Cold Atmospheric Plasma Device Extension Study

Phase 3RecruitingNCT05937672

Medical University of South Carolina40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Verruca Vulgaris Molluscum Contagiosum

Interventions

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number 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.