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CTRI Number  CTRI/2025/10/096388 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Mobile application for the detection of leprosy in Indian skin 
Scientific Title of Study   Development, validation and pilot study of a deep learning based artificial intelligence (AI) model for early detection of leprosy in Indian skin- a mobile application based approach for primary healthcare workers 
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 S Chidambara Murthy 
Designation  Professor and HOD 
Affiliation  Ballari Medical College and Research Centre, Ballari (formerly VIMS) 
Address  Department of DVL, Ballari Medical College and Research Centre, Ballari, Karnataka

Bellary
KARNATAKA
583104
India 
Phone  9845784969  
Fax    
Email  chidumurthy@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Chidambara Murthy 
Designation  Professor and HOD 
Affiliation  Ballari Medical College and Research Centre, Ballari (formerly VIMS) 
Address  Department of DVL, Ballari Medical College and Research Centre, Ballari, Karnataka

Bellary
KARNATAKA
583104
India 
Phone  9845784969  
Fax    
Email  chidumurthy@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Chidambara Murthy 
Designation  Professor and HOD 
Affiliation  Ballari Medical College and Research Centre, Ballari (formerly VIMS) 
Address  Department of DVL, Ballari Medical College and Research Centre, Ballari, Karnataka

Bellary
KARNATAKA
583104
India 
Phone  9845784969  
Fax    
Email  chidumurthy@rediffmail.com  
 
Source of Monetary or Material Support  
Research grant from Indian Association of Dermatologists, Venereologists and Leprologists 314-315, 3rd Floor KM Trade Tower, H 3, Sector 14, Kaushambi, Ghaziabad, Uttar Pradesh, 201010 
 
Primary Sponsor  
Name  Indian Association of Dermatologists, Venereologists and Leprologists 
Address  314-315, 3 rd floor KM trade tower, H 3 sector 14, Kaushambi, Ghaziabad, Uttar Pradesh, 201010 
Type of Sponsor  Other [National specialty organization] 
 
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 S Chidambara Murthy  Ballari Medical College and Research Centre, Ballari  Room number 65 Department of DVL Ballari Medical College and Research Centre, Vijaya Nagar, Cantonment, Ballari, Karnataka 583104
Bellary
KARNATAKA 
9845784969

chidumurthy@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Ballari medical college and research centre, Ballari  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A300||Indeterminate leprosy, (2) ICD-10 Condition: A301||Tuberculoid leprosy, (3) ICD-10 Condition: A302||Borderline tuberculoid leprosy, (4) ICD-10 Condition: A303||Borderline leprosy, (5) ICD-10 Condition: A304||Borderline lepromatous leprosy, (6) ICD-10 Condition: A305||Lepromatous leprosy, (7) ICD-10 Condition: A308||Other forms of leprosy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients of all ages and genders with diverse types of leprosy such as the indeterminate, tuberculoid, borderline tuberculoid, borderline boderline, lepromatous leprosy and lepra reactions- type 1 and 2.
2. Patients consenting to participate in the study. 
 
ExclusionCriteria 
Details  1. Patients who were treated for leprosy with anti-leprosy drugs for more than 3 months.
2. Patients with pure neuritic leprosy and diffuse infiltration of LL leprosy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know whether the AI deep learning model achieves a minimum performance of more than 70 percent accuracy and area under ROC validate its feasibility for early detection of leprosy in Indian skin.  At 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To know whether the model will be able to acheive more than 80 to 90 percentage accuracy and area under curve which would indicate a robust model with strong clinical applicability and further justifying large scale implementation  1 year 6 months 
 
Target Sample Size   Total Sample Size="323"
Sample Size from India="323" 
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)  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  

Leprosy continues to be a significant public health concern globally, with India being one of the leading contributor. The limited healthcare resources in developing countries often lead to delay in diagnosis, resulting in permanent disabilities and social marginalization. Lack of specialists and limited knowledge regarding leprosy among the primary healthcare workers contribute to a significant delay in diagnosis, revealing the existing gaps between the global leprosy elimination strategies and real world scenarios. In this regard, it is of pivotal importance that we develop alternative approaches to diagnose leprosy cases at an early stage. 

Artificial intelligence (AI) is a constantly evolving technology, which has gained significant interest recently. Deep learning is a  subset of  AI, that utilizes artificial neural networks to autonomously learn from vast amounts of data, enabling models to perform specific tasks without the  manual inputs. It has been implemented in diagnosis of different dermatological conditions including leprosy in the recent past with significant success rates. However, there is scarcity of data available regarding utility  in Indian skin. 

In 2024, World Health Organization had conducted a real-world field study of a skin-NTDs (Neglected Tropical Diseases) mobile application, which uses AI- based models to address 12 NTDs and 24 other common skin conditions .

            A similar deep learning model can be trained with feeding clinical images of varied presentations of skin lesions in leprosy and by integrating it with a mobile application, it ensures that the technology is of practical utility. The further validation of the technology by conducting a pilot study among primary health care workers would help assess its scope for real world implementation. Thus, the study aims at developing a deep learning AI model and its validation through a pilot study among primary health care workers. 

 
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