Cold Plasma for Warts

Overseen By Courtney Rowley

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Medical University of South Carolina

Disqualifiers: Immunodeficiency, Excessive scarring, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks to 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat warts and molluscum lesions using cold plasma. The treatment uses a device called the Floating Electrode-Dielectric Barrier Device (FE-DBD) Cold Atmospheric Plasma (CAP) to deliver non-thermal plasma (a type of ionized gas) to target and treat the lesions. This approach aims to reduce lesion size and pain and improve appearance without heating the skin. The trial is open to patients aged 4 to 21 who have at least one wart or molluscum lesion and have not received treatment for it in the last month. Participants will receive this innovative treatment and be monitored over several months to observe how their lesions respond. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering patients a chance to benefit from cutting-edge therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received any treatment on the lesion in the past month, you may not be eligible to participate.

What prior data suggests that this device is safe for treating warts and molluscum lesions?

Research has shown that cold atmospheric plasma (CAP) treatments, such as the floating electrode-dielectric barrier device (FE-DBD), are generally safe for treating skin conditions like warts and molluscum. Past studies have used CAP on both children and adults without direct skin contact, and it does not increase skin temperature. Helium, the gas used, is safe because it does not react with the skin.

Although CAP is a new approach in medicine, particularly for skin treatments, these studies indicate it is well-tolerated. Participants have reported few, if any, side effects, making CAP a promising option for safely treating skin lesions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about cold atmospheric plasma (CAP) for treating warts because it offers a novel approach without the drawbacks of traditional methods like cryotherapy, salicylic acid, or laser treatment. CAP uses a stream of plasma generated from noble gases, such as helium, to target the warts without direct electric contact and without raising skin temperature. This makes it a painless option with minimal side effects, unlike some current treatments that can cause skin irritation or require lengthy recovery times. Additionally, the lack of a chemical reaction with the skin makes CAP a gentle yet effective alternative.

What evidence suggests that this cold atmospheric plasma device is effective for treating warts?

Research has shown that Cold Atmospheric Plasma (CAP) treatment, which participants in this trial will receive, can help reduce warts and molluscum lesions. In earlier studies, patients who received CAP treatment experienced a noticeable improvement in the size and appearance of their lesions. This treatment uses a special device to apply plasma, a form of matter, to the skin without generating heat. The plasma affects the skin cells, helping to shrink and reduce the number of warts. Overall, CAP has proven to be safe and effective, offering a potential non-invasive option for individuals with these conditions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for young people aged 4-21 with at least one wart or molluscum lesion. They must be willing to consent (with a guardian if needed) and have not treated the lesion in the past month. Those with immunodeficiency, adverse reactions to previous treatments, conditions causing excessive scarring, or lesions resolving on their own are excluded.

Inclusion Criteria

Willingness of the participant and their guardian to provide consent when applicable

I am between 4 and 21 years old and have at least one wart or molluscum.

Exclusion Criteria

You have a condition that causes too much scarring, as determined by the study team.

I have not had any treatments on the lesion in the past month.

My medical records show I had a bad reaction to previous treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-thermal, cold atmospheric plasma to treat all selected lesions. Safety profile and changes in size, pain, and appearance are measured.

4 weeks to 12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Changes in lesion characteristics are evaluated by a dermatologist and documented via photographs.

12 weeks

Follow-up visits at 4, 8, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)

Trial Overview The study tests a cold atmospheric plasma device on warts and molluscum contagiosum. Treatment lasts at least 4 weeks up to monthly sessions for a year based on how quickly lesions clear. The dermatologist will decide which and how many lesions to treat.

How Is the Trial Designed?

Group I: Cold Atmospheric Plasma (CAP) Experimental Treatment 1 Intervention

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.

Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) is already approved in United States for the following indications:

Approved in United States as Floating Electrode-Dielectric Barrier Device (FE-DBD) Cold Atmospheric Plasma (CAP) for:

• Warts
• Molluscum contagiosum

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

The Skin Center Dermatology Group

Industry Sponsor

Trials

5

Recruited

170+

Published Research Related to This Trial

Cold atmospheric microwave plasma (CAMP) effectively kills major bacterial strains responsible for skin infections in dogs, showing complete eradication of Gram-negative bacteria like Pseudomonas aeruginosa and Escherichia coli after 60 seconds of exposure.

CAMP demonstrated similar antibacterial effects against both antibiotic-resistant and antibiotic-susceptible strains of Staphylococcus pseudintermedius, suggesting it could be a valuable alternative treatment for skin infections in dogs where traditional antibiotics fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro antimicrobial activity of cold atmospheric microwave plasma against bacteria causing canine skin and ear infections. Jin, HJ., Hwang, CY., Kang, JH., et al.[2022]

Cold atmospheric plasma (CAP) treatment effectively reduced bacterial counts, achieving a 4 log reduction against Staphylococcus aureus in collagen-elastin matrices and a 2.9 log reduction in Pseudomonas aeruginosa on contaminated skin in 14 out of 15 volunteers.

The treatment was found to be safe for intact skin, with moderate pain reported by participants but no severe adverse events, and it did not negatively impact cellular activity or DNA integrity in human dermal samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial and safety tests of a flexible cold atmospheric plasma device for the stimulation of wound healing. Boekema, B., Stoop, M., Vlig, M., et al.[2022]

The study explores the use of Dielectric Barrier Discharges (DBD) at atmospheric pressure and low temperatures (below 115 degrees C) to effectively decompose methanol and produce hydrogen.

