A Prospective , Randomized , Open Label Study To Evaluate The Efficacy And Safety Of Systemic Terbinafine And Topical Amorolfine Compared to Systemic Itraconazole And Topical Amorolfine In Adult Patients Of Recalcitrant Tinea Cruris
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare safety and efficacy of Itraconazole and Terbinafine in achieving complete cure in recalcitrant tinea cruris infections by 4 point rating scale
研究概览
简要总结
Dermatophytosis is infection of skin or its derivatives,caused by fungi,known as dermatophytes,leading to erythema,papules,plaques,vesicles, fissures and scaling formation. Dermatophytes, most commonly are caused by Trichophyton species. Most common manifestation in humans is Tinea corporis and Tinea cruris. Recalcitrant Tinea includes relapse, recurrence , re-infection , persistence of infection and chronic tinea cases. this study will be prospective , open label , randomized , parallel, in patients of recalcitrant tinea cruris.
Primary objective of the study is to, observe the relative effects of systemic Itraconazole and Terbinafine combined with a common topical agent Amorolfine cream 0.25%, in improvement of clinical profile of patients based on clinical and microbiological assessment.
Patients will be divided randomly in 2 groups, A and B comprising of 50 patients each.
Group A will receive Itraconazole 100 mg BD daily and topical Amorolfine 0.25% BD daily for local application.
Group B will receive Terbinafine 250 mg Od daily and topical Amorolfine 0.25% BD daily for local application.
Treatment will be continued for 8 weeks and response will be assessed based on 4 point rating scale. Patients will be evaluated at 2,4,6,8 weeks for the treatment response.
Post treatment follow up will be done at 10 and 12 weeks from the start of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with recalcitrant Tinea Cruris
- •Patients willing to give informed consent and comply with the treatment and follow up.
排除标准
- •<18 years and > 65 years age
- •Pregnant or Lactating women
- •Secondary bacterial infections
- •Deep mycosis
- •Immunocompromised patients- Severe uncontrolled Diabetes, HIV/AIDS, chronic glucocorticoid therapy
- •Patients with abnormal liver function and kidney function test
- •Present or past history of malignancy
- •Patients with known history of allergy to Itraconazole or Terbinafine or related drugs
- •patients with history of ischemic heart disease
- •Patients not giving informed consent.
结局指标
主要结局
To compare safety and efficacy of Itraconazole and Terbinafine in achieving complete cure in recalcitrant tinea cruris infections by 4 point rating scale
时间窗: 2,4,6,8,10,12 weeks
次要结局
- Compare adverse effect profile of Itraconazole and Terbinafine(2,4,6,8,10,12 weeks)
- To assess the non-responders, if any(12 weeks)