Comparing the therapeutic efficacy of oral Itraconazole with topical Ketoconazole vs oral Terbinafine with topical Ketoconazole in treatment of Dermatophytosis: A randomized control trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patients overall satisfaction from
研究概览
简要总结
· Dermatophytic infections are the most common fungal infections affecting 20%–25% population globally.
· It is caused by all species of dermatophytes like Microsporum,Trichophyton and Epidermophyton which colonises the keratinized tissue using keratin as nutrition.
· Terbinafine is considered to be a first-line drug for the treatment of tinea corporis and tinea cruris due to its favorable mycological and pharmacokinetic profile.
· It acts by inhibiting the enzyme squalene epoxidase, thereby inhibiting ergosterol synthesis. Recently, there has been an increase in the incidence of terbinafine resistance with increasing numbers of clinical failures and relapses
· One of the principal mechanisms of antifungal resistance is decrease in effective drug concentration.
· It has been observed recently that there has been widespread resistance to various antifungal agents used in conventional dose with an increase in relapse rates prompting a need to find an effective first-line antifungal drug and appropriate dosage and duration schedule and topical agent to achieve maximum results with fewer relapses.
· Hence, the present study was conducted to compare the efficacy of oral terbinafine with ketoconazole versus itraconazole with ketoconazole in the treatment of tinea corporis and tinea cruris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with diagnosis of tinea corporis and tinea cruris confirmed by KOH microscopy.
- •Patients for whom documented consent has been obtained regarding their voluntary participation in this clinical study.
- •Patients aged 18 years or older at the time that they provide consent.
- •Patient agrees not to take other treatments than those provided in the study.
排除标准
- •Patient below 18 years of age.
- •Pregnant and lactating mothers.
- •Patient who are immunocompromised due to disease or drugs.
- •Patient with pre existing renal,hepatic diseases and cardiac failure.
- •Patient with history of hypersensitivity to itraconazole, terbinafine and ketoconazole.
结局指标
主要结局
Patients overall satisfaction from
时间窗: baseline and at 4 weeks
the condition
时间窗: baseline and at 4 weeks
次要结局
未报告次要终点