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CTRI Number  CTRI/2025/01/078963 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Effectiveness of an AI Based Mobile App for Better Management of Atopic Dermatitis 
Scientific Title of Study   Evaluating the Effectiveness of an AI Enhanced Mobile Application in Improving Management Outcomes for Atopic Dermatitis Patients A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neena Khanna 
Designation  Professor and head 
Affiliation  Amrita Hospital 
Address  Room No. 6088, LG Floor, Dermatology, Amrita Hospital, Sector 88, Faridabad, Haryana 121002

Faridabad
HARYANA
121002
India 
Phone  919312432689  
Fax    
Email  neena_aiims@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Neena Khanna 
Designation  Professor and head 
Affiliation  Amrita Hospital 
Address  Room No. 6088, LG Floor, Dermatology, Amrita Hospital, Sector 88, Faridabad, Haryana 121002

Faridabad
HARYANA
121002
India 
Phone  919312432689  
Fax    
Email  neena_aiims@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Neena Khanna 
Designation  Professor and head 
Affiliation  Amrita Hospital 
Address  Room No. 6088, LG Floor, Dermatology, Amrita Hospital, Sector 88, Faridabad, Haryana 121002

Faridabad
HARYANA
121002
India 
Phone  919312432689  
Fax    
Email  neena_aiims@yahoo.co.in  
 
Source of Monetary or Material Support  
IADVL IADVL National Headquarters: 314-315, 3rd Floor, KM Trade Tower H 3, Sector 14, Kaushambi Ghaziabad, Uttar Pradesh, India Pincode: 201010 
 
Primary Sponsor  
Name  IADVL 
Address  3rd Floor KM Trade Tower, H 3, Sector 14, Kaushambi, Ghaziabad,Uttar Pradesh. 201010 
Type of Sponsor  Other [national association of dermatologist] 
 
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 NEENA KHANNA  Amrita Hospital  Dept of Dermatology, LG floor, room no. 6085 sector 88 faridabad
Faridabad
HARYANA 		 9312432689

neena_aiims@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Amrita Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AI-enabled mobile application to manage Atopic Dermatitis   AI-enabled mobile application will be used in addition to standard treatment to manage Atopic Dermatitis. The app will include treatment reminders and chatbot for infomartion regarding diseases and general care for 12 weeks  
Comparator Agent  Standard therapy alone  Standard therapy alone for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed with atopic dermatitis by a dermatologist.
Ages 18 and above.
Smartphone users willing to use the app.
 
 
ExclusionCriteria 
Details  Patients with other primary skin disorders.
Patients with severe atopic dermatitis requiring systemic therapy.
Current participation in another clinical trial.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in SCORAD (Scoring Atopic Dermatitis) index from baseline to 12 weeks.  Change in SCORAD (Scoring Atopic Dermatitis) index from baseline to 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
changes in POEM scores, changes in DLQI scores, and patient satisfaction with the AI-enabled application at 12 weeks.  12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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  

This research project evaluates the effectiveness of an AI-powered mobile app designed to manage atopic dermatitis over two years. We aim to test whether this app can enhance treatment adherence and patient outcomes compared to traditional care methods. Initially, the project will focus on developing the app, which will include features to monitor disease severity, provide medication reminders, and offer educational support through an integrated chatbot.

Following development, the project will conduct a 15-month randomized controlled trial involving 100 patients. The effectiveness of the app will be assessed using the SCORAD index to measure changes in disease severity, alongside evaluations of treatment adherence, quality of life improvements, and patient satisfaction. The study aims to demonstrate that digital tools can significantly improve the management and outcomes of chronic dermatological conditions.

 
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