To hear about similar clinical trials, please enter your email below
Trial Title:
Cold Atmospheric Plasma Device Extension Study
NCT ID:
NCT05937672
Condition:
Verruca Vulgaris
Molluscum Contagiosum
Conditions: Official terms:
Warts
Molluscum Contagiosum
Conditions: Keywords:
Plasma
Warts
Molluscum
Pediatric
Dermatology
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
This is an open-label extension study. During a clinical care visit, if a patient is
eligible and agrees to participate, lesions will be selected by the dermatologist prior
to procedure. All lesions selected will be treated with non-thermal atmospheric plasma
(NTAP).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
Description:
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.
Arm group label:
Cold Atmospheric Plasma (CAP)
Other name:
Non-thermal atmospheric pressure plasma (NTAP)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
4 Years
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chelsea Shope, BA
Phone:
843-754-9577
Email:
shopec@musc.edu
Contact backup:
Last name:
Courtney Linkous, BS
Phone:
843-566-2453
Email:
linkousc@musc.edu
Contact backup:
Last name:
Lara Wine Lee, MD-PhD
Contact backup:
Last name:
Courtney Linkous, BS
Start date:
September 18, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Medical University of South Carolina
Agency class:
Other
Collaborator:
Agency:
The Skin Center Dermatology Group
Agency class:
Industry
Source:
Medical University of South Carolina
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05937672
