A Randomized, Single-Dose, Parallel Group, Comparative Pharmacokinetic (PK) Study to Evaluate Malathion Gel 0.5% Versus Ovide (Malathion) Lotion 0.5% in Patients With Pediculosis Capitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Measurement of blood and urinary levels of malathion and metabolites
研究概览
简要总结
In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc. The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.
详细描述
A randomized, single-dose, parallel group, comparative PK study. Patients will be randomly assigned in 1:1 ratio to the study products. Twenty four (24) consenting patients, age 18 years and older, who meet Inclusion/Exclusion criteria will be enrolled in this study. 12 Patients will be treated with Malathion Gel, 0.5% and other 12 Patients will be treated with Ovide Lotion 0.5%. The study will be single centre and conducted only in India. The primary objective of this study is to compare the systemic exposure of Malathion 0.5% Gel manufactured by Taro Pharmaceuticals USA, Inc. to that of the OVIDE Lotion 0.5%, currently marketed by Taro Pharmaceutical USA, Inc., in adult Patients with head lice. The secondary objective is to determine the link between the exposure and cholinesterase activity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female
- •Patients 18 years of age or older and healthy presenting with Pediculosis capitis
- •The Patient must be willing to consent to the Patient's treatment with Malathion Gel 0.5% or Ovide Lotion 0.5% and for blood drawings before and after medication administration.
排除标准
- •Individuals with history of irritation or sensitivity to pediculicides or hair care products
- •Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, or Sponsor, will interfere with the evaluation.
- •Individuals previously treated with a pediculicide within 4 weeks of the study.
- •Individuals who exhibit potential signs and symptoms of cholinesterase inhibition.
- •Patients currently receiving sulfonamide antibiotics or ivermectin.
研究组 & 干预措施
Malathion gel 0.05%
Malathion gel 0.5% topical treatment for head lice
干预措施: Malathion gel 0.5% (Drug)
Malathion lotion 0.5%
Malathion lotion 0.5% treatment for head lice
干预措施: Malathion lotion 0.5% (Drug)
结局指标
主要结局
Measurement of blood and urinary levels of malathion and metabolites
时间窗: 48 hours
次要结局
- Measure cholinesterase levels and compare to malathion metabolite levels(48 hours)