NCT01814020已完成2 期
An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.
研究概览
简要总结
Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.
研究设计
- 研究类型
- Interventional
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.
- •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
- •History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
- •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 devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)
结局指标
主要结局
The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.
时间窗: At 60 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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