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Cold Atmospheric Plasma Device Extension Study

NCT05937672 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Skin Center Dermatology Group

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2025-12-19
Completion
2025-12-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937672 on ClinicalTrials.gov