NCT02010333已完成2 期
A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Safety and tolerability of Ha44 Gel
研究概览
简要总结
The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 6months < 3years of age
- •Good health
- •Active head lice infestation defined as the presence of at least 3 live lice
- •Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
- •Parent/guardian agrees to allow PK samples collected
- •Signed Informed Consent Form
排除标准
- •Condition or illness that in the opinion of the investigator may interfere with the study results.
- •Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
- •Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- •Receiving systemic or topical medication that may interfere the study results.
- •Received an investigational agent within 30 days prior to Day 0.
研究组 & 干预措施
Ha44 Gel 0.74% w/w
Experimental
Open label, one arm
干预措施: Ha44 Gel 0.74% w/w (Drug)
结局指标
主要结局
Safety and tolerability of Ha44 Gel
时间窗: 8 months
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Trial of HRS-9813 in Healthy VolunteersHealthy VolunteersNCT06514963Guangdong Hengrui Pharmaceutical Co., Ltd50
已完成
1 期
A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic CardiomyopathyObstructive Hypertrophic CardiomyopathyNCT05879523Shandong Suncadia Medicine Co., Ltd.76
已完成
1 期
Study of XH-S003 in Healthy VolunteersHealthy AdultsNCT06272747S-INFINITY Pharmaceuticals Co., Ltd36
招募中
1 期
A Phase I Study of XH-S002 in Healthy VolunteersHealthy AdultsNCT06204419S-Infinity Pharmaceuticals Co., Ltd86
已完成
1 期
Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male VolunteersHealthyNCT01869985Hanmi Pharmaceutical Company Limited30