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 个研究点开始时间: 2008年7月23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
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
- •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;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •treatment with any other investigational drug in the four weeks preceding the study;
- •patients with known hypersensitivity to terbinafine or any of the test or comparator product excipients (see appendix A of study protocoll);
- •treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. antihistamines or glucocorticosteroids);
- •contraindications according to summary of product characteristics of Lamisil® Once or according to IB on MedSprayTM TP 1 %
研究者
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