NCT00781820已完成3 期
A Double-blind, Randomized, Multicenter, Placebo- Controlled Phase 3 Trial to Prove the Superiority of Bifonazole vs. Placebo After 4 Weeks of Onychomycosis Treatment/ as a Follow-up of a 2 Weeks Treatment of Non-surgical Nail Ablation of Diseased Nail Matrix With 40% Urea Paste
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
- Bayer
- 入组人数
- 693
- 主要终点
- Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative
研究概览
简要总结
The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least 18 years;
- •Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);
- •Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;
- •Nail mycosis with an affected nail area between 20% and 50% in the target nail,
- •Nail mycosis in not more than 3 nails (each nail not more than 50% infected area)
排除标准
- •Doubtful or negative mycological findings;
- •Proximal subungual onychomycosis (PSO);
- •Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening;
- •Systemic antimycotic treatment within 12 weeks prior to screening;
- •Failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline);
- •Tinea pedis/manus at visit 1 (baseline);
- •Uncontrolled diabetes mellitus
- •Psoriasis
- •Peripheral arterial disease
- •Chronic venous insufficiency;
- •Diabetic neuropathy;
- •History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;
- •Known sensitivity to plasters.
研究组 & 干预措施
Arm 2
Placebo Comparator
干预措施: Placebo cream (Drug)
Arm 1
Experimental
干预措施: Bifonazole cream 1% (Drug)
结局指标
主要结局
Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative
时间窗: 14 days after end of treatment (=visit 3)
次要结局
- Clinical cure rate(14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5))
- Culture negative(6 months after end of treatment (=visit 5))
- Microscopy negative(14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5))
- Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4(3 and 6 months after end of treatment (=visit 4 and 5))
- Mycological cure rate (microscopy + culture negative)(3 and 6 months after end of treatment (=visit 4 and 5))
- Incidence of adverse events(2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5))
研究者
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