NCT02854878已完成不适用
Treatment of Head Lice Infestation Using Novel Ultrasonic Comb
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Adverse events of the device and treatment
研究概览
简要总结
A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.
23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females
- •Age 6 years and older at the time of enrollment
- •Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
- •Hair must be at least 3 cm long.
- •Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
- •For females of childbearing potential, a statement declaring that she is not currently pregnant.
排除标准
- •Used any chemical head lice treatment in the 7 days preceding the trial treatment
- •Used antibiotics in the week preceding treatment
- •Open wounds in the treatment area
- •Skin irritation in the treatment area
- •Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
- •Known allergies to any of the gel's components
- •Participant that is already enrolled in another study
- •Participant who can't be combed with fine Comb dense ASSY2000
研究组 & 干预措施
treatment
Experimental
干预措施: The Lucy ultrasonic comb models A and B combined with the LucyGel (Device)
结局指标
主要结局
Adverse events of the device and treatment
时间窗: up to three days
measured by AE
次要结局
- Mortality of up to 70% of the mature head lice 3 hours post treatment(3 hours post treatment)
- Mortality of up to 50% of the head lice eggs 14 days post treatment.(14 days post treatment)
研究者
研究点 (1)
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