A copper-manganese oxide catalyst is utilized in this process, enhancing the efficiency of hydrogen production and enabling the preferential oxidation of carbon monoxide (CO), which is crucial for improving fuel cell performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid catalytic-DBD plasma reactor for the production of hydrogen and preferential CO oxidation (CO-PROX) at reduced temperatures. Rico, VJ., Hueso, JL., Cotrino, J., et al.[2009]

Cold atmospheric plasma has shown a variety of beneficial effects in biomedicine, including anti-itch, antimicrobial, and anti-inflammatory properties, with no observed resistance from pathogens, making it a promising treatment for skin diseases.

Two types of cold plasma devices, the PlasmaDerm® VU-2010 and the kINPen® MED, are CE-certified for treating chronic wounds and have demonstrated efficacy and good tolerability, with ongoing research into their potential in cancer treatment, particularly in inducing cell death in tumor cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Medicine: Applications of Cold Atmospheric Pressure Plasma in Dermatology. Bernhardt, T., Semmler, ML., Schäfer, M., et al.[2020]

Cold atmospheric plasma (CAP) is safe for use, as it did not increase DNA mutations or cause significant cell damage in V79 fibroblasts and ex vivo burn wound models.

While CAP effectively eliminated bacteria in vitro, it showed limited efficacy in reducing bacterial counts in vivo in rat wound models, indicating that further research is needed to optimize its application for wound infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and bactericidal efficacy of cold atmospheric plasma generated by a flexible surface Dielectric Barrier Discharge device against Pseudomonas aeruginosa in vitro and in vivo. Dijksteel, GS., Ulrich, MMW., Vlig, M., et al.[2021]

Nonthermal plasma, specifically floating electrode-discharge barrier discharge (FE-DBD) plasma, has been shown to be electrically safe for application on living tissues, with a defined exposure threshold of up to 900 seconds at low power and less than 120 seconds at high power in porcine skin studies.

The research indicates that while FE-DBD plasma can promote coagulation and potentially aid in wound healing, prolonged exposure can lead to cellular damage, as evidenced by increased markers for DNA breaks and changes in skin integrity over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porcine intact and wounded skin responses to atmospheric nonthermal plasma. Wu, AS., Kalghatgi, S., Dobrynin, D., et al.[2012]

The study involving 20 patients with diabetic foot ulcers showed that treatment with cold atmospheric plasma (CAP) was safe, with no serious adverse device effects reported and only mild transient effects experienced by 55% of subjects.

CAP treatment significantly reduced the bacterial load of Staphylococcus aureus and led to a 43% decrease in ulcer size, indicating its potential effectiveness in managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cold plasma treatment is safe for diabetic foot ulcers and decreases Staphylococcus aureus bacterial load. Lagrand, RS., Sabelis, LW., de Groot, V., et al.[2023]

The study demonstrated that using a radio-frequency dielectric barrier discharge (DBD) micro-plasma device effectively inactivates Escherichia coli, with optimal results achieved by adding 0.5% oxygen to argon micro-plasma for 30 seconds.

Increasing the exposure time to the micro-plasma was more critical for bacterial inactivation than the concentration of excited oxygen species, indicating that the duration of exposure plays a key role in the effectiveness of this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inactivation of bacteria by a mixed argon and oxygen micro-plasma as a function of exposure time. Weng, CC., Wu, YT., Liao, JD., et al.[2013]

Nonthermal dielectric barrier discharge (DBD) plasma significantly reduces herpes simplex virus type 1 (HSV-1) infection in human corneal epithelial cells and explanted corneas, showing promise as a treatment for herpes keratitis, especially in cases resistant to conventional antivirals.

The treatment with DBD plasma did not cause significant toxicity to the corneas, indicating its potential as a safe alternative therapy for managing herpes keratitis without the side effects associated with traditional antiviral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonthermal Dielectric Barrier Discharge (DBD) Plasma Suppresses Herpes Simplex Virus Type 1 (HSV-1) Replication in Corneal Epithelium. Alekseev, O., Donovan, K., Limonnik, V., et al.[2022]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/54/NCT05070754/Prot_SAP_000.pdf

Using a Cold Atmospheric Plasma Device to Treat ... o We are proposing a clinical trial floating electrode-dielectric barrier device (FE-DBD) a Cold. Atmospheric Plasma (CAP) device. o While ...

2. ctv.veeva.com ctv.veeva.com/study/cold-atmospheric-plasma-device-for-pediatric-molluscum-and-verruca

Cold Atmospheric Plasma Device for Pediatric Molluscum and ... This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05070754/

Trial | NCT05070754 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 ...

4. binasss.sa.cr binasss.sa.cr/ene25/27.pdf

A randomized controlled trial analyzing nonthermal ... Device. This study utilized a floating electrode-dielectric barrier, or cold atmospheric plasma device, loaned to our institution by P.C.F. ...

5. withpower.com withpower.com/trial/phase-3-warts-6-2023-a2619

Cold Plasma for Warts What data supports the effectiveness of the treatment Floating Electrode-Dielectric Barrier Device (FE-DBD) Cold Atmospheric Plasma (CAP) for warts?

6. ctv.veeva.com ctv.veeva.com/study/cold-atmospheric-plasma-device-extension-study

Cold Atmospheric Plasma Device Extension Study We are proposing an open-label extension study of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) ...