A clinico-epidemiological, microbiological, histopathological and therapeutic study of recurrent dermatophytosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 3. Therapeutic efficacy of single and combinations of systemic antifungal drugs in recurrent dermatophytic infections will be reported.
研究概览
简要总结
This study is a randomised, double blind, parallel group, multi arm trial comparing the therapeutic efficacy of various systemic anti fungal drugs in recurrent dermatophytic infections. A detailed history including the previous treatment history will be taken and clinical examination will be done. In all suspected cases of recurrent dermatophytic infections, specimens will be collected by scraping the active edge of the affected skin and will be subjected to direct microscopic examination using 10%KOH. A part of the collected specimen will also be sent for fungal culture in sterile specimen bottle.Sabourads dextrose agar slopes will be used for primary isolation and Dermatophyte test medium will be used as selective medium. Species identification will be done by colony morphology and microscopy on Lactophenol cotton blue mount. Skin biopsy from affected site will be done and sent for histopathological examination. In GMS and PAS stain specimens, the presence of fungal hypae in all layers of epidermis, hair follicle and other structures will be studied. All subjects will be divided into 6 groups of 30 each by randomisation using computer based softwares and are given systemic antifungals to know the therapeutic efficacy after 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of recurrent dermatophytoses infection with at least one episode of relapse with 4Â weeks of completing the recommended duration of anti fungal therapy.
- •Both sexes between the age groups 18.
排除标准
- •Infants, patients below 18 years and above 70 years
- •Immunocompromised patients (HIV).
- •Pregnant and lactating females.
- •Patients receiving multiple drugs (glucocorticoids, statins, etc.) for other medical conditions.
结局指标
主要结局
3. Therapeutic efficacy of single and combinations of systemic antifungal drugs in recurrent dermatophytic infections will be reported.
时间窗: 8 weeks
1. Clinical profile of recurrent dermatophytic infections prevalent in this region will be recorded.
时间窗: 8 weeks
2. The mycological profile and histopathological profile in recurrent dermatophytosis will be recorded.
时间窗: 8 weeks
次要结局
- 1. To note recurrences in the follow up period of 3 months(3 months)