Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05070754

Collaborator

The Skin Center Dermatology Group (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Verruca Vulgaris Molluscum Contagiosum Skin Infection	Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) Device: Cryotherapy Drug: Canthardin Collodion	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients

Actual Study Start Date :

Dec 2, 2021

Anticipated Primary Completion Date :

Dec 2, 2022

Anticipated Study Completion Date :

Dec 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cold Atmospheric Plasma (CAP) 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) 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. Other Names: Non-thermal atmospheric pressure plasma (NTAP)
Active Comparator: Cryotherapy 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 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. Other Names: Cold Therapy Liquid Nitrogen
Active Comparator: Cantharidin 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 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. Other Names: Cantharidin

Arm

Intervention/Treatment

Experimental: Cold Atmospheric Plasma (CAP)

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)

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.

Other Names:

Non-thermal atmospheric pressure plasma (NTAP)

Active Comparator: Cryotherapy

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

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.

Other Names:

Cold Therapy

Liquid Nitrogen

Active Comparator: Cantharidin

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

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.

Other Names:

Cantharidin

Outcome Measures

Primary Outcome Measures

Numbers of lesions with no response [12 weeks]
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 [12 weeks]
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 [12 weeks]
Targeted lesion is no longer grossly visible.

Secondary Outcome Measures

Average score of standardized CAP Tolerability questionnaire [12 weeks]
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 [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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