A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

Moberg Pharma AB0 个研究点目标入组 75 人开始时间: 2010年9月最近更新: 2013年6月26日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Moberg Pharma AB
入组人数: 75
主要终点: Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.

研究概览入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.

研究设计

研究类型: Interventional

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

•Male or female patients aged 18 years or older
•25%-75% of the target nail altered as a result of onychomycosis
•Signed written informed consent
•Exclusion criteria
•Proximal subungual onychomycosis
•Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101
•Other conditions known to cause abnormal nail appearance
•Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.
•Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.
•Known allergy to any of the tested treatment products

排除标准

未提供

结局指标

主要结局

Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.

次要结局

未报告次要终点

研究者

发起方

Moberg Pharma AB

申办方类型

Industry

责任方

Sponsor

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