A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
研究概览
简要总结
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
- •Participants of either gender must be at least 2 years to less than (<) 18 years of age (2 to 17 years, inclusive).
- •Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
- •Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
- •Participants/caregiver must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
排除标准
- •Participants with active atopic or contact dermatitis in the area to be treated.
- •Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
- •Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start study drug will be discontinued from study drug but will be followed for safety purposes.
- •Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications).
- •Participants who have a recent history of or current drug or alcohol abuse.
研究组 & 干预措施
Luliconazole Cream 1%
Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
干预措施: Luliconazole Cream 1% (Drug)
Vehicle Cream
Vehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
时间窗: 6 hours after the final dose of the drug on Day 7
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
时间窗: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).
次要结局
未报告次要终点