Effect of Cold Atmospheric Plasma on Malassezia Folliculitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 50% reduction in number of lesion
研究概览
简要总结
The cold atmospheric plasma may provide a new and effective method for the treatment of Malassezia folliculitis. The investigators conduct this randomized controlled trial to evaluate the effectiveness and safety of cold atmospheric plasma on Malassezia folliculitis. Participants entered this double-blind placebo-controlled trial will randomly assign to treatment with either cold atmospheric plasma or antifungal drugs. The differences of treatment effects of the two groups will be observed and compared.
详细描述
Malassezia folliculitis is a common disease of young and middle-aged people. It is an inflammatory disease caused by Malassezia infection. Generally, Topical or systemic use of antifungal drugs are the first choice for treatment but sometimes are limited due to adverse drug reactions and drug resistance. Cold atmospheric plasma has an inhibitory or killing effect on pathogenic microorganisms including fungi and has no obvious adverse damage to normal tissues. The investigators conduct this randomized controlled trial to study the effect of cold atmospheric plasma on Malassezia folliculitis, and evaluate its effectiveness and safety for Malassezia folliculitis. All data are recorded and compared after the end of the experiment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are clinical presentation of Malassezia folliculitis in seborrheic areas.
- •The diagnoses are mycologically verified by experienced laboratory technicians.
- •Participants must be informed of the investigational nature of this study and be willing to provide written informed consent.
排除标准
- •Combined with other serious systemic diseases.
- •History of topical corticosteroids within 2 weeks or history of systemic corticosteroids within 1 month.
- •History of immunosuppressive drugs within 1 month.
- •History of topical antifungal medication within 2 weeks or systemic antifungal medication within 3 months.
- •Pregnant and lactating women.
研究组 & 干预措施
cold atmospheric plasma treatment group
Patients are treated with a plasma device. Each treatment time was 3min per area based on the lesion size.The frequency of treatment is once a day. The duration of the treatment period is 2weeks.
干预措施: Cold atmospheric plasma treatment device (Device)
Itraconazole capsules treatment group
Patients are treated with Itraconazole capsules, 200mg a day.The duration of the treatment period is 2weeks.
干预措施: Itraconazole Capsules (Drug)
结局指标
主要结局
50% reduction in number of lesion
时间窗: week 2
proportion of subjects who achieve at least a 50% reduction in total number of lesions
次要结局
- proportion of subjects in physician's global assessment.(week 2)
研究者
Yang chunjun
Head of Dermatology
The Second Hospital of Anhui Medical University