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临床试验/EUCTR2007-001028-11-SE
EUCTR2007-001028-11-SE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 个研究点开始时间: 2007年3月30日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

发起方
Moberg Derma AB

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