NCT01105013Unknown3 期
Study Clinical, Multicenter, Phase III, to Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Like Tinea Foot, Tinea and Tinea Crural Body"
Laboratório Teuto Brasileiro S/A1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.
研究概览
简要总结
This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.
详细描述
Study Clinical, multicenter, Phase III, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients of both sexes, of any race, aged 12 years;
- •Ability to understand and sign the IC (for patients older than age) in the case of minors monitoring and consent of a guardian;
- •Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas);
- •Direct mycological exam positive for fungi;
排除标准
- •Pregnant women or nursing mothers;
- •Use of topical or oral antifungal;
- •Use of steroids;
- •Allergy or hypersensitivity to any component of product;
- •Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.
研究组 & 干预措施
tonaftato
Experimental
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
干预措施: Clotrimazole (Drug)
结局指标
主要结局
Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.
时间窗: 97 days
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
次要结局
未报告次要终点
研究者
研究点 (1)
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