NCT00857935已完成2 期
A Pilot Study to Test the Operational Elements of an Actual Use Study Designed to Compare the Safety and Efficacy of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months of Age or Older With Pediculosis Capitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ParaPRO LLC
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment.
研究概览
简要总结
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
详细描述
A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.
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
- Double (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
- 是
入选标准
- •Male or female, 6 months of age or older
- •Subject must have a head lice infestation present at baseline
- •Subject/caregiver must read English or Spanish at a 7th grade level
- •Subject must have an appropriately signed Informed Consent agreement
- •Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
- •Subject agreement to not use any other form of lice treatment during the course of the study
- •Subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits
排除标准
- •Individuals with a history of irritation or sensitivity to pediculicides or hair care products
- •Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
- •Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
- •Individuals receiving systemic or topical drugs that may interfere with the study results
- •Individuals who have participated in a clinical trial within 30 days of enrollment
- •Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment
- •Females who are pregnant or nursing
- •Sexually-active females not using effective contraception
研究组 & 干预措施
1
Experimental
NatrOVA Creme Rinse - 1%
干预措施: NatrOVA Creme Rinse - 1% (Drug)
2
Active Comparator
NIX Creme Rinse
干预措施: NIX Creme Rinse - 1% permethrin (Drug)
结局指标
主要结局
Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment.
时间窗: 14 days after last treatment
次要结局
- Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment.(14 days after last treatment)
研究者
研究点 (1)
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