EUCTR2006-000775-15-CZ进行中（未招募）不适用
Double blind, comparative, randomized, placebo controlled, clinical study of therapeutic equivalence and tolerability of the topical preparation Terbinafine cream 1% (Pliva Croatia) with the medical preparation Lamisil (terbinafine 1% cream), for patients affected from uncomplicated Tinea pedis (Athlete´s Foot).
PLIVA - ISTRAŽIVANJE I RAZVOJ d.o.o.0 个研究点目标入组 770 人开始时间: 2006年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 770
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
- •1.Male and female patients aged between 18-70 years.
- •2.Local finding of uncomplicated Tinea pedis (Athlete´s Foot) confirmed by a microscopy.
- •3.Informed Consent Form, voluntarily signed after being fully informed.
- •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
- •1.Patients with concomitantly treated onychomycosis.
- •2.Patients with onychomycosis on the evaluated foot.
- •3.Patients with plantar mycosis, vesicle-pustular or hyperkeratosquamous.
- •4.Patients concomitantly treated with radiotherapy, systemic chemotherapy or immunosuppression, or patients with such treatment terminated less than two months before being included in the study.
- •5.Patients treated with local antimycotics at any place within the body, within 4 weeks before being included in the study, or with systemic antimycotic therapy within 12 weeks before being included in the study.
- •6.Patients treated with local corticosteroids at the area affected by uncomplicated Tinea pedis within 4 weeks before being included in the study, or with systemic corticosteroid therapy within 12 weeks before being included in the study.
- •7.Patients treated with antihistaminics 30 days before being included in the study.
- •8.Patients with acquired immunodeficiency syndrome (HIV infection).
- •9.Pregnant or breast-feeding female.
- •10.Women of childbearing potential without adequate contraception (barrier, hormonal).
- •11.Patients allergic to any of the substances to be administered during the study.
- •12.Patients unable to cooperate.
- •13.Patients taking part in another study within the past 4 weeks and during this study.
- •14.Patients addicted to alcohol or drugs.
- •15.Patients unwilling to sign an informed consent form.
- •16.Patients with active tuberculosis, known thyroid hyperfunction, diabetes mellitus treated with oral antidiabetics and/or insulin.
- •17.Vulnerable subjects (e.g. soldiers in military service, people depending on the investigator – e.g. subordinates, members of family).
研究者
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