NCT02624843已完成3 期
Bioequivalence Study for Benzyl Alcohol Lotion 5% (Hi-Tech Pharmacal Co. LTD) and Ulesfia (Benzyl Alcohol Lotion 5%) (Shionogi Inc.) in the Treatment of Head Lice and Their Ova.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Akorn, Inc.
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- Number of Participants With Infestation Successfully Eliminated by Active Treatment.
研究概览
简要总结
To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years.
- •Prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits).
- •Prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study.
- •Prospective participants who will be available for follow up visits over the 21 days following first treatment.
- •Prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test.
- •Prospective participants who agree not to shave their hair or use any other pediculicide, nit combing, or louse treatment method during the course of the study.
排除标准
- •Prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).
- •Prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products.
- •Prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis).
- •Prospective participants who have been treated with other head lice products within 4 weeks prior to randomization.
- •Prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks.
- •Prospective participants who have been treated with Trimethoprim containing products within the previous 4 weeks, or who are currently taking such a course.
- •Females who are pregnant, planning to become pregnant, during the course of the study period, or are currently breast feeding mothers.
- •Females of childbearing potential who are unwilling to use an adequate method of contraception from at least 4 weeks prior to the first application of treatment and until 4 weeks after the last application of treatment, or who are unwilling to take a urine pregnancy test.
- •Prospective participants who have participated in another clinical study or used an investigational new drug within 1 month before entry into this study.
- •Participants who have already participated in this clinical study.
研究组 & 干预措施
Benzyl Alcohol Lotion 5%
Experimental
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
干预措施: Benzyl Alcohol Lotion 5% (Drug)
Ulesfia (Benzyl Alcohol Lotion 5%)
Active Comparator
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
干预措施: Ulesfia (benzyl alcohol lotion) 5% (Drug)
Vehicle Placebo Lotion 0%
Placebo Comparator
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Infestation Successfully Eliminated by Active Treatment.
时间窗: Study Day 22 +/-2
Successful elimination of infestation by active treatment \[Time frame: 22 + 2 days\]. No evidence of active head lice infestation 22 days after enrollment.
次要结局
未报告次要终点
研究者
研究点 (2)
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