NCT01419847已完成4 期
A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mycological cure or global evaluation of 2 or less Mycological Cure
研究概览
简要总结
Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.
详细描述
Therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of two and sixteen years
- •Clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate
- •Positive DTM reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold
- •Consent to participate in the study
- •Women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study.
排除标准
- •Children with allergy to Penlac or one of its ingredients
- •Structural deformity of target nail plate
- •Presence of active psoriasis or severe foot eczema
- •Presence of immunodeficiency disorder
- •Concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months
- •Previous systemic antifungal therapy within the last 6 months
- •Previous topical antifungal therapy within the last 14 days
- •Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant
研究组 & 干预措施
topical Penlac nail lacquer
Active Comparator
3-1 randomization of active to placebo
干预措施: Ciclopirox (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mycological cure or global evaluation of 2 or less Mycological Cure
时间窗: Week 20
次要结局
- Estimated cost of therapy
研究者
研究点 (1)
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