| 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
|
|
|
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
|
|
|
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. |