NCT01336647已完成2 期
An Efficacy and Safety 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
- 142
- 试验地点
- 2
- 主要终点
- Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
研究概览
简要总结
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •2 years of age or older
- •Body weight of at least 33 pounds
- •Has an active head lice infestation at Day
- •An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members
- •Belong to a household of no more than 6 members, except where additional household members are < 2 years of age
- •Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation
- •Female subjects must be:
- •of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or, post-menopausal for at least 2 years) OR,
- •if of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit.
排除标准
- •Had treatment for head lice within 14 days prior to Day 0
- •Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment
- •Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results
- •Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment
- •Has been using hormonal contraception for less than 3 months or is pregnant or lactating
- •Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study
- •Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results
- •Has received an investigational agent within 30 days prior to Day 0
研究组 & 干预措施
Group A
Experimental
Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
干预措施: Group A - Low-Dose Ha44 0.37% w/w (Drug)
Group B
Experimental
Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.
干预措施: Group B - High Dose Ha44 Gel 0.74% w/w (Drug)
Group C
Placebo Comparator
Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
干预措施: Group C - Placebo (Drug)
结局指标
主要结局
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
时间窗: Follow up visit at days 1, 7 and 14 days
次要结局
- Safety and Tolerability of Ha44 Gel(From treatment to last visit of the study at 14 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice InfestationHead Lice InfestationNCT01907490Dr. Reddy's Laboratories Limited38
已完成
2 期
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungAdenocarcinomaNCT02875340ValiSeek Limited8
招募中
2 期
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System TumorsUrinary System TumorSolid TumorNCT05785039Sichuan Baili Pharmaceutical Co., Ltd.76
进行中（未招募）
2 期
Safety and Efficacy of APG-157 in Head and Neck CancerHead and Neck CancerSquamous Cell Carcinoma of Oral CavitySquamous Cell Carcinoma of the OropharynxNCT05312710Aveta Biomics, Inc.24
进行中（未招募）
1 期
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D MutationAdvanced KRAS G12D Mutant Solid TumorsNCT06385678Jiangsu HengRui Medicine Co., Ltd.47