A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered for the Treatment of Head Lice Infestation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
研究概览
简要总结
The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.
详细描述
This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at the study site. This study used an ex vivo method of assessment for ovicidal efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female based on medical history
- •Six months of age or older.
- •Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
- •Agrees to an examination for head lice and compliance with the study procedures.
- •All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.
排除标准
- •Has scalp disease or a history of allergies or prior reactions to any head lice products.
- •Has a condition that, in the opinion of the Investigator, may interfere with the study.
- •Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
- •Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day
- •Has received an investigational agent within 30 days prior to Day 0.
研究组 & 干预措施
Abametapir Lotion 0.74% w/w
Topically administered to hair and scalp for 10 minutes application.
干预措施: Abametapir Lotion 0.74% w/w (Drug)
Vehicle Lotion
Administered to scalp and hair for 10 minutes application.
干预措施: Vehicle Lotion (Drug)
结局指标
主要结局
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
时间窗: 14 days
Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent.
次要结局
未报告次要终点