Cold Atmospheric Plasma Device Extension Study

NCT ID: NCT05937672

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2026-02-01

Brief 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. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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

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.

Intervention Type: DEVICE

Other Intervention Names

Non-thermal atmospheric pressure plasma (NTAP)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Skin Center Dermatology Group

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Lara Wine Lee

Assistant Professor, Dermatology and Dermatologic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Courtney Linkous, BA

Role: CONTACT

linkousc@musc.edu

843-566-2453

Courtney Rowley

Role: CONTACT

rowle@musc.edu

843-792-4349

Facility Contacts

Chelsea Shope, BA

Role: primary

shopec@musc.edu

843-754-9577

Courtney Linkous, BS

Role: backup

linkousc@musc.edu

843-566-2453

Other Identifiers

Pro00127338

Identifier Type: -

Identifier Source: org_study_id