NCT02549001已完成3 期
A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis
Polichem S.A.1 个研究点 分布在 1 个国家目标入组 953 人开始时间: 2015年8月20日最近更新:
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
- 953
- 试验地点
- 1
- 主要终点
- Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
研究概览
简要总结
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Patients aged 12 years and older of any race.
- •Males or females.
- •Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
- •Patients with a positive KOH examination and culture positive for dermatophyte
排除标准
- •Presence of "yellow spikes" on the target nail.
- •Presence of dermatophytoma on the target nail.
- •Presence of nail thickness exceeding 2 mm.
- •Patients with proximal subungual involvement
- •Patients with severe plantar or moccasin tinea pedis
- •Patients with nail abnormalities due to other conditions
- •Patients with life expectancy less than 2 years.
- •Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
- •Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
- •HIV infection or any other immunodeficiency.
- •Alcohol or substance abuse.
- •Patients with history of allergic reactions to terbinafine or its excipients.
- •Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
研究组 & 干预措施
P-3058 10%
Experimental
P-3058 10%
干预措施: P-3058 10% (Drug)
vehicle of P-3058 10%
Placebo Comparator
vehicle of P-3058 10%
干预措施: vehicle of P-3058 10% (Drug)
amorolfine 5%
Active Comparator
Loceryl®
干预措施: amorolfine 5% (Drug)
结局指标
主要结局
Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
时间窗: Week 60
次要结局
- Negative culture rate for dermatophytes of the target nail.(Week 60)
- Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.(Week 60)
- Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.(Week 60)
- Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.(Week 60)
研究者
研究点 (1)
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