Cold Atmospheric Plasma Device Extension Study

Phase 3

Recruiting

• Conditions: Verruca Vulgaris; Molluscum Contagiosum
• Interventions: Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)

• Registration Number: NCT05937672
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Study Start: 2023-09-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients from 4-21 years old with at least 1 lesion of vercurra or molluscum.
• 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 determined by review of their medical record
• Immunodeficiency determined by review of their medical record.
• Adverse response to prior treatments determined by review of medical record.
• Signs of self-resolution determined by study team members.
• Conditions that lead to excessive scarring determined by study team members.
• Face and genital lesions determined by study team members.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cold Atmospheric Plasma (CAP)	Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)	We are proposing an open-label extension study 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.

Primary Outcome Measures

Name	Time	Method
Number of lesions with no response	Maximum of 12 months	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.
Number of treatments to complete lesion resolution	Maximum of 12 months	Comparing number of treatments necessary for complete response.
Number of lesions with partial response	Maximum of 12 months	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.
Number of lesions with complete response	Maximum of 12 months	Targeted lesion is no longer grossly visible.

Secondary Outcome Measures

Name	Time	Method
Adverse events from CAP tolerability questionnaire	Maximum of 12 months	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 by means of a standardized grading scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe)
Average score of visual analogue scale associated with treatment	Maximum of 12 months	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States