跳至主要内容
临床试验/CTRI/2023/02/049755
CTRI/2023/02/049755尚未招募不适用

Detection of Dermatophyte in Sub-clinically Involved Nails by PCR in Patients With Skin Dermatophytosis

Reena Rai1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年2月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
To detect the presence of Dermatophyte in a clinically unaffected nail by PCR in patients with dermatophytic infection of the skin

研究概览

简要总结

Dermatophytic infection of skin has become anincreasing and common problem in population and are found in keratinized layersof skin, nail and hair causing superficial mycoses. Dermatophytic infection of skinis easy to diagnose clinically and microbiological diagnosis is important toconfirm the etiology before starting the treatment. Diagnosis can be confirmedby microscopy and culture. Microscopic examination of the skin scrapping andthe nail can be performed as an outpatient basis but has low sensitivity. Culture of the fungus takes 4-6 weeks because of the slow growth of theorganism.  Molecular methods using RTPCRhas been developed to overcome this problem. The dermatophyte can rapidly bediagnosed by RT-PCR as they have the advantage of high sensitivity andspecificity and faster turnaround time over the other conventional methods andis more accurate for the diagnosis.

 Patients with extensive dermatophytic infection of theskin can have dermatophytes in the nails due to chronic itching which can beeasily missed on clinical examination. These patients may not respond totreatment with conventional dose and duration of antifungals used and they mayhave periodic recurrences.

 In such patients, microscopy with potassium hydroxide(KOH) and culture may not reveal the dermatophytes due to poor sensitivity,specificity and so, the detection of the dermatophytes in the nails are oftenmissed.

In such patients, PCR being more sensitive andspecific can be a better technique to detect the fungus in the nail.

So, we plan to conduct a study to detect dermatophytesin patients with uninvolved nails by PCR in people who are having KOH-positiveskin dermatophyte infection.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients with skin scrapings showing KOH positive for dermatophytes Patients who are having a visibly un-affected nail.

排除标准

  • Patients whose skin scrapings are showing KOH negative for dermatophytes.

结局指标

主要结局

To detect the presence of Dermatophyte in a clinically unaffected nail by PCR in patients with dermatophytic infection of the skin

时间窗: At first visit

次要结局

  • To identify the type of dermatophyte involved(At first visit)

研究者

发起方
Reena Rai
申办方类型
Other [self]

研究点 (1)

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