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Device

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

Phase 4
Waitlist Available
Led By Lara Wine Lee, MD, PhD
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 12 weeks
Awards & highlights

Study Summary

This trial is testing a new device that uses cold plasma to treat warts and molluscum. The study will last 4-12 weeks, and will test how well the device works and if it is safe.

Eligible Conditions
  • Plantar Warts
  • Molluscum Contagiosum

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numbers of Lesions With Complete Response
Numbers of Lesions With Partial Response
Numbers of Lesions With no Response
Secondary outcome measures
Post-Treatment CAP Tolerability Questionnaire
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%
0%
Study treatment Arm
Cold Atmospheric Plasma (CAP) Only
CAP and Cryotherapy
Cryotherapy Only
CAP and Cantharidin

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cold Atmospheric Plasma (CAP)Experimental Treatment1 Intervention
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.
Group II: CantharidinActive Control1 Intervention
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Group III: CryotherapyActive Control1 Intervention
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.
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

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,619 Total Patients Enrolled
1 Trials studying Molluscum Contagiosum
40 Patients Enrolled for Molluscum Contagiosum
The Skin Center Dermatology GroupIndustry Sponsor
3 Previous Clinical Trials
150 Total Patients Enrolled
2 Trials studying Molluscum Contagiosum
140 Patients Enrolled for Molluscum Contagiosum
Lara Wine Lee, MD, PhDPrincipal InvestigatorMedical University of South Carolina

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Lara Wine Lee 2021. "Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05070754.
~5 spots leftby Apr 2025
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