Efficacy and Safety of the Topical Naftifine 2% Therapy versus Topical Luliconazole 1% Therapy in Patients with Localized Tinea Corporis in a Tertiary Care Centre
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome was to determine the efficacy and safety of two topical {naftifine, luliconazole} therapies in terms of a number of patients achieving complete clearance.
研究概览
简要总结
A total of 60 patients with Localized Tinea Corporis in a tertiary care centre each arm comprising of 30 patients will be recruited based on clinical and mycological reports after getting CTRI registration number.
the patients are given treatment after proper informed consent for about 6 weeks by recording improvements every 2 weeks and then follow up done every 2 weeks for about 6 weeks. Total duration of the study will be 6 months. in case of emergency or adverse reactions following treatment they will be treated accordingly ater given information to IEC committee. The improvement of symptoms will be noted and statistical analysis will be done accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients above the age of 18 years of either sex who were clinically and mycologically diagnosed of a case of localized dermatophytosis were included in the study.
排除标准
- •Patients with extensive dermatophytosis, other forms of tinea infections Superadded bacterial infection Immunocompromised patients Dermatitis such as contact dermatitis, atopic dermatitis, psoriasis, other skin diseases Use of corticosteroids in the last 4 weeks.
- •Pregnant and lactating mothers Patients with a history of hypersensitivity to azole antifungals Patients who received topical antifungal within 1 week before baseline visit and patients who received systemic antifungals within 4 weeks before baseline were excluded from the study.
结局指标
主要结局
The primary outcome was to determine the efficacy and safety of two topical {naftifine, luliconazole} therapies in terms of a number of patients achieving complete clearance.
时间窗: The primary outcome was to determine the efficacy and safety of two topical {naftifine, luliconazole} therapies in terms of a number of patients achieving complete clearance at 2 weeks, 4 weeks, 6 weeks , 8 weeks
次要结局
- The secondary outcome was to determine the safety of two topical {naftifine, luliconazole} therapies in terms of number of patients achieving complete clearance.(The secondary outcome was to determine the safety of two topical {naftifine, luliconazole} therapies in terms of number of patients achieving complete clearance at 2 weeks, 4 weeks, 6 weeks & 8 weeks)
研究者
DR R SUGANYA
KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE