score of Visual Analogue Scale Associated With Treatment

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • The Skin Center Dermatology Group

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2021
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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