A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flutrimazole 1% cream Vs. Terbinafine Hydrochloride 1% cream in patients with Dermatomycoses.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles
研究概览
简要总结
This study is a randomized, comparative, double blind and multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flutrimazole 1% cream Vs Terbinafine Hydrochloride cream for 28 days in 200 patients with Dermatomycoses that will be conducted in three centers. Date of first enrollment will be 2 March, 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome measures will be assessment by grading Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles at day 0, Day 7, Day 14 and Day 28. Mycological assessment, Global assessment of treatment and safety and tolerability will be done as secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of Dermatomycoses confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
- •Written informed consent by patient.
- •Patient willing to follow up.
排除标准
- •Pregnant or nursing females.
- •Patients with severe chronic diseases.
- •Individuals who present a history of hypersensitivity to other antifungal imidazolic, or any of the components of the pharmaceutical form used.
- •Patients who might have required concomitant medication with other antimycotics administered by another route.
结局指标
主要结局
Ring-like lesion, Scaling, Erythema, Burning, Itching and Vesicles
时间窗: Day 0, Day 7, Day 14 and Day 28.
次要结局
- Global Assessment of treatment(Day 28)
- Mycological assessment(Day 0 and Day 28)
- Safety and Tolerability(Day 0, Day 7, Day 14 and Day 28.)