NCT01246518已完成2 期
An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.
研究概览
简要总结
Onychomycosis is a fungal infection that affects fingernails and/or toenails.
The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.
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
- None
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
- •18 - 70 years
- •DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization)
- •Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
- •Signed written informed consent
排除标准
- •Proximal subungual onychomycosis
- •DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
- •"Spike" of onychomycosis extending to eponychium of the target nail
- •Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
- •Other conditions than DSO known to cause abnormal nail appearance
- •Topical antifungal treatment of the nails 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 trial with an investigational drug or device during the previous 4 weeks before screening
- •Known allergy to any of the tested treatment products
- •A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
- •Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :
- •are pregnant or nursing
- •are not surgically sterile
- •are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine
研究组 & 干预措施
MOB015 for 3 months
Active Comparator
干预措施: MOB015 (Drug)
MOB015 for 9 months
Active Comparator
干预措施: MOB015 (Drug)
结局指标
主要结局
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.
时间窗: 12 months
次要结局
- Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.(1, 3, 6, 9, 12 months.)
研究者
研究点 (1)
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