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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Courtney Linkous, BA
linkousc@musc.edu
843-566-2453
Backup
Courtney Rowley
rowle@musc.edu
843-792-4349
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: The Skin Center Dermatology Group

This content was sourced from clinicaltrials.gov

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