CTRI/2021/01/030753尚未招募3 期
A Phase III, Multi-Center, Double Blind, Comparative, Randomised, Prospective,Parallel Study to evaluate the Efficacy and Safety Naftifine Hydrochloride Gel 2% in patients with Interdigital Tinea Pedis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 8
- 主要终点
- Proportion of patients achieving clinical cure
研究概览
简要总结
This is a phase III, double blind, two-arm, randomized, prospective, multi center, efficacy and safety study of Naftifine Hydrochloride Gel 2%, in patients with Interdigital Tinea Pedis. The randomization would be in 1:1 ratio between Naftifine Hydrochloride Gel 2% and Miconazole Gel 2% arms respectively. The primary objective is to evaluate the efficacy of Naftifine Hydrochloride Gel 2% in patients with Interdigital Tinea Pedis and secondary objective is To evaluate the safety and tolerability of Naftifine Hydrochloride Gel 2% in patients with Interdigital Tinea Pedis. The total study duration for each patient would be 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females 18-65 years of age
- •Patients with clinical diagnosis of tinea pedis
- •Patients with the sum of the clinical signs and symptoms scores of the target lesion is at least 5(on a scale of 0-3)
- •Patients with mycological diagnosis of interdigital tinea pedis.
排除标准
- •Patients 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
- •Patients with known hypersensitivity to Naftifine and/or to any component of the formulation
- •Patients who are immunocompromised (due to disease (HIV or medications)
- •Patients with uncontrolled diabetes mellitus (HbA1C ≥8) at study entry
- •Patients using the following medications:.
- •Use of antipruritics, including antihistamines, within 72hours prior to randomization.
- •Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to randomization.
- •Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to randomization.
- •Use of oral terbinafine or itraconazole within 2 months prior to randomization.
- •Use of immunosuppressive medication or radiation therapy within 3 months prior to randomization.
结局指标
主要结局
Proportion of patients achieving clinical cure
时间窗: Week 6 (± 4 days) (study day 38-46) following 2 weeks of treatment
次要结局
- Proportion of patients achieving clinical cure(Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment)
- Proportion of patients achieving mycological cure(Week 6 (± 4 days) (study Day 38-46) and at Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment)
- Proportion of patients achieving complete clearance(Week 6 (± 4 days) (study day 38-46) and at Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment)
- Treatment emergent clinical & laboratory adverse events (TEAEs)(All Visits)
研究者
研究点 (8)
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