| CTRI Number |
CTRI/2024/10/075884 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Patch Test ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Using artificial intelligence application to read patch test readings in allergic contact dermatitis patients
|
|
Scientific Title of Study
|
An Inter-comparative Three Arm Study Of Patch Test Readings In Allergic Contact Dermatitis By In Person International Contact Dermatitis Research Group , Three Part Scoring System By Digital Images And Artificial Intelligence Application
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Alok |
| Designation |
Post Graduate |
| Affiliation |
JSS Academay of hugher education and research |
| Address |
Door No 1079, 1st cross , range road , G and H Block , Kuvempunagar , Mysuru 570023
JSS Medical Institutions Campus
Sri Shivarathreeshwara Nagara
Mysuru – 570 015
Karnataka
INDIA
Mysore
KARNATAKA
570023
India |
| Phone |
7337697829 |
| Fax |
|
| Email |
drvalok17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanthrag G R |
| Designation |
Professor and head of department of dermatology |
| Affiliation |
JSS Academay of hugher education and research |
| Address |
JSS Academay of hugher education and research
JSS Medical Institutions Campus
Sri Shivarathreeshwara Nagara
Mysuru – 570 015
Karnataka
INDIA
Mysore
KARNATAKA
570023
India |
| Phone |
7337697829 |
| Fax |
|
| Email |
kanthacad@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
V Alok |
| Designation |
Post Graduate |
| Affiliation |
JSS Academay of hugher education and research |
| Address |
Door No 1079,
1st cross , gange road ,
G and H Block ,
Kuvempunagar ,
Mysuru Karnataka 570023
Mysore
KARNATAKA
570023
India |
| Phone |
7337697829 |
| Fax |
|
| Email |
drvalok17@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Academy of higher education and research
JSS Medical Institutions Campus
Sri Shivarathreeshwara Nagara
Mysuru – 570 015
Karnataka
INDIA |
|
|
Primary Sponsor
|
| Name |
V Alok |
| Address |
Door no 1079, 1st Cross , range road , g and h block , Kuvempunagar ,Mysuru 570023 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS academy of higher education and research |
JSS AHER , Sri shivarathreeshwara nagar , bannimantap, Karnataka 570004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Alok |
JSS Hospital |
JSS Hospital , MG road , fort mohalla , 570004
department of dermatology , 1st floor , room no 1012
Mysore
KARNATAKA |
7337697829
drvalok17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS academy of higher education & research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patch test ICDRG criteria |
ICDRG criteria |
| Comparator Agent |
Patch test TPSS grading |
TPSS grading |
| Comparator Agent |
Patch test TPSS via Artificial intelligence application |
TPSS via Artificial intelligence application |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Clinically selected cases of allergic contact dermatitis irrespective of age and sex.
Patients willing to undergo patch test and have given informed consent .
All patients completing at least a minimum of 2 follow ups visits will be included in
the study |
|
| ExclusionCriteria |
| Details |
Patients not willing for the study .
Patients who are not willing for follow up.
Patients on immunosuppressive therapy .
Females who are pregnant and lactating .
Patients with systemic allergies such as asthma .
Patients with active contact dermatitis lesions.
Patients with dermatological diseases that is dermatitis at the site of patch test
application |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Artificial intelligence may interpret the patch test results more accurately then TPSS and ICDRG criteria |
6 months - sample collection from JSS OPD with ICDRG criteria
3 months - TPSS grading
4 months - development of Artificial intelligence based software
5 months - analysis of results and improvement in accuracy of application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Artificial intelligence application may help more patients compliance to patch test & less number of follow ups |
6 months - sample collection from JSS OPD with ICDRG criteria
3 months - TPSS grading
4 months - development of Artificial intelligence based software
5 months - analysis of results & improvement in accuracy of application |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/11/2024 |
| 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="6"
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
|
The International Contact Dermatitis Research Group (ICDRG) grading system is a gold standard method used to interpret patch test results in allergic contact dermatitis patients. However, this system requires inspection and palpation, which can be challenging with photography. The Three Part Scoring System (TPSS) was developed as an alternative tool to analyze two-dimensional images. A comparative study showed a sensitivity of 100% and specificity of 93.4% between the ICDRG criteria gold standard and TPSS digital images. The study aims to compare the ICDRG criteria in person, TPSS by digital images, and artificial intelligence using a curated application. This will simplify teledermatology practice, improve accuracy, reduce total visits needed for readings, save patients money and time, and allow them to receive medical care from home. This could help dermatologists conduct more patch tests to identify causative allergens in allergic contact dermatitis patients, potentially reducing follow-up visits and patient care delays. It may also improve patient compliance towards allergen patch testing and patient-friendly procedures. |