A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing
研究概览
简要总结
A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.
详细描述
Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have active head lice infestations (at least 1 live louse and eggs)
- •Good general health based on medical history
- •Each subject has to be consented
排除标准
- •Subjects with any condition that would compromise the study
- •History of irritation or sensitivity to pediculicides or hair care products
- •Subjects with cranial or facial implants
- •Subjects who have received radiation within the last 6 months
- •Subjects with history of heart disease
- •Subjects with history of epilepsy or seizure disorders
- •Subjects with neuro-stimulator or pacemaker
- •Subject with hair that staff cannot comb
- •Subject previously treated in study in last 30 days
- •Use of lice treatment in past 2 weeks
- •Subject unable to sense pain
- •Subject unable to communicate pain
研究组 & 干预措施
Resultz Lice and Egg Elimination Kit
Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour
干预措施: Apply Liquid Then Comb Out (Device)
Placebo Lice and Egg Elimination Kit
20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour
干预措施: Apply Liquid Then Comb Out (Device)
结局指标
主要结局
The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing
时间窗: 1 hour
A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.
次要结局
- Total Number of Lice Removed, Total Number of Eggs Removed(1 hour)