NCT01014637Unknown4 期
A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement
Pierre Fabre Dermo Cosmetique3 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 260
- 试验地点
- 3
- 主要终点
- To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement
研究概览
简要总结
The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.
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) without matrix involvement
- •Target nail plate showing between 25% and 60% of clinically infected area
- •Patient must have at least 2 mm of unaffected proximal target nail area
- •Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
- •Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
- •Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit
排除标准
- •Patient with more than 3 affected nails
- •Patient with onychomycosis with matrix involvement
- •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 any topical antifungal therapy applied to the toenails within 3 months prior to screening visit
- •Patient with known hypersensitivity to investigational products' ingredient(s)
- •Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit
研究组 & 干预措施
Amorolfine 5%
Active Comparator
干预措施: Amorolfine (Antifungal) (Drug)
RV4104A-cylcopiroxolamine-ciclopirox
Experimental
干预措施: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) (Drug)
结局指标
主要结局
To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement
时间窗: Day 336
次要结局
- To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement(Day 21, Day 77, Day 156, Day 262)
- To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement(Day 336)
- To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement(Day 77, Day 168, Day 252)
- Averse Events Reporting(Throughout the study)
研究者
研究点 (3)
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