A Phase 4 interventional study of Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) and Cryotherapy in Verruca Vulgaris and Molluscum Contagiosum Skin Infection, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 4 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
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.
184 studies on the registry are indexed under Warts; 29 are open to participants now.
This study's enrollment of 17 is below the median of 70 across 163 interventional studies indexed under Warts.
Browse Warts studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
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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.
Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
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.
Device: Cryotherapy
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Drug: Canthardin Collodion
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.
Also known as: Non-thermal atmospheric pressure plasma (NTAP)
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.
Also known as: Cold Therapy, Liquid Nitrogen
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.
Also known as: Cantharidin
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Numbers of Lesions With Complete Response
Targeted lesion is no longer grossly visible.
Time frame: 12 weeks
Post-Treatment 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. Participants were asked about these symptoms at a 1-week post-first treatment phone call, and then at every in-person follow up visit. Outcome data represents the number of total lesions in each treatment group in which a participant reported at least one of the above adverse symptoms. Results of specific AEs are detailed in the Adverse Event section.
Time frame: 12 weeks
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.
Time frame: 12 weeks
| Milestone | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin |
|---|---|---|---|---|
| Started | 2 | 1 | 11 | 3 |
| Cap | 2 | 0 | 11 | 3 |
| Cryotherapy | 0 | 1 | 11 | 0 |
| Cantharidin | 0 | 0 | 0 | 3 |
| Completed | 2 | 1 | 11 | 1 |
| Not completed | 0 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 |
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.
| lesions | Lesions Treated With Cold Atmospheric Plasma (CAP) | Lesions Treated With Standard of Care (SOC) |
|---|---|---|
| Numbers of Lesions With no Response | 8 | 9 |
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.
| lesions | Lesions Treated With Cold Atmospheric Plasma (CAP) | Lesions Treated With Standard of Care (SOC) |
|---|---|---|
| Numbers of Lesions With Partial Response | 23 | 15 |
Targeted lesion is no longer grossly visible.
| lesions | Lesions Treated With Cold Atmospheric Plasma (CAP) | Lesions Treated With Standard of Care (SOC) |
|---|---|---|
| Numbers of Lesions With Complete Response | 40 | 45 |
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. Participants were asked about these symptoms at a 1-week post-first treatment phone call, and then at every in-person follow up visit. Outcome data represents the number of total lesions in each treatment group in which a participant reported at least one of the above adverse symptoms. Results of specific AEs are detailed in the Adverse Event section.
| lesions | Lesions Treated With Cold Atmospheric Plasma (CAP) | Lesions Treated With Standard of Care (SOC) |
|---|---|---|
| Post-Treatment CAP Tolerability Questionnaire | 10 | 42 |
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.
| units from 0-10 on VAS scale | Lesions Treated With Cold Atmospheric Plasma (CAP) | Lesions Treated With Standard of Care (SOC) |
|---|---|---|
| Score of Visual Analogue Scale Associated With Treatment | 2.5 (0 to 10) | 0.9 (0 to 8) |
Collected over 4 months (maximum of 3 months of treatment, then 1 month post-treatment). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cold Atmospheric Plasma (CAP) Only | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Cryotherapy Only | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| CAP and Cryotherapy | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| CAP and Cantharidin | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin |
|---|---|---|---|---|
| Patient-reported AE: RednessSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 1/11 | 3/3 |
| Physician-determined Sequela: HyperpigmentationSkin and subcutaneous tissue disorders | 1/2 | 1/1 | 8/11 | 3/3 |
| Physician-determined Sequela: HypopigmentationSkin and subcutaneous tissue disorders | 0/2 | 1/1 | 6/11 | 2/3 |
| Patient-reported AE: PainSkin and subcutaneous tissue disorders | 1/2 | 0/1 | 3/11 | 0/3 |
| Patient-Reported AE: BlisteringSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 2/11 | 1/3 |
| Patient-Reported AE: ScabbingSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 0/11 | 1/3 |
| Physician-determined Sequela: ErythemaSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 2/11 | 0/3 |
| Physician-determined Sequela: ScarringSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 2/11 | 0/3 |
| Patient-Reported AE: Other Color ChangeSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 1/11 | 0/3 |
| Age, Categorical(Participants) | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin | Total |
|---|---|---|---|---|---|
| <=18 years | 2 | 1 | 11 | 3 | 17 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin | Total |
|---|---|---|---|---|---|
| Mean | 6.5 (5 to 8) | 10 (10 to 10) | 10 (7 to 14) | 7 (4 to 13) | 9.1 (4 to 14) |
| Sex: Female, Male(Participants) | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin | Total |
|---|---|---|---|---|---|
| Female | 1 | 1 | 2 | 2 | 6 |
| Male | 1 | 0 | 9 | 1 | 11 |
| Race (NIH/OMB)(Participants) | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 2 | 1 | 10 | 2 | 15 |
| More than one race | 0 | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Cold Atmospheric Plasma (CAP) Only | Cryotherapy Only | CAP and Cryotherapy | CAP and Cantharidin | Total |
|---|---|---|---|---|---|
| United States | 2 | 1 | 11 | 3 | 17 |
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Plan to share: No
Ran from Dec 2021 to primary completion in Dec 2022, 12 months.
Results were first posted in Apr 2024, 1 year 3 months after primary completion.
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