EUCTR2008-002399-92-DE
进行中（未招募）
不适用
A phase IIa randomised, observer-blind, comparative study of the efficacy, tolerability and consumer acceptability of topical MedSpray™ TP 1 % versus Lamisil® Once 1 % in the treatment of tinea pedis - Tinea Pedis
MedPharm Ltd.0 个研究点2008年7月23日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- tinea pedis
- 发起方
- MedPharm Ltd.
- 状态
- 进行中（未招募）
- 最后更新
- 13年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •All of the following criteria have to be met for inclusion of a subject in the study:
- •men and women aged 18 years or over;
- •presence of interdigital tinea pedis caused by dermatophytes on one or both feet, characterized by physician’s global assessment score of 2 (notable signs and symptoms exist”) or 3 (prominent signs and symptoms exist”) at baseline
- •the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •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
- •Patients are to be excluded from the study when one or more of the following conditions are met:
- •patients aged under 18 years;
- •patients with hyperkeratotic chronic plantar tinea pedis (moccasin type);
- •patients who are immunosuppressed (includes patients receiving radiation therapy or systemic therapy with cytostatic or immunosuppressive drugs at time of study or within the 2 weeks prior to entry);
- •patients who had active treatment in the last 2 weeks before entry, or are currently undergoing active treatment for another dermatomycosis with a drug other than the study drugs;
- •patients with diabetes;
- •patients with compromised circulation;
- •patients who have been treated with oral anti\-fungal agents within the 12 weeks prior to study entry or treated with topical anti\-fungal agents on the feet within the previous 2 weeks;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
结局指标
主要结局
未指定
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