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CTRI Number  CTRI/2023/07/054989 [Registered on: 10/07/2023] Trial Registered Prospectively
Last Modified On: 09/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Validation Of Dermatphytosis Severity Score And Its Correlation With Patient Reported Outcome Measures 
Scientific Title of Study   Clinico-Mycological Validation Of Dermatophytosis Severity Score And Its Correlation With Patient Reported Outcome Measures 
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 Ramesh Bhat M 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of Dermatology, Father Muller Medical college, Kankanady,Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845084224  
Fax    
Email  rameshderma@fathermuller.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Bhat M 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of Dermatology, Father Muller Medical college, Kankanady,Mangalore


KARNATAKA
575002
India 
Phone  9845084224  
Fax    
Email  rameshderma@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ramesh Bhat M 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of Dermatology, Father Muller Medical college, Kankanady,Mangalore


KARNATAKA
575002
India 
Phone  9845084224  
Fax    
Email  rameshderma@fathermuller.in  
 
Source of Monetary or Material Support  
Father muller research centre, Kankanady, Mangalore 
 
Primary Sponsor  
Name  Father muller research centre 
Address  Father Muller Medical college, Kankanady,Mangalore  
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 
Dr Jiby V Benny  Father muller medical college  Dermatology OPD,Father Muller Medical College, Kankanady,Mangalore
Dakshina Kannada
KARNATAKA 
9535435170

jibybenny@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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  (i) Aged 18 years and above
(ii) Clinically diagnosed cases of dermatophytosis involving the non glabrous skin 
 
ExclusionCriteria 
Details  i)Patients aged below 18 years
(ii) Patients with dermatophytosis with exclusive scalp, nail, palms, or soles
(glabrous skin )involvement.
(iii) Patients with other co-existing papulo-squamous dermatoses involving
the same areas in addition to dermatophytosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Dermatophyte severity score  at baseline , 4weeks , 8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   17/07/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Dermatophytosis is a widespread superficial skin mycosis known to affect more than 20%–25% 
of the human population. In recent years there has been a drastic shift in the disease 
presentation, severity, treatment response, and rate of relapse.The increasing occurrence of 
drug resistance is influenced by a multitude of factors ranging from delayed, inappropriate and 
inadequate treatment to mutant fungal species. There is an epidemic rise of chronic and 
recurrent dermatophytosis both globally and in India.Some patients with acute superficial 
dermatophytosis are able to effectively clear the fungi, leading to resolution of the infection. 
However, others who suffer from chronic and recurrent dermatophytoses are unable to develop 
this response 4.
Bhat et al developed and validated an objective scoring tool for dermatophytosis through the 
dermatophytosis severity score (DSS) . The score assesses and combines various factors that 
determine the severity and outcomes of dermatophytosis thereby creating an accurate and 
reproducible severity scale. This new classification system is an important tool for clinicians since 
the score can serve as a guide to treatment choice, and for the prediction of response to treatment.
However, there is a need to evaluate the variation of DSS with treatment and to assess whether it 
reflects the changing course of illness. Patient-reported outcomes (PROs) are effective tools to 
better understand a patient’s health condition, goals, and unique factors related to their care 
When implementing an effective patient-centered care strategy it is vital for providers to track 
PRO scores over time. There is an increasing emphasis both in dermatology and medicine to 
adequately capture the patient The score needs to be corroborated with both clinical and 
mycological parameters to assess its responsiveness to the change in the clinical status of the 
patient and the mycological status of dermatophytosis. 
The present study seeks to compare the DSS with the clinical status of the patient both 
objectively as well as with the PRO scores.
IMPLICATIONS OF THE STUDY
Dermatophytosis has assumed epidemic proportions in India and furthermore, continues to be 
ever increasing in its severity, resistance to treatment and relapse rate. This pilot study seeks to 
validate DSS to determine its correlation with the clinical status of the patient, mycological response and PRO scores. The additional utility would be ease of communicating the findings 
across a global platform would be greatly aided by validating the DSS in clinical settings and 
observing its variation during the course of treatment.
Thus, it is of relevance to validate the scoring tool at point of care settings so as to document 
disease severity and accordingly plan the treatment choice. Future studies can aid in assessing the 
accuracy and reproducibility of the scale at different centres to improve its applicability.
 
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