NCT00672971已完成不适用
An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100).
研究概览
简要总结
The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.
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
- None
入排标准
- 年龄范围
- 4 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 - 85 years of age
- •active head lice infestation of at least ≥ 10 live lice
- •short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back)
排除标准
- •had received or used an investigational new drug within the 30 days immediately preceding the study
- •used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit
- •used topical medication of any kind on the hair for a period of 48 hours prior to the visit
- •had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
- •Female subjects that were pregnant or breast feeding
结局指标
主要结局
Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100).
时间窗: 14 or 15 days after 1st treatment
次要结局
- Any adverse events during or after application of the product(up to 7 or 8 d after product application)
研究者
研究点 (2)
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