A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Demonstration of Bioequivalence in proportion of index subjects who are lice free
研究概览
简要总结
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%
详细描述
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
- •Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
排除标准
- •Subjects with a history of hypersensitivity or allergy to or any component of the study product.
- •Subject with history of irritation or sensitivity to pediculicides or hair care products.
研究组 & 干预措施
Ivermectin Lotion, 0.5%
One 10 minute application, under at-home use conditions
干预措施: Ivermectin Lotion, 0.5% (Drug)
SKLICE (ivermectin) Lotion, 0.5%
One 10 minute application, under at-home use conditions
干预措施: SKLICE (ivermectin) Lotion, 0.5% (Drug)
Vehicle of the Test product
One 10 minute application, under at-home use conditions
干预措施: Vehicle of the Test product (Drug)
结局指标
主要结局
Demonstration of Bioequivalence in proportion of index subjects who are lice free
时间窗: Day 15 (14 days after application of study treatment)
Demonstration of Bioequivalence in proportion of index subjects who are lice free
次要结局
未报告次要终点