A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Naftifine Hydrochloride 1% cream Vs. Terbinafine Hydrochloride 1% cream in patients with Tinea pedis and Tinea cruris.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Itching, Erythema, Scaling/Crusting, Vesicles and papules
研究概览
简要总结
This study is a comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Naftifine Hydrochloride 1% cream Vs Terbinafine Hydrochloride 1% cream (Reference Drug), in 200 patients with Tinea pedis and Tinea cruris. Date of enrollment is 04 Jan 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome measures are change in clinical efficacy parameters i.e. itching, erythema, scaling/crusting, vesicles and papules etc. by four point scales on day 0, 7, 14 and 28. Secondary out come measure is patients and physicians Global Assessment of treatment efficacy and tolerability at 28th day and overall response by mycological assessment (KOH mount) at day 0 and day 28.
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
- •Males and female patients with age 18 to 70 years.
- •Clinical diagnosis of Tinea pedis and Tinea cruris 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 suffering from onchomycosis, candidiasis, pityriasis versicolor or tinea capitis.
- •Patients with severe chronic diseases.
- •Hypersensitivity to components of Niftifine such as benzyl alcohol,cetyl alcohol ,cetyl esters wax,isopropyl myristate,polysorbat 60,sodium hydroxide,sorbitan monostearate etc.
- •Patients who might have required concomitant medication with other antimycotics administered by another route.
结局指标
主要结局
Itching, Erythema, Scaling/Crusting, Vesicles and papules
时间窗: Day 0, Day 7,Day 14 and Day 28.
次要结局
- Patients and physicians Global Assessment of treatment efficacy and tolerability(Day 28)
- Overall response by mycological assessment (KOH mount)(Day 0 and Day 28)