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Device

Cold Plasma for Warts

Phase 3

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum of 12 months

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of cold plasma to treat warts and molluscum lesions in 4-21 year olds over a 4 wk to 1 yr period. Lesion size, pain, and appearance will be monitored.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include changes in lesion size, pain, appearance, and possibly skin irritation from the treatment as observed by dermatologists during the study period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum of 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of lesions with complete response

Number of lesions with no response

Number of lesions with partial response

+1 more

Secondary outcome measures

Adverse events from CAP tolerability questionnaire

Average score of visual analogue scale associated with treatment

Side effects data

From 2022 Phase 4 trial • 17 Patients • NCT05070754

50%

Physician-determined Sequela: Hyperpigmentation

50%

Patient-reported AE: Pain

100%

80%

60%

40%

20%

Study treatment Arm

Cold Atmospheric Plasma (CAP) Only

CAP and Cryotherapy

Cryotherapy Only

CAP and Cantharidin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cold Atmospheric Plasma (CAP)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2021

Completed Phase 4

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,596 Total Patients Enrolled

1 Trials studying Molluscum Contagiosum

17 Patients Enrolled for Molluscum Contagiosum

The Skin Center Dermatology GroupIndustry Sponsor

3 Previous Clinical Trials

127 Total Patients Enrolled

2 Trials studying Molluscum Contagiosum

117 Patients Enrolled for Molluscum Contagiosum

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age restriction for this medical trial extend to those above 55 years?

"Eligibility for this trial is restricted to those between the ages of 4 and 21. There are 12 trials available for minors, while 15 studies can be taken advantage of by seniors."

Answered by AI

Is recruitment still open for this research endeavor?

"This clinical trial is openly accepting participants, as indicated on the information available through ClinicalTrials.gov. The study was posted on September 18th 2023 and last edited October 17th of the same year."

Answered by AI

How many participants have been enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov states that the clinical trial is presently recruiting participants, which was initially announced on September 18th 2023 and revised most recently on October 17th 2023. 40 individuals are required from a single medical centre to take part in this study."

Answered by AI

Has Cold Atmospheric Plasma (CAP) obtained clearance from the FDA?

"Our team at Power has given Cold Atmospheric Plasma (CAP) a rating of 3 on the safety scale due to its Phase 3 trial status, indicating there is ample evidence in support of both efficacy and safety."

Answered by AI

Am I eligible to be part of this research endeavor?

"To be eligible for this study, individuals must have molluscum contagiosum and fall between the ages of 4 and 21. The trial is seeking to recruit 40 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cold Atmospheric Plasma Device Extension Study

Lara Wine Lee 2023. "Cold Atmospheric Plasma Device Extension Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05937672.