Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ParaPRO LLC
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.
研究概览
简要总结
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
详细描述
A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm, parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of different strengths of Spinosad Creme rinse verses vehicle control.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active head lice infestation
- •Male or female, 2 years of age or older
- •Good general health
- •Appropriately signed Informed Consent
- •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 between visits
排除标准
- •History of irritation or sensitivity to pediculicides or hair care products
- •Individuals with any visible skin/scalp condition that would interfere with the evaluation
- •Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment
- •Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment
- •Individuals who have participated in any clinical trial within 30 days of enrollment
- •Individuals with family members who were infested with lice but were unwilling or unable to enroll in the study or use a standard course of lice treatment
- •Females who were pregnant or nursing
- •Sexually active females not using effective contraception
研究组 & 干预措施
1
Vehicle control
干预措施: Spinosad Creme Rinse - Vehicle Control (Drug)
2
0.5% Spinosad creme rinse
干预措施: Spinosad Creme Rinse (Drug)
3
1.0% Spinosad Creme Rinse
干预措施: Spinosad Creme Rinse (Drug)
4
2.0% Spinosad Creme Rinse
干预措施: Spinosad Creme Rinse (Drug)
结局指标
主要结局
Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.
时间窗: 14 days
次要结局
- Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.(14 days)