An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
研究概览
简要总结
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
详细描述
Study population, diagnosis, and main criteria for inclusion:
Tinea pedis and Tinea cruris (NAFT-500):
Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
Tinea pedis (NAFT-600):
Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection.
- •Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.
排除标准
- •A known hypersensitivity to study medications or their components
- •Any severe condition of Tinea pedis (incapacitating)
- •Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis
- •Positive pregnancy test
- •Any history or current evidence (physical or laboratory) of anemia
研究组 & 干预措施
NAFT500 (pediatric)
Topical once a day for two weeks
干预措施: NAFT500 (pediatric) (Drug)
NAFT600 (pediatric)
Topical once a day for two weeks
干预措施: NAFT600 (pediatric) (Drug)
NAFT500 (adult)
Topical once a day for two weeks
干预措施: NAFT500 (adult) (Drug)
NAFT600 (adult)
Topical once a day for two weeks
干预措施: NAFT600 (adult) (Drug)
结局指标
主要结局
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
时间窗: Day 1 and Day 14
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).
次要结局
- Efficacy Variables(Day 28)