A Multi-Center Phase III Study to Evaluate Ovide Lotion 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)
研究概览
简要总结
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
详细描述
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.
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
- 否
入选标准
- •Confirmed active head lice infestation
排除标准
- •Allergy to pediculicides or hair care products
- •Scalp conditions other than head lice
- •Previous head lice treatment within the past 4 weeks
- •Current antibiotic treatment
研究组 & 干预措施
Malathion Gel
Malathion gel 0.5% 30 minute application
干预措施: Malathion gel 0.5% (Drug)
Nix Creme Rinse
Nix applied to scalp for 10 minutes
干预措施: Permethrin 1% rinse (Drug)
结局指标
主要结局
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)
时间窗: 3 weeks
Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).
时间窗: 3 weeks
Treatment Success in the Modified ITT (non-LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF
Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment
时间窗: 3 weeks
Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF) The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).
Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment
时间窗: 3 weeks
Treatment Success in the Per Protocol Population (PPP) The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.
Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.
时间窗: 3 weeks
Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive. The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7). Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))
次要结局
- Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)(3 weeks)
- Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))(3 weeks)
- Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))(3 weeks)
- Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP(3 weeks)
- Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)(3 weeks)