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CTRI Number  CTRI/2021/03/031787 [Registered on: 08/03/2021] Trial Registered Prospectively
Last Modified On: 08/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on cell population in psoriatic lesion 
Scientific Title of Study   A study on memory T cell population in psoriatic lesion 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sruthi Mohanan 
Designation  Post graduate resident MD DVL 
Affiliation  Amala Institute of Medical Sciences 
Address  Department of Dermatology Sacred heart block Amala Institute of Medical Sciences Amala Nagar Thrissur

Thrissur
KERALA
680555
India 
Phone  9633696172  
Fax    
Email  sruthirox15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Criton 
Designation  Head of the Department Dermatology 
Affiliation  Amala Institute of Medical Sciences 
Address  Department of Dermatology 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  Sruthi Mohanan 
Designation  Post graduate resident MD DVL 
Affiliation  Amala Institute of Medical Sciences 
Address  Department of Dermatology Amala Institute of Medical Sciences Amala Nagar Thrissur

Thrissur
KERALA
680555
India 
Phone  9633696172  
Fax    
Email  sruthirox15@gmail.com  
 
Source of Monetary or Material Support  
IADVL academy post graduate thesis grant 
 
Primary Sponsor  
Name  Amala Institute of medical Sciences 
Address  Department of Dermatology Amala Institute of Medical Sciences Amala Nagar Thrissur 
Type of Sponsor  Research institution and hospital 
 
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 
Sruthi Mohanan  Amala Institute of Medical Sciences  Department of Dermatology Amala Institute of Medical Sciences Amala Nagar Thrissur
Thrissur
KERALA 		 9633696172

sruthirox15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, 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: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with psoriasis who give consent to participate in the study, irrespective of duration of psoriasis and treatment. 
 
ExclusionCriteria 
Details  1. Patients with active fever or severe infection.
2. Patients with other skin diseases or erythroderma.
3. Patients who had undergone other modalities of treatment- Ayurveda/Unani/Siddha/Homeopathy- in the past 3 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. T cell density in lesional Vs perilesional skin.
2. Difference in density amon various treatment groups 		 All outcomesare measured at baseline since it is a cross sectional observational study 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  N/A 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/03/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sruthirox15@gmail.com].

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The study aims to observe the skin resident memory T cell (Trm) population in psoriatic patients and to correlate with response to various treatment modalities already taken. Memory cells are found in increased numbers in active psoriatic lesions, and their density decreases with treatment. Whether there is a relation of memory T cell population with psoriasis severity or same site recurrence is yet to be detected. Establishing such a causal relation will be a breakthrough, helping in targeted therapy for psoriasis. Recent studies also show that memory T cell density can act as a predictor of prolonged course of disease, hence guiding the choice of treatments. Our hypothesis is that memory T cell density is decreased on effective treatment.

 
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