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

Trial Summary

What is the purpose of this trial?

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.

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

Research shows that Cold Atmospheric Plasma (CAP) is effective in reducing bacteria and viruses, such as those causing skin infections and herpes, by damaging their cell walls and DNA. This suggests that CAP could potentially be effective in treating warts, which are caused by viruses. ^{1 2 3 4 5}

Is cold plasma treatment safe for humans?

Cold plasma treatment has been tested for safety in humans, showing it is generally well-tolerated with no severe adverse events. Some participants reported moderate pain and temporary skin redness, but these effects were considered acceptable. Studies on human skin and animal models suggest it is safe for short periods, although longer exposure may cause some cellular changes. ^{2 3 5 6 7}

How is the cold plasma treatment for warts different from other treatments?

The cold plasma treatment for warts is unique because it uses ionized gas at room temperature to target the warts, offering antimicrobial and tissue-stimulating effects without causing significant damage to surrounding skin. Unlike traditional treatments, it does not rely on chemicals or heat, making it a novel approach for skin conditions. ^{2 3 5 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

In vitro antimicrobial activity of cold atmospheric microwave plasma against bacteria causing canine skin and ear infections. [2022]

2. England 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Hybrid catalytic-DBD plasma reactor for the production of hydrogen and preferential CO oxidation (CO-PROX) at reduced temperatures. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Nonthermal Dielectric Barrier Discharge (DBD) Plasma Suppresses Herpes Simplex Virus Type 1 (HSV-1) Replication in Corneal Epithelium. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Antibacterial and safety tests of a flexible cold atmospheric plasma device for the stimulation of wound healing. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Inactivation of bacteria by a mixed argon and oxygen micro-plasma as a function of exposure time. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Porcine intact and wounded skin responses to atmospheric nonthermal plasma. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Plasma Medicine: Applications of Cold Atmospheric Pressure Plasma in Dermatology. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Cold plasma treatment is safe for diabetic foot ulcers and decreases Staphylococcus aureus bacterial load. [2023]