NCT00869336已完成2 期
Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis
Tinea Pharmaceuticals0 个研究点目标入组 147 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 主要终点
- Proportion of subjects who achieve complete clearance at 2 weeks post treatment
研究概览
简要总结
To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either gender must be 12 years of age or older.
- •Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
- •Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount
- •Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception
排除标准
- •Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;
- •Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
- •Subjects who are immunocompromised (due to disease, e.g., HIV or medications
- •Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
- •Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- •Subjects using the following medications:
- •topical antifungal agent within 30 days of the baseline visit
- •systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine)
- •topical corticosteroid in treatment area(s) within 30 days of the baseline visit.
- •systemic corticosteroids within 30 days of the baseline visit;
- •any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.
研究组 & 干预措施
Luliconazole Cream 1% - 2 wks
Experimental
Daily treatment with Luliconazole Cream 1% for 2 weeks
干预措施: Luliconazole Cream 1% - 2 wks (Drug)
Luliconazole Cream 1% - 4 wks
Experimental
Daily treatment with Luliconazole Cream 1% for 4 weeks
干预措施: Luliconazole Cream 1% - 4 wks (Drug)
Placebo Comparator - 2 wks
Placebo Comparator
Daily treatment with Vehicle Cream for 2 weeks
干预措施: Placebo Comparator -2 wks (Drug)
Placebo Comparator - 4 wks
Placebo Comparator
Daily treatment with Vehicle Cream for 4 weeks
干预措施: Placebo Comparator - 4 wks (Drug)
结局指标
主要结局
Proportion of subjects who achieve complete clearance at 2 weeks post treatment
时间窗: Two weeks post treatment
次要结局
- Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment(2 and 4 weeks post treatment)
研究者
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