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CTRI Number  CTRI/2019/05/019124 [Registered on: 14/05/2019] Trial Registered Prospectively
Last Modified On: 20/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Diagnostic
Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Understanding the role of skin resident immune cells in pathogenesis of skin inflammatory disorders like psoriasis and atopic dermatisis. 
Scientific Title of Study   Role of skin resident T-cells in skin inflammatory diseases like psoriasis and atopic dermatitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chitra Nayak 
Designation  HOD of Skin and VD department 
Affiliation  Topiwala National medical college and B.Y.L Nair hospital 
Address  OPD 14, 2nd floor, OPD Building, T.N.M.C. and B.Y.L. Nair Ch Hospital. Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone    
Fax    
Email  chitra1202@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Rahul Purwar 
Designation  Associate Professor 
Affiliation  IIT Bombay 
Address  Lab 302, Dept. of Biosciences & Bioengineering, Indian Institute of Technology Bombay

Mumbai
MAHARASHTRA
400076
India 
Phone    
Fax    
Email  purwarrahul@iitb.ac.in  
 
Details of Contact Person
Public Query  
Name  Rahul Purwar 
Designation  Associate Professor 
Affiliation  IIT Bombay 
Address  Lab 302, Dept. of Biosciences & Bioengineering, Indian Institute of Technology Bombay

Mumbai
MAHARASHTRA
400076
India 
Phone    
Fax    
Email  purwarrahul@iitb.ac.in  
 
Source of Monetary or Material Support  
IIT Bombay 
 
Primary Sponsor  
Name  IIT Bombay 
Address  IIT Bombay, Powai. Mumbai Maharashtra- 400076 
Type of Sponsor  Research institution 
 
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 
Prof Rahul Purwar  IIT Bombay  Lab 302, Dept. of Biosciences & Bioengineering. Indian Institute of Technology Bombay, Powai. Mumbai 400076
Mumbai
MAHARASHTRA 		 9769407737

purwarrahul@iitb.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal appearing skin discarded after cosmetic surgery/plastic/circumcision 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, (2) ICD-10 Condition: L858||Other specified epidermal thickening,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alterations in the T cell mediated changes in the properties of keratinocytes that aids disease progression  1. Keratinocytes will be isolated from the patient samples 2. Impact of T-cell derived cytokines on the molecular and mechanical properties of keratinocytes will be monitored. 3. Mechanical properties will be indicative of the skin texture and integrity 4. Using biologics or drugs to reduce the effect of T-cell derived cytokines 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Disease activity:Early/non-severe as well as severe cases of AD and psoriasis.
Atopic dermatitis type- acute/sub-acute/ chronic
Psoriasis type- acute/chronic plaque

Normal appearing skin discarded after cosmetic
surgery/plastic/circumcision
No sign of severe infection skin, inflammation 
 
ExclusionCriteria 
Details  Skin with severe infection (patients with Hepatitis B/Hepatitis C and HIV infection) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understanding the role of skin resident T cells is central to modifying their function in the course
of treating human diseases. We expect that knowledge generated from this study
will provide the novel insight into the pathogenesis of atopic dermatitis and
psoriasis and will have a significant impact on developing better treatment for atopic dermatitis
and psoriasis. 		 3 years. 
 
Secondary Outcome  
Outcome  TimePoints 
Role of T-cell derived cytokine on the whole proteome and metabolome of keratinocytes  3 years 
 
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)   30/05/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Differential Influence of IL-9 and IL-17 on Actin Cytoskeleton Regulates the Migration Potential of Human Keratinocytes 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Skin resident T-cells are the most important T-cells with regard to immune-surveillance in the skin. The cytokines produced by these cells acts as a mediator of inflammation mounted either as a protective response or during inflammatory diseases. Th-9 is a skin resident T-cell that is the bulk producer of IL-9 in the skin. Role of IL-9 produced by the T cells in circulation is very pronounced in inflammatory diseases such as asthma and atopic
dermatitis. Another cytokine produced as a defense mechanism during pathogenic insult is IL-17, whose pathogenic role is pronounced in psoriasis when it is overproduced.

With this proposal, we aim to isolate keratinocytes from skin using a well established method in our lab. Next, the effect of IL-9, IFN-γ,IL-17A, IL-4 and IL-13 on the keratinocytes will be studied in terms of gene expression, proteomics, metabolomics and mechanical properties. Translation of the ex vivo findings into in vivo will be done with biopsies of AD and psoriasis patients. Understanding the role of T-cell derived cytokines from the skin resident population will likely shed considerable light upon pathophysiology of AD and psoriasis and designing the most appropriate treatment for the same.
 
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