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CTRI Number  CTRI/2023/02/049755 [Registered on: 15/02/2023] Trial Registered Prospectively
Last Modified On: 31/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Detection of Dermatophytes in Skin and Nails 
Scientific Title of Study   Detection of Dermatophyte in Sub-clinically Involved Nails by PCR in Patients With Skin Dermatophytosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daya Babu 
Designation  Post graduate 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Floor no 5, B block, Department of Dermatology PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore Coimbatore TAMIL NADU 641004 India

Coimbatore
TAMIL NADU
641004
India 
Phone  8075494487  
Fax    
Email  dayababu003@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Daya Babu 
Designation  Post graduate 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Floor no 5, B block, Department of Dermatology PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore Coimbatore TAMIL NADU 641004 India

Coimbatore
TAMIL NADU
641004
India 
Phone  8075494487  
Fax    
Email  dayababu003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Daya Babu 
Designation  Post graduate 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Floor no 5, B block, Department of Dermatology PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore Coimbatore TAMIL NADU 641004 India

Coimbatore
TAMIL NADU
641004
India 
Phone  8075494487  
Fax    
Email  dayababu003@gmail.com  
 
Source of Monetary or Material Support  
PSG Institute of Medical Sciences and Research 
 
Primary Sponsor  
Name  Reena Rai 
Address  Floor no 5, B block, Department of Dermatology PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Reena Rai  PSG Institute of Medical Sciences and Research  Floor no 5, B block, Department of Dermatology PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU 
9894160713

drreena_rai@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee,PSGIMSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L08||Other local infections of skin andsubcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients with skin scrapings showing KOH positive for dermatophytes

Patients who are having a visibly un-affected nail
 
 
ExclusionCriteria 
Details  Patients whose skin scrapings are showing KOH negative for dermatophytes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To detect the presence of Dermatophyte in a clinically unaffected nail by PCR in patients with dermatophytic infection of the skin
 
At first visit 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the type of dermatophyte involved  At first visit 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dermatophytic infection of skin has become an increasing and common problem in population and are found in keratinized layers of skin, nail and hair causing superficial mycoses. Dermatophytic infection of skin is easy to diagnose clinically and microbiological diagnosis is important to confirm the etiology before starting the treatment. Diagnosis can be confirmed by microscopy and culture. Microscopic examination of the skin scrapping and the 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 the organism.  Molecular methods using RTPCR has been developed to overcome this problem. The dermatophyte can rapidly be diagnosed by RT-PCR as they have the advantage of high sensitivity and specificity and faster turnaround time over the other conventional methods and is more accurate for the diagnosis.

 

Patients with extensive dermatophytic infection of the skin can have dermatophytes in the nails due to chronic itching which can be easily missed on clinical examination. These patients may not respond to treatment with conventional dose and duration of antifungals used and they may have 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 often missed.

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

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

 
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