Back to resultsCold Atmospheric Plasma Device Extension Study
Primary Purpose
Verruca Vulgaris, Molluscum Contagiosum
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
Sponsored by
About this trial
This is an interventional treatment trial for Verruca Vulgaris focused on measuring Plasma, Warts, Molluscum, Pediatric, Dermatology
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.
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cold Atmospheric Plasma (CAP)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Number of lesions with partial response
There is change in the size, dyspigmentation, or discomfort of the targeted lesion as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. 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. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 4, 8, and 12 weeks, with the final outcome measured at the 12-week visit.
Number of lesions with complete response
Targeted lesion is no longer grossly visible.
Number of treatments to complete lesion resolution
Comparing number of treatments necessary for complete response.
Secondary Outcome Measures
Adverse events from CAP tolerability questionnaire
This questionnaire measures tolerability of cold atmospheric plasma treatment. Assessment of dryness, peeling, scaling, erythema, edema, stinging, burning sensation, itching, scarring and dyspigmentation will each be assessed individually by means of a standardized grading scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe)
Average score of visual analogue scale associated with treatment
The visual analogue scale (VAS) is a validated subjective measurement of pain experienced by the patient. It consists of visual-numeric scale, numbered from 0-10. (0) indicate absence of pain or "no pain at all", while (10) indicates severe pain or "worst imaginable pain". This is supplemented by six faces with different expressions, ranging from happy to extremely upset. Each facial expression is assigned a numerical scale from 0 to 10.
Full Information
NCT ID
NCT05937672
First Posted
June 30, 2023
Last Updated
October 17, 2023
Sponsor
Medical University of South Carolina
Collaborators
The Skin Center Dermatology Group
1. Study Identification
Unique Protocol Identification Number
NCT05937672
Brief Title
Cold Atmospheric Plasma Device Extension Study
Official Title
Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
The Skin Center Dermatology Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Vulgaris, Molluscum Contagiosum
Keywords
Plasma, Warts, Molluscum, Pediatric, Dermatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold Atmospheric Plasma (CAP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
Other Intervention Name(s)
Non-thermal atmospheric pressure plasma (NTAP)
Intervention 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.
Primary Outcome Measure Information:
Title
Number of lesions with no response
Description
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.
Time Frame
Maximum of 12 months
Title
Number of lesions with partial response
Description
There is change in the size, dyspigmentation, or discomfort of the targeted lesion as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. 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. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 4, 8, and 12 weeks, with the final outcome measured at the 12-week visit.
Time Frame
Maximum of 12 months
Title
Number of lesions with complete response
Description
Targeted lesion is no longer grossly visible.
Time Frame
Maximum of 12 months
Title
Number of treatments to complete lesion resolution
Description
Comparing number of treatments necessary for complete response.
Time Frame
Maximum of 12 months
Secondary Outcome Measure Information:
Title
Adverse events from CAP tolerability questionnaire
Description
This questionnaire measures tolerability of cold atmospheric plasma treatment. Assessment of dryness, peeling, scaling, erythema, edema, stinging, burning sensation, itching, scarring and dyspigmentation will each be assessed individually by means of a standardized grading scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe)
Time Frame
Maximum of 12 months
Title
Average score of visual analogue scale associated with treatment
Description
The visual analogue scale (VAS) is a validated subjective measurement of pain experienced by the patient. It consists of visual-numeric scale, numbered from 0-10. (0) indicate absence of pain or "no pain at all", while (10) indicates severe pain or "worst imaginable pain". This is supplemented by six faces with different expressions, ranging from happy to extremely upset. Each facial expression is assigned a numerical scale from 0 to 10.
Time Frame
Maximum of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Linkous, BA
Phone
843-566-2453
Email
linkousc@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Rowley
Phone
843-792-4349
Email
rowle@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelsea Shope, BA
Phone
843-754-9577
Email
shopec@musc.edu
First Name & Middle Initial & Last Name & Degree
Courtney Linkous, BS
Phone
843-566-2453
Email
linkousc@musc.edu
First Name & Middle Initial & Last Name & Degree
Lara Wine Lee, MD-PhD
First Name & Middle Initial & Last Name & Degree
Courtney Linkous, BS
12. IPD Sharing Statement
Plan to Share IPD
No
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Cold Atmospheric Plasma Device Extension Study
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