FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096392 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to observe nail changes using a special magnifying light in patients with fungal nail infection 
Scientific Title of Study   Onychoscopic Insights into Onychomycosis: A Cross-Sectional Study of Pattern and Clinical Subtype Association 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASHITA NALLAPATI 
Designation  Postgraduate Resident 
Affiliation  JSS Medical College And Hospital, Mysore 
Address  1011-1017, Dermatology Department, JSS Hospital ,Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004 9148863950

Mysore
KARNATAKA
570004
India 
Phone  9148863950  
Fax    
Email  ashita2468@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ASHWINI PK 
Designation  Associate Professor  
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE 
Address  1011-1017, Dermatology Department, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004 9148863950

Mysore
KARNATAKA
570004
India 
Phone  9886379361  
Fax    
Email  ashwinipk@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  ASHITA NALLAPATI 
Designation  Postgraduate Resident 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE 
Address  1011-1017, Dermatology Department,JSS Hospital, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004 9148863950

Mysore
KARNATAKA
570004
India 
Phone  9148863950  
Fax    
Email  ashita2468@gmail.com  
 
Source of Monetary or Material Support  
INDIAN ASSOCIATION OF DERMATOLOGISTS VENEROLOGISTS AND LEPROLOGISTS 314-315, 3rd Floor KM Trade Tower, H 3, Sector 14, Kaushambi, Ghaziabad, Uttar Pradesh, India, 201010 
 
Primary Sponsor  
Name  Ashita Nallapati  
Address  Dermatology Department,JSS Hospital, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka, 570004 
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 
Ashita Nallapati   JSS HOSPITAL, MYSURU   1011-1017, Dermatology Department, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka, 570004
Mysore
KARNATAKA 		 9148863950

ashita2468@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE, JSSMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B351||Tinea unguium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Consenting patients older than 18 years of age and all sexes, clinically diagnosed to have new onset and treatment naïve onychomycosis with confirmation either with KOH or with fungal culture will be recruited 
 
ExclusionCriteria 
Details  o Patient who had applied topical anti-fungal therapy in the past 1 month
o Patients using oral anti/fungal therapy in past 3 months
o Patients with other nail pathologies affecting the nails such as nail psoriasis, trauma, lichen planus
o Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the onychoscopic patterns observed in onychomycosis  10 months  
 
Secondary Outcome  
Outcome  TimePoints 
To explore the association of the observed onychoscopic patterns with clinical subtypes of onychomycosis  2 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/11/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Onychoscopy is dermoscopic examination of the nail apparatus, which includes the nail plate surface and the free edge, nail matrix, nail bed, periungual folds, and hyponychium. It forms a link between naked eye examination and nail histopathology, opening the potential to prevent biopsy  Dermoscopic technique, has demonstrated potential in improving diagnostic accuracy by visualizing distinct morphological signs of fungal nail infections.

However, there’s limited data, particularly in Indian populations, on its diagnostic utility across various clinical subtypes of onychomycosis.

Hence the primary objective of the study includes documenting the onychoscopic patterns observed in onychomycosis.

While the secondary objective aims to explore the association of these dermoscopic patterns with the clinical subtypes of onychomycosis.

 

This study is justified by the clinical need for a rapid, reliable, and accessible diagnostic adjunct to improve the identification of onychomycosis, particularly in contexts where traditional diagnostic tools are unavailable, unaffordable, or delayed

 


 
Close