NCT01358240已完成3 期
A Multi-Center, Randomized, Double-Blind, Vehicle Controlled, Parallel Group Comparison of Econazole Nitrate Foam 1% vs Foam Vehicle and an Evaluator-Blinded Comparison of Econazole Nitrate Foam 1% and Econazole Nitrate Cream 1% in Subjects With Interdigital Tinea Pedis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AmDerma
- 入组人数
- 336
- 试验地点
- 12
- 主要终点
- Complete Cure
研究概览
简要总结
This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
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
- Double (Participant, Investigator)
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
- •Be at least 12 years of age and of either sex.
- •Have a clinical diagnosis of interdigital tinea pedis involving at least 2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms (Section 10.1) at baseline.
- •Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.
- •Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
- •Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered into the study pending the results of the fungal
- •Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
- •Females must be non-pregnant (confirmed by a negative urine pregnancy test (UPT) at baseline), non-lactating and not intending to become pregnant during the course of the study.
排除标准
- •Is pregnant nursing or planning a pregnancy during the study.
- •Has used topical antifungals or topical corticosteroids on the feet within 30 days prior to the start of the study.
- •Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
- •Has used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.
- •Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- •Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type tinea pedis, etc. (in the opinion of the Investigator).
- •Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
- •Has any other skin disease which might interfere with the evaluation of tinea pedis.
- •Is currently enrolled in an investigational drug or device study.
- •Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
- •Is unreliable, including subjects with a history of drug or alcohol abuse.
- •Has known hypersensitivity to any of the components of the study medications.
研究组 & 干预措施
Econazole Nitrate Foam 1%
Experimental
Study medication
干预措施: Econazole Nitrate Foam 1% (Drug)
Vehicle Foam
Placebo Comparator
Placebo medication
干预措施: Vehicle Foam (Drug)
Econazole Nitrate Cream 1%
Active Comparator
Econazole Nitrate Cream 1%
干预措施: Econazole Nitrate Cream 1% (Drug)
Placebo Cream
Sham Comparator
Placebo Cream
干预措施: Placebo Cream (Other)
结局指标
主要结局
Complete Cure
时间窗: Day 43
Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.
次要结局
- Effective Treatment(Day 43)
- Mycological Cure(Day 43)
研究者
研究点 (12)
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