NCT00291057终止2 期
Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in cholinesterase level
研究概览
简要总结
In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.
The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.
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
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed active head lice infestation
- •Parent or guardian must be able to apply treatment
排除标准
- •Allergy to pediculicides or hair care products
- •Scalp conditions other than head lice
- •Previous head lice treatment within the past 4 weeks
- •Current antibiotic treatment
研究组 & 干预措施
1
Experimental
MALG
干预措施: MALG (Drug)
结局指标
主要结局
Change in cholinesterase level
时间窗: 1 day
次要结局
- Clinical evidence of cholinesterase inhibition(1 day)
- Local tolerability(1 day)
- Cure of head lice 14 days after last treatment(2 weeks)
研究者
研究点 (1)
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