A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Clinical Cure
研究概览
简要总结
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
详细描述
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
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
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
- •Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed.
- •Infestation with head lice as demonstrated by the presence of live lice prior to first treatment.
- •Willing and able to attend all study visits as scheduled.
- •Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.
排除标准
- •Subject and/or legal guardian has not signed informed consent.
- •Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.
- •Subject with an infestation of body lice or pubic lice.
- •Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study.
- •Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation.
- •Subject with very short (shaved) hair.
- •Subject who will not be available for follow up visits.
- •Subject has been treated with a systemic antibiotic within the previous two weeks before screening.
- •Subject has been previously enrolled in any clinical study within the past 30 days; subject may not participate in another study while participating in this study.
- •Subject with history of allergy/sensitivity to active ingredient or related products; or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
- •Pregnant and/or nursing females.
研究组 & 干预措施
1
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
干预措施: BGC20-0582 (Drug)
2
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
干预措施: BGC20-0582 (Drug)
3
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
干预措施: BGC20-0582 (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure
时间窗: Day 15 or 22
Count of participants with No live lice
次要结局
未报告次要终点