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CTRI Number  CTRI/2024/12/078184 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Identifying the Visible Signs of Different Ringworm Infections and Their Fungal Causes 
Scientific Title of Study   Delineation of Morphological Features of Different Clinical Types of tinea (Dermatophytosis) with Specific Dermatophyte Species 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesha Bhat M 
Designation  Professor and Unit Head, Department of Dermatology 
Affiliation  Father Muller Medical College Hospital 
Address  Father Muller Medical College Hospital, Father Muller Road, Kankanady, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  919845084224  
Fax    
Email  rameshderma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesha Bhat M 
Designation  Professor and Unit Head, Department of Dermatology 
Affiliation  Father Muller Medical College Hospital 
Address  Father Muller Medical College Hospital, Father Muller Road, Kankanady, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  919845084224  
Fax    
Email  rameshderma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesha Bhat M 
Designation  Professor and Unit Head, Department of Dermatology 
Affiliation  Father Muller Medical College Hospital 
Address  Father Muller Medical College Hospital, Father Muller Road, Kankanady, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  919845084224  
Fax    
Email  rameshderma@gmail.com  
 
Source of Monetary or Material Support  
FMRC Grant Father Muller Research Centre Unit of Father Muller Charitable Institutions Kankanady Mangalore Karnataka India 575002 
 
Primary Sponsor  
Name  FMRC Grant 
Address  Father Muller Research Centre, Unit of Father Muller Charitable Institutions, Kankanady, Mangalore, Karnataka, India - 575002 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Ramesha Bhat M  Father Muller Medical College Hospital  Room No 65 Out Patient Department of Dermatology Father Muller Medical College Hospital Father Muller Road Kankanady Mangalore Karnataka India 575002
Dakshina Kannada
KARNATAKA 		 9845084224

rameshderma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional 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, (2) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, (3) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients of all age groups diagnosed with various types of dermatophytes, confirmed through clinical examination and potassium hydroxide (KOH) microscopy. 
 
ExclusionCriteria 
Details  Patients with exclusive onychomycosis, Tinea capitis or those currently on antifungal treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identification of distinct morphological features associated with specific species of Trichophyton, Epidermophyton, and Microsporum and respective subspecies like T. Mentagrophytes type VIII(indotineae) with the help of culture and MALDI-TOF.

Development of a diagnostic algorithm or set of criteria to aid in the identification of the causative species based on clinical presentation.

 		 The aims of this research project will be evaluated in parallel during the period of one year of the study. Periodic assessments will monitor any developments and assure that they conform to the primary research objectives. 
 
Secondary Outcome  
Outcome  TimePoints 
The study is anticipated to establish a significant clinico-mycological correlation using the Dermatophyte Severity Score (DSS), allowing for more accurate assessment of the severity and specific dermatophyte species involved in dermatophytosis.
Enhanced understanding of the pathophysiology of different types of tinea, leading to improved diagnostic and treatment strategies.
 		 The aims of this research project will be evaluated in parallel during the period of one year of the study. Periodic assessments will monitor any developments and assure that they conform to the secondary research objectives. 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   16/12/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a primary research study not a clinical trial and proposes a solution to the problem of the diagnosis of dermatophyte genus organisms from clinical samples. The study aims to enhance the precision of clinical diagnostics by associating certain morphological characteristics with dermatophyte species in order to provide effective treatment options. The results can lessen the dependence on long and costly lab tests, promoting quicker, more efficient treatment of dermatophytosis. The sample collection for the study has not yet been started. 
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