EUCTR2015-000561-31-SE进行中（未招募）1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, VEHICLE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF P-3058 10% NAIL SOLUTION IN THE TREATMENT OF ONYCHOMYCOSIS
Polichem S.A.0 个研究点目标入组 980 人开始时间: 2015年7月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 980
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
- •- Written informed consent before starting any study related procedures.
- •- Patients aged 12 to 80 years old of any race.
- •- Males or females.
- •- Patients with onychomycosis involving = 20% to = 50% of the area of the target big toenail.
- •- Patients with a positive KOH examination in the screening target big toenail sample.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 490
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 390
排除标准
- •- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- •- Presence of yellow spikes” (defined as longitudinal streak extending from the free edge of the nail to the proximal edge) on the target nail.
- •- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
- •- Presence of nail thickness exceeding 2 mm.
- •- Patients with proximal subungual involvement (marker of immunosuppressed patient).
- •- Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate).
- •- Patients with nail abnormalities due to conditions like psoriasis, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease.
- •- Patients with life expectancy less than 2 years.
- •- Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
- •- Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
- •- HIV infection or any other immunodeficiency.
- •- Alcohol or substance abuse.
- •- Patients with history of allergic reactions to terbinafine or its excipients.
研究者
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