NCT00244439已完成3 期
A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Cure of Head Lice
研究概览
简要总结
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
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
- •Patient, parent or guardian must be able to apply the treatment
- •Entire household must be screened
- •All infested persons must agree to participate
排除标准
- •Allergy to pediculicides, hair care products or chrysanthemums
- •Scalp conditions other than head lice
- •Previous head lice treatment within the past 4 weeks
- •Female patients who are pregnant or nursing
研究组 & 干预措施
3
Active Comparator
Permethrin 1%
干预措施: Permethrin 1% (Drug)
1
Experimental
MALG
干预措施: MALG (Drug)
2
Active Comparator
Ovide
干预措施: Ovide (malathion) lotion 0.05% (Drug)
结局指标
主要结局
Cure of Head Lice
时间窗: 4 weeks
次要结局
- Safety of treatments(4 weeks)
研究者
研究点 (1)
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