Back to resultsCold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Primary Purpose
Verruca Vulgaris, Molluscum Contagiosum Skin Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
Cryotherapy
Canthardin Collodion
Sponsored by
About this trial
This is an interventional treatment trial for Verruca Vulgaris focused on measuring Plasma, Cryotherapy, Pediatrics, Warts, Molluscum, Dermatology, Cantharidin
Eligibility Criteria
Inclusion Criteria:
- All patients from 4-21 years old with at least 1 lesion of either verruca vulgaris or molluscum contagiosum
- 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, as determined by review of participant medical record
- Immunodeficiency as determined by review of participant medical record
- Adverse response to prior treatments as determined by review of medical record
- Signs of self-resolution as determined by study team members
- Conditions that lead to excessive scarring as determined by study team members
- Facial and genital lesions as determined by study team members
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Cold Atmospheric Plasma (CAP)
Cryotherapy
Cantharidin
Arm Description
We are proposing a clinical trial 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.
Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Outcomes
Primary Outcome Measures
Numbers 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.
Numbers 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.
Numbers of lesions with complete response
Targeted lesion is no longer grossly visible.
Secondary Outcome Measures
Average score of standardized 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
NCT05070754
First Posted
September 27, 2021
Last Updated
May 8, 2023
Sponsor
Medical University of South Carolina
Collaborators
The Skin Center Dermatology Group
1. Study Identification
Unique Protocol Identification Number
NCT05070754
Brief Title
Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Official Title
Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
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
Yes
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
This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Vulgaris, Molluscum Contagiosum Skin Infection
Keywords
Plasma, Cryotherapy, Pediatrics, Warts, Molluscum, Dermatology, Cantharidin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure.The lesions will be marked randomly for a certain treatment regimen. The number of lesions treated will not exceed standard of care (SOC) recommendations. They will be determined by provider assessment and anatomical location. Participants with one lesion will receive either non-thermal atmospheric plasma (NTAP) or SOC. SOC is cryotherapy for warts and cantharidin for molluscum. Participants with greater than 2 lesions will receive equal treatment of NTAP and SOC. The number of lesions treated will be based off the providers assessment and anatomical location. Treatment of a single lesion or an odd number of multiple lesions will be based off a randomized list. All SOC lesions will be treated first to reduce the number of patients not wanting return to the more painful modality.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold Atmospheric Plasma (CAP)
Arm Type
Experimental
Arm Description
We are proposing a clinical trial 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.
Arm Title
Cryotherapy
Arm Type
Active Comparator
Arm Description
Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Arm Title
Cantharidin
Arm Type
Active Comparator
Arm Description
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
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.
Intervention Type
Device
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Cold Therapy, Liquid Nitrogen
Intervention Description
Cryotherapy refers to the application of liquid nitrogen using a cryospray device in order to freeze a lesion of interest. Treatment is repeated every few weeks until the lesion of interest has disappeared. It is considered SOC for the treatment of warts.
Intervention Type
Drug
Intervention Name(s)
Canthardin Collodion
Other Intervention Name(s)
Cantharidin
Intervention Description
Chemical compound that acts as a vesicant to form a blister around treatment area. The blister lifts the lesion of interest away from the skin, causing it to slough off in a few days. It is used as SOC for the treatment of Molluscum Contagiosum.
Primary Outcome Measure Information:
Title
Numbers 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
12 weeks
Title
Numbers 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
12 weeks
Title
Numbers of lesions with complete response
Description
Targeted lesion is no longer grossly visible.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Average score of standardized 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
12 weeks
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
12 weeks
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 either verruca vulgaris or molluscum contagiosum
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, as determined by review of participant medical record
Immunodeficiency as determined by review of participant medical record
Adverse response to prior treatments as determined by review of medical record
Signs of self-resolution as determined by study team members
Conditions that lead to excessive scarring as determined by study team members
Facial and genital lesions as determined by study team members
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Wine Lee, MD, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
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