A Multi-Center, Randomized Comparative Study of the Pharmacokinetics of Econazole Nitrate 1% Foam and Econazole Nitrate 1% Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AmDerma
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Plasma Levels of Econazole Nitrate
研究概览
简要总结
To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.
详细描述
Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle in adults, the current clinical study is being conducted to provide additional pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in this pediatric population. The study also includes clinical and safety endpoints.
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 12 years and less than 18 years of age and of either sex.
- •Have a clinical diagnosis of interdigital tinea pedis
- •Parent/guardian has provided written informed consent and the subject has provided written assent.
- •Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
- •Have microscopic evidence (positive KOH) of the presence of fungi and a positive fungal culture.
- •Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
- •Females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study.
排除标准
- •Is pregnant, nursing or planning a pregnancy during the study
- •Has used topical antifungals or topical corticosteroids on the feet within 14 days prior to the start of the study.
- •Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
- •Has used systemic antibacterials or systemic corticosteroids within 14 days prior to the start of the study.
- •Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- •Has concurrent moccasin-type tinea pedis (in the opinion of the Investigator).
- •Has any other skin disease which might interfere with the evaluation of tinea pedis.
- •Is currently enrolled in an investigational drug or device study.
- •Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
- •Is unreliable, including subjects with a history of drug or alcohol abuse.
- •Has known hypersensitivity to any of the components of the study medications.
研究组 & 干预措施
Econazole Nitrate Foam
Investigational Drug Product
干预措施: Econazole Nitrate (Drug)
Vehicle Foam
Vehicle Foam Comparator
干预措施: placebo (Drug)
Econazole Nitrate Cream
Active comparator cream product
干预措施: Econazole Nitrate (Drug)
结局指标
主要结局
Plasma Levels of Econazole Nitrate
时间窗: 28 Days
Blood will be taken at Baseline (Day 1) prior to the application of medication, and at the end of treatment (Day 28), just prior to the last dose of medication, and at 7 (±1 hr) hours post-drug application and a third blood draw 4 (±1 hr) hours after the second PK blood draw.
Investigator Assessment of Response to Treatment
时间窗: 28 Days
At the end of treatment (Day 28), the Investigator will assess the subject's response to treatment using a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, and 5 = poor).
次要结局
- Dosing Compliance(28 Days)