A prospective clinical study to explore the oral Fluconazole resistance in Tinea Corporis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Clinical cure of Pruritus,Erythema and Scaling
研究概览
简要总结
Introduction:
Dermatophytes are superficial fungal infections that invade and multiply within the keratinised tissues such as skin, hair , nails.worlwide infection with dermatophytes accounts for approximately 25% of infective skin disease. Fluconazole is the the first line treatment of choice for tinea corporis . This study aimed to evaluate the Fluconazole resistance in Tinea corporis and to corelate the peak plasma concentration of Fluconazole and Tinea corporis resistance.
Materials and Methodology:
sample size of 94 Tinea corporis patients will be recruited to treat with Fluconazole for a period of 15 days .patients will be reviewed at the end of 15 days . If there is a clinical cure and they will be declared as cured andv responded to Fluconazole. If there is no clinical cure and not responded to Fluconazole on 15 th day , peak plasma concentratioin of Fluconazole will be measured using HPLC and skin scraping for fungal culture will be done.
Result:
Data collection will be statistically analysed by pearson corelation.
Conclusion:
IHEC approval:
This study has been approved by the IHEC of PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH ( affiliated to TN MGR Medical University ), coimbatore
Proposal number- 19/330 dt.21.01.2020
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Single or multiple annular erythematous plaques 2.KOH mount positive for Tinea corporis 3.No previpous exposure to Fluconazole 4.Comorbidities like Diabetes mellitus, obesity and other endocrine disorders.
排除标准
- •1.Large cofluent lesions.
- •2.History of previous exposure to Fluconazole 3.Patients on medications like steroide, antihistamines, aspirin, immunomodulators,statins,NSAIDS.
- •4.Patients on chronic medications for TB, HIV, Leprosy.
结局指标
主要结局
Clinical cure of Pruritus,Erythema and Scaling
时间窗: At 15th day of Fluconazole Treatment
次要结局
- To assess the resistance of Fluconazole in patients with comorbidities like Diabetes mellitus, obesity and other endocrine disorders(At 15th day of Fluconazole treatment)
- To study the role of plasma levels of Fluconazole if there is a resistance and no clinical cure with Fluconazole(HPLC - analysis of Fluconazole levels, skin scrapings-culture)
- To observe the side effects of Fluconazole following administration of Fluconazole(During the 15 days of Fluconazole therapy)