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CTRI Number  CTRI/2025/04/085220 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on cutaneous resident memory T cell population in contact dermatitis 
Scientific Title of Study   A study on cutaneous resident memory T cell population in contact dermatitis and its correlation with the type of contact dermatitis, duration, severity and recurrence of the disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Haritha Prasanth 
Designation  Junior Resident 
Affiliation  Amala Institute of Medical Sciences 
Address  Department of Dermatology, Amala Institute of Medical Sciences, Amala nagar,Thrissur
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Thrissur
KERALA
680555
India 
Phone  9496489136  
Fax    
Email  harithaprasanth254@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sebastian Criton 
Designation  Professor and HOD 
Affiliation  Amala Institute of Medical Sciences 
Address  Department of Dermatology, Amala Institute of Medical Sciences, Amala nagar,Thrissur
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Thrissur
KERALA
680555
India 
Phone  9447009990  
Fax    
Email  criton@thecriton.com  
 
Details of Contact Person
Public Query  
Name  Dr Sebastian Criton 
Designation  Professor and HOD 
Affiliation  Amala Institute of Medical Sciences 
Address  Department of Dermatology, Amala Institute of Medical Sciences, Amala nagar,Thrissur
Amala Institute of Medical Sciences, Amala nagar,Thrissur
Thrissur
KERALA
680555
India 
Phone  9447009990  
Fax    
Email  criton@thecriton.com  
 
Source of Monetary or Material Support  
ICMR financial support for the ICMR MD thesis for the 2023 batch-reg 
 
Primary Sponsor  
Name  Haritha Prasanth 
Address  Junior Resident Department of Dermatology, Amala Institute of Medical Sciences, Amala nagar,Thrissur 
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 
Haritha Prasanth  Amala Institute of Medical Sciences  Department of Dermatology, Amala Institute of Medical Sciences, Amala nagar,Thrissur
Thrissur
KERALA 		 9496489136

harithaprasanth254@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Amala Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L23||Allergic contact dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients clinically diagnosed with contact dermatitis by qualified dermatologists, who give consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Patients with other skin diseases like psoriasis, vitiligo, cutaneous lupus erythematosus, alopecia areata, fixed drug eruption, melanoma, lichen planus
2. Patients with endogenous eczema
3. Patients who had taken systemic steroids, JAK inhibitors and immunomodulators in the past one month
4. Patients on topical steroids and topical calcineurin inhibitors for past 1 month
5. Patients who had undergone other modalities of treatment – Ayurveda/Homeopathy/Unani/Siddha in the past 1 month

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
comparison of memory T cell number(density) between lesional and normal skin in patients with contact dermatitis  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
EASI score, Patch Test, comparing memory T cell number between type of contact dermatitis, duration, severity and recurrence of the disease  at the same time of sample collection 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2025 
Date of Study Completion (India) 01/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is a cross-sectional study wherein 26 consecutive patients clinically diagnosed as contact dermatitis satisfying the inclusion and exclusion criteria attending OPD of dermatology department of Amala Institute of Medical Sciences who consent for the study are selected. A detailed history will be taken and examination will be conducted. Under aseptic precaution and local anaesthesia 4mm punch biopsy will be taken from lesional and normal skin. Patients will be subjected to patch testing. The biopsy sections will be subjected to IHC staining for memory T cells using CD103 marker stain. Memory T cell population will be calculated by counting number of stained cells per 5 continuous high power field focused. Exploring more about cutaneous resident memory T cells and their role in the pathophysiology of contact dermatitis paves way for the development of various therapeutic options and thereby helping to prevent recurrences. 
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