Cold Atmospheric Plasma Device Extension Study

Molluscum Contagiosum Clinical Trial

Official title:

Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937672
• Other study ID #: Pro00127338
• Status: Recruiting
• Phase: Phase 3
• Start date: September 18, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Medical University of South Carolina
• Contact: Courtney Linkous, BA
• Phone: 843-566-2453
• Email: linkousc[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Molluscum Contagiosum
• Verruca Vulgaris
• Warts

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	The Skin Center Dermatology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Maximum of 12 months
Primary	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.	Maximum of 12 months
Primary	Number of lesions with complete response	Targeted lesion is no longer grossly visible.	Maximum of 12 months
Primary	Number of treatments to complete lesion resolution	Comparing number of treatments necessary for complete response.	Maximum of 12 months
Secondary	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)	Maximum of 12 months
Secondary	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.	Maximum of 12 months