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CTRI Number  CTRI/2023/11/059827 [Registered on: 14/11/2023] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two anti-fungal drug combination in the treatment of fungal infection. 
Scientific Title of Study   Comparing the therapeutic efficacy of oral Itraconazole with topical Ketoconazole vs oral Terbinafine with topical Ketoconazole in treatment of Dermatophytosis: A randomized control trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Raj 
Designation  Junior Resident 
Affiliation  Meenakshi Medical College 
Address  Meenakshi Medical College Hospital and Research Institute

Kancheepuram
TAMIL NADU
631552
India 
Phone  8973378778  
Fax    
Email  Deepakhbk44444@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kumaravel S 
Designation  Professor and Head 
Affiliation  Meenakshi Medical College 
Address  Meenakshi Medical College Hospital and Research Institute

Kancheepuram
TAMIL NADU
631552
India 
Phone  9884646324  
Fax    
Email  kumaravel1959@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kumaravel S 
Designation  Professor and Head 
Affiliation  Meenakshi Medical College 
Address  Meenakshi Medical College Hospital and Research Institute


TAMIL NADU
631552
India 
Phone  9884646324  
Fax    
Email  kumaravel1959@gmail.com  
 
Source of Monetary or Material Support  
Meenakshi medical college hospital and research institute 
 
Primary Sponsor  
Name  meenakshi medical college hospital and research institute 
Address  Enathur,karrapettai post,kanchipuram-631552 
Type of Sponsor  Private medical college 
 
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 
Deepak Raj  Meenakshi Medical College Hospital and research institute  Department of D.V.L.,Room no:45,Enathur,karrapettai post,kanchipuram-631552
Kancheepuram
TAMIL NADU 		 8973378778

Deepakhbk44444@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Meenakshi Medical College Hospital and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Itraconazole and Ketoconazole  Oral Itraconazole 200mg od. Topical Ketoconazole 2% bd. 
Comparator Agent  Terbinafine and Ketoconazole  Oral Terbinafine 250mg od. Topical Ketoconazole 2% bd. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Patient with diagnosis of tinea corporis and tinea cruris confirmed by KOH microscopy.

2)Patients for whom documented consent has been obtained regarding their voluntary participation in this clinical study.

3)Patients aged 18 years or older at the time that they provide consent.

4)Patient agrees not to take other treatments than those provided in the study.
 
 
ExclusionCriteria 
Details  1)Patient below 18 years of age.

2)Pregnant and lactating mothers.

3)Patient who are immunocompromised due to disease or drugs.

4)Patient with pre existing renal,hepatic diseases and cardiac failure.

5)Patient with history of hypersensitivity to itraconazole, terbinafine and ketoconazole
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients overall satisfaction from
the condition
 		 baseline and at 4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/11/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/04/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·       Dermatophytic infections are the most common fungal infections affecting 20%–25% population globally.

·       It is caused by all species of dermatophytes like Microsporum,Trichophyton and Epidermophyton which colonises the keratinized tissue using keratin as nutrition. 

·       Terbinafine is considered to be a first-line drug for the treatment of tinea corporis and tinea cruris due to its favorable mycological and pharmacokinetic profile.

·       It acts by inhibiting the enzyme squalene epoxidase, thereby inhibiting ergosterol synthesis. Recently, there has been an increase in the incidence of terbinafine resistance with increasing numbers of clinical failures and relapses 

·       One of the principal mechanisms of antifungal resistance is decrease in effective drug concentration.

·        It has been observed recently that there has been widespread resistance to various antifungal agents used in conventional dose with an increase in relapse rates prompting a need to find an effective first-line antifungal drug and appropriate dosage and duration schedule and topical agent to achieve maximum results with fewer relapses.

·       Hence, the present study was conducted to compare the efficacy of oral terbinafine with ketoconazole versus itraconazole with ketoconazole in the treatment of tinea corporis and tinea cruris.

 
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