| CTRI Number |
CTRI/2017/11/010573 [Registered on: 21/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of various HLA genes in Early on set of Psoriasis or Late on set of Psoriasis. |
|
Scientific Title of Study
|
A Study on Genetic predisposition and Skin Microbiome in Psoriasis patients attending Tertiary Care Hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Murthy C |
| Designation |
Junior Research Fellow |
| Affiliation |
Chettinad Academy of Research and Education. |
| Address |
Chettinad Academy of Reseach and Education. Chettinad Health City.Rajiv Gandhi Salai, Kelambakkam
Kanchipuram Dist.
Tamil Nadu 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9710496869 |
| Fax |
47413300 |
| Email |
krishnacare15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Murthy C |
| Designation |
Junior Research Fellow |
| Affiliation |
Chettinad Academy of Research and Education. |
| Address |
Chettinad Academy of Reseach