Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Number of Participants Free of Live Head Lice and Free of Viable Eggs
研究概览
简要总结
- To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
- To evaluate the safety of LiceMD in a pediatric population.
详细描述
Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject Inclusion Criteria
- •Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.
- •Male or female child; age 3 - 12
- •Willing to participate in study, and parent/guardian sign informed consent
- •Parent/guardian must be able to read and follow directions and complete all questionnaires
- •For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study.
排除标准
- •No live lice, only eggs.
- •Less than three live lice observed with less than ten viable eggs
- •No hair on the head
- •Buzz cut or crew cut
- •Use of other lice treatment or home remedy lice treatment within the past 4 weeks
- •Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events
- •Currently taking an antibiotic
- •Does not follow instructions.
研究组 & 干预措施
LICEMD
Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
干预措施: LICEMD (Drug)
Standard Head lice product
Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
干预措施: Standard Head lice product (Drug)
结局指标
主要结局
Number of Participants Free of Live Head Lice and Free of Viable Eggs
时间窗: Day after first treatment and Day 14 of study
A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14. At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.
次要结局
未报告次要终点