NCT00808366Unknown不适用
A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)
- •Target nail plate showing ≥ 12.5% of clinically infected area
- •Patient must have at least 2 mm of the proximal end of the target nail free of infection
- •Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)
排除标准
- •Patient with more than 2 affected toenails
- •Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
- •Patient with moccasin-type tinea pedis
- •Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit
研究组 & 干预措施
RV4104A ointment
Experimental
干预措施: Keratolytic/Antifungal (Drug)
bifonazole-urea ointment
Active Comparator
干预措施: Keratolytic/Antifungal (Drug)
结局指标
主要结局
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs
时间窗: D21
次要结局
- Clinical cure(D77, D105)
- Mycological cure(D105)
- Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation(D21)
- Patient self-assessment(D21, D77, D105)
- Complete cure of onychomycosis(D105)
- Local tolerability(D7, D21)
- Adverse Event reporting(Throughout the study)
研究者
研究点 (1)
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