Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of lesions with no response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP) (Device)
结局指标
主要结局
Number of lesions with no response
时间窗: 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 treatments to complete lesion resolution
时间窗: Maximum of 12 months
Comparing number of treatments necessary for complete response.
Number of lesions with partial response
时间窗: 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
时间窗: Maximum of 12 months
Targeted lesion is no longer grossly visible.
次要结局
- Average score of visual analogue scale associated with treatment(Maximum of 12 months)
- Adverse events from CAP tolerability questionnaire(Maximum of 12 months)
研究者
Lara Wine Lee
Assistant Professor, Dermatology and Dermatologic Surgery
Medical University of South Carolina