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CTRI Number  CTRI/2020/03/023959 [Registered on: 13/03/2020] Trial Registered Prospectively
Last Modified On: 12/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinicomycological study and efficacy of antifungal treatment in dernatophytosis. 
Scientific Title of Study   Clinicomycological Study and Efficacy of Antifungal treatment in patients of Dermatophytosis in Department of Dermatology, GMERS Medical College And General Hospital, Gotri , Vadodara.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Grishma kanak fumtiwala 
Designation  dermatology resident 
Affiliation  GMERS medical college and hospital,gotri,vadodara 
Address  Opd 205, GMERS Medical College And Hospital,Gotri, Vadodara
Room 304 , Resident Hostel, GMERS Medical College And Hospital, Gotri, Vadodara
Vadodara
GUJARAT
392001
India 
Phone  8128281353  
Fax    
Email  grishmafumtiwala13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raksha patel 
Designation  Professor And Head Of Department 
Affiliation  GMERS medical college and hospital,gotri,vadodara 
Address  OPD 205, GMERS Medical College And Hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  09426570097  
Fax    
Email  rakshamp@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Grishma kanak fumtiwala 
Designation  dermatology resident 
Affiliation  GMERS medical college and hospital,gotri,vadodara 
Address  Opd 205,GMERS Medical College And Hospital , Gotri, Vadodara 390021

Vadodara
GUJARAT
390021
India 
Phone  8128281353  
Fax    
Email  grishmafumtiwala13@gmail.com  
 
Source of Monetary or Material Support  
Gmers gotri medical hospital vadodara 
 
Primary Sponsor  
Name  GMERS Medical College And Hospital Gotri 
Address  Opd 205, GMERS Medical College And Hospital , Gotri, Vadodara 
Type of Sponsor  Government 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 
Grishma fumtiwala  Gmers medical college and hospital   Opd 205 ,gmers medical college and hospital gotri, vadodara
Vadodara
GUJARAT 
8128281353

grishmafumtiwala13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinicomycological Study And Efficacy Of Antifungals Terbinafene, Fluconazole And Itraconazole In Treatment Of Dermatophytosis  compare efficacy of antifungals Terbinafene, Fluconazole And Itraconazole in Treatment Of Dermatophytosis 
Intervention  Efficacy of antifungal treatment in detmatophytosis  efficacy of terbinafene, fluconazole and itraconazole in treatment of dermatophytosis. Tablet Fluconazole (150mg) Twice weekly for 15 days Tablet Terbinafene (500mg) 1 od for 15 days Tablet Itraconazole (200mg) 1 od for 15 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex
Patients 18 years or above
Patient is suffering from dermatophyte infection diagnosed clinically
Patient is suffering from dermatophyte infection in body and genitals
Patients with scaling present on lesion
Ability to give oral informed consent

 
 
ExclusionCriteria 
Details  Patient has been treated with oral or topical antifungal agents in last 3 months
Patient on steroid therapy
Patient having H/o hypersensitivity to above mentioned drugs
Pregnancy or lactating mother
Patient having any abnormal CVS, Renal , Hepatic functions or uncontrolled Diabetes Mellitus or HIV
Patient who can’t come for regular follow up

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
ClinicalAnd Statistical Cure in pruritus, erythema and scaling score
Improvement in Global Assessment scale Mycological cure by studying KOH

 
ClinicalAnd Statistical Cure in pruritus, erythema and scaling score
Improvement in Global Assessment scale
Mycological cure by studying KOH
Outcome will be assessed after 1 year at the end of study

Patient will be follwed up after 15 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in global assessment score and mycological cure in koh  improvement in global assessment score and mycological cure in koh

Outcome will be asssessed after 1 year at the end of study.
Patient will be followed up at interval of 15 days. 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   14/03/2020 
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="0"
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)?  

Brief Summary  

Superficial fungal infection due to dermatophytosis is one of the most common skin infections in the India.It is contagious. The dermatophytes are a group of fungi that invade the superficial layer of epidermis and degrade the keratinized tissues of skin, hair and nails in living animals including man, causing ring worm. (1)(2) But in rare cases they invade the deeper layer of the dermis and other organs. A dermatophyte infection results in increased skin proliferation, scaling, and epidermal thickening.

Dermatophytosis is the fungal infection of keratinized tissue. It is caused by three asexual genera- Trichophyton, Epidermophyton, and Microsporum. Dermatophytes are filamentous, keratinophilic, pathogenic fungi which are readily identified by microscopic examination of clinical specimen and can be cultured easily in laboratory. Depending on their habitat, they can be categorized as geophilic, zoophilic and anthropophilic.Based upon the affected site, these have been classified clinically into tinea capitis (head), tinea facei (face), tinea barbae (beard), tinea corporis (body), tinea mannum (hand), tinea cruris (groin), tinea pedis (foot), and tinea unguium (nail).

Fluconazole, terbinafine, itraconazole are commonly used antifungal agent in dermatophytosis. Resistance to these drugs is being seen increasingly when used in conventional doses and duration.

 

 
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