NCT02547701已完成3 期
Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis
Polichem S.A.2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Local tolerability
研究概览
简要总结
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age between 2 to 17 years
- •Males and females
- •Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
- •Positive mycroscopy examination from the target nail at screening.
- •Positive culture for dermatophyte from the target nail at screening.
排除标准
- •Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
- •Patients with nail psoriasis.
- •Patients with nail changes due to eczema, lichen planus or alopecia areata.
- •Patients with one-hand two-foot syndrome.
- •Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
- •Use of systemic antifungal drugs in the 6 months prior to screening visit.
- •Use of topical nail antifungal drugs in the four weeks prior to screening visit.
研究组 & 干预措施
P-3058
Experimental
干预措施: P-3058 (Drug)
结局指标
主要结局
Local tolerability
时间窗: from week 4 up to maximum week 48 of treatment
Local tolerability at all treated nails by means of the Severity Score for Skin Irritation
次要结局
未报告次要终点
研究者
研究点 (2)
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