Verruca VulgarisPhase 3NCT05937672
Cold Atmospheric Plasma Device Extension Study
A Phase 3 study testing Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) in people with Verruca Vulgaris and Molluscum Contagiosum, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Verruca Vulgaris, Molluscum Contagiosum
- What is being tested?
- Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 19 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients from 4-21 years old with at least 1 lesion of vercurra or molluscum.
- Willingness of the participant and their guardian to provide consent when applicable.
Who cannot join
- Unwillingness to participate in the study
- Received any treatment on the lesion in the past month determined by review of their medical record
- Immunodeficiency determined by review of their medical record.
- Adverse response to prior treatments determined by review of medical record.
- Signs of self-resolution determined by study team members.
- Conditions that lead to excessive scarring determined by study team members.
- Face and genital lesions determined by study team members.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study
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.
- Conditions
- Verruca Vulgaris, Molluscum Contagiosum
- Being tested
- Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
- Keywords
- Plasma, Warts, Molluscum, Pediatric, Dermatology
- Medical subject headings
- Warts, Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)Device
Also called Non-thermal atmospheric pressure plasma (NTAP)
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Atmospheric Plasma (CAP) | Experimental | 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. Receives: Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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.
Measured: Maximum of 12 months
Number 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.
Measured: Maximum of 12 months
Number of lesions with complete response
Targeted lesion is no longer grossly visible.
Measured: Maximum of 12 months
Number of treatments to complete lesion resolution
Comparing number of treatments necessary for complete response.
Measured: Maximum of 12 months
Secondary outcomes (2)
Adverse events from 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 by means of a standardized grading scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe)
Measured: Maximum of 12 months
Average 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.
Measured: Maximum of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start18 Sep 2023
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Why it stopped: Device needed repairs and delay this would cause would have affected data integrity if study were continued due to treatment delay.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verruca VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an open-label extension study. During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure. All lesions selected will be treated with non-thermal atmospheric plasma (NTAP).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- The Skin Center Dermatology Group
- Responsible party
- Principal investigator, Lara Wine Lee, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937672
- Sponsor's protocol ID
- Pro00127338
- Status last verified
- Jan 2025
- First submitted
- 30 Jun 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study
- ClinicalTrials.gov ID
- NCT05937672
- Acronym / sponsor ID
- Pro00127338
- Conditions
- Verruca Vulgaris, Molluscum Contagiosum
- Keywords
- Plasma, Warts, Molluscum, Pediatric, Dermatology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device needed repairs and delay this would cause would have affected data integrity if study were continued due to treatment delay.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- The Skin Center Dermatology Group
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label extension study. During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure. All lesions selected will be treated with non-thermal atmospheric plasma (NTAP).
| Arm | Type | Receives |
|---|---|---|
| Cold Atmospheric Plasma (CAP) | Experimental | Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)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. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All patients from 4-21 years old with at least 1 lesion of vercurra or molluscum.
- Willingness of the participant and their guardian to provide consent when applicable.
Key exclusion criteria (7 listed)
- Unwillingness to participate in the study
- Received any treatment on the lesion in the past month determined by review of their medical record
- Immunodeficiency determined by review of their medical record.
- Adverse response to prior treatments determined by review of medical record.
- Signs of self-resolution determined by study team members.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)Also: Non-thermal atmospheric pressure plasma (NTAP)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. | Device | Cold Atmospheric Plasma (CAP) |
Primary outcome
Number of lesions with no response
Time frame: Maximum of 12 months
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.
Number of lesions with partial response
Time frame: Maximum of 12 months
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.
Number of lesions with complete response
Time frame: Maximum of 12 months
Targeted lesion is no longer grossly visible.
Number of treatments to complete lesion resolution
Time frame: Maximum of 12 months
Comparing number of treatments necessary for complete response.
2 secondary outcomes
Adverse events from CAP tolerability questionnaire
Time frame: Maximum of 12 months
Average score of visual analogue scale associated with treatment
Time frame: Maximum of 12 months
Results and safety
The study was stopped early (reason given: Device needed repairs and delay this would cause would have affected data integrity if study were continued due to treatment delay.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) in people with Verruca Vulgaris and Molluscum Contagiosum, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Device needed repairs and delay this would cause would have affected data integrity if study were continued due to treatment delay.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lesions with no response (time frame: Maximum of 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.