EUCTR2007-001028-11-PL进行中（未招募）不适用
A double-blind, placebo-controlled study of efficacy, safety and tolerability of topical Kaprolac® K70 in six months treatment of distal subungual onychomycosis (DSO) - Moberg Derma 2
Moberg Derma AB0 个研究点目标入组 705 人开始时间: 2007年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 705
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Male or female (including fertile women)
- •·18 years or older
- •·Distal subungual onychomycosis of finger(s) and/or toe(s) affecting = 75% of the nail bed
- •·Positive culture for dermatophytes (Trichofyton species i.e. T. rubrum or T. mentagrophytes)
- •·Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Proximal subungual onychomycosis
- •·Distal subungual onychomycosis of finger(s) and/or toe(s) where involvement has extended into the proximal portion of the nail, or distal subungual onychomycosis of finger(s) and/or toe(s) affecting >75% of the nail bed
- •·Conditions known to cause abnormal nail appearance
- •·Topical treatment of the nails with other antifungal medication within 1 month before screening
- •·Systemic use of antifungal treatment within 3 months before screening
- •·Signs of severe peripheral circulatory insufficiency
- •·Immunosuppression
- •·Participation in another clinical nail study during the previous 3 months
- •·Known allergy to any of the tested treatment products or to surgical tape occlusion
研究者
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