A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The proportion of subjects lice free at the end of the study (Day 10)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.
详细描述
The primary objective of the study was to compare the safety and efficacy of X92001327 versus RID in subjects with head lice. The subjects received a single application on Day 0 of either X92001327 or RID shampoo based on the randomization schedule. A repeat application of the test product was administered on Day 7. Subjects visited the clinic four times: on Day 0, Day 1, Day 7 and Day 10.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over the age of 1 at the time of signing the informed consent or giving assent
- •Have an active head lice infestation of at least 5 live lice and 5 viable nits
- •subject must be capable of understanding and providing written informed consent
- •agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
- •agree not to use a lice comb during the study
- •the parent or guardian of a child must be willing to have other family members screened for head lice.
- •have a single place of residence
排除标准
- •used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
- •used any topical medication of any kind for a period of 48 hours prior to the screening visit
- •individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
- •has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
- •individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
- •individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits
- •females who are pregnant or nursing
- •patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks
- •subjects with hair longer than mid back
结局指标
主要结局
The proportion of subjects lice free at the end of the study (Day 10)
时间窗: Day 10
Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).
次要结局
- The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)(Day 1, Day 7)