NCT05937672

Cold Atmospheric Plasma Device Extension Study

Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 4 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Verruca Vulgaris
• Molluscum Contagiosum

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-18
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2023-07-10
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study