NCT01013909已完成2 期
An Investigator-blind, Randomized, Multicenter, 5-arm, Placebo- and Active Controlled Parallel Group Pilot Trial to Explore the Efficacy and Tolerability of Topical Bifonazole Liquid Spray in Patients With Athlete's Foot.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 220
- 主要终点
- Assessment of erythema, scaling, vesiculation maceration, and pruritus based on a categorial scale (0=absent to 3 =severe), assessment of mycological cure based on cultures and microscopy
研究概览
简要总结
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged between 18 and 70 years
- •Positive clinical findings of athlete's foot, limited to interdigital spaces, with a total athlete's foot severity score (AFSS) of at least 5 and not exceeding 10 points for the signs and symptoms of athlete's foot, and no sign or symptom scoring 'severe'
排除标准
- •Clinical history suggestive of intolerance or allergies to one of the products or the ingredients of the products
- •Plantar tinea pedis ("Mocassin-type")
- •Onychomycosis of any toe
- •Previous treatment with a systemic antifungal within 6 months prior to screening
- •Previous treatment of feet with a topical antifungal within 4 weeks prior to screening
- •Previous treatment with a topical antifungal applied to other areas of the body than feet within 2 weeks prior to screening
- •Previous treatment of any topical medication applied to the feet within 2 weeks prior to screening
研究组 & 干预措施
Arm 5
Active Comparator
干预措施: Lamisil Once (Drug)
Arm 1
Experimental
干预措施: Bifonazole spray once daily (Drug)
Arm 2
Experimental
干预措施: Bifonazole spray twice daily (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
Arm 4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of erythema, scaling, vesiculation maceration, and pruritus based on a categorial scale (0=absent to 3 =severe), assessment of mycological cure based on cultures and microscopy
时间窗: After 6 applications (7 and 42 days after start of treatment)
Local side effects on the skin
时间窗: From day 1 through day 42
次要结局
- Clinical cure(After 6 applications (7 and 42 days after start of treatment))
- Mycological cure(After 6 applications (7 and 42 days after start of treatment))
- Rate of negative culture(After 6 applications (7 and 42 days after start of treatment))
- Rate of microscopy negative(After 6 applications (7 and 42 days after start of treatment))
- Incidence and severity of Adverse Event(From visit 2 (day 3) till visit 7 (day 42))
- Vital Signs(Visit 1 (day 1) and visit 7 (day 42))
- Rate of absence of itching and burning(After 6 applications (7 and 42 days after start of treatment))
- Local side effects(From visit 2 (day 3) till visit 7 (day 42))
研究者
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