Comparative efficacy of oral Itraconazole alone and in combination with low dose and high dose Isotretinoin in the treatment of dermatophytosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Compare the therapeutic efficacy of concomitant use of low and high dose isotretinoin along with itraconazole in dermatophytosis
研究概览
简要总结
Dermatophytosis is caused by mainly Trichophyton , Epidermophyton and MIcrosporum affecting more than 20- 25% of world’s population. Recently there has been an alarming rise in the number of dermatophytosis patients as well as the recalcitrant cases .
The recent change in the dermatophyte infection has resulted in a change in its response to treatment as well. The conventional systemic agents like griseofulvin , ketoconazole , fluconazole and even the newer synthetic agents like itraconazole , terbinafine are no longer effective as they were initially .
The present study is being designed to assess the role of isotretinoin in low and high dose as an adjuvant along with oral itraconazole in treatment of dermatophytosis. It aims to find whether patients treated with this combination have better efficacy and less treatment failures .
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •KOH positivity on direct microscopy showing septate hyphae of dermAtophytosis .
- •Patients with extensive disease requiring systemic therapy .
- •Patients above 18 years of age .
排除标准
- •Patients with co-existing dermatophytosis involving hairs, nail, palms and soles.
- •Patients with hepatic , renal derangement , abnormal lipidvprofile or any significant systemic illness.
- •Patients on immunosuppressive agents.
- •Pregnant and lactating women .
- •Women of child bearing age not using contraception indicated for systemic retinoids therapy .
结局指标
主要结局
Compare the therapeutic efficacy of concomitant use of low and high dose isotretinoin along with itraconazole in dermatophytosis
时间窗: 0,2,4,8 weeks
次要结局
- To look for adverse effects of combination of Itraconazole and Isotretinoin(0,2,4,8 weeks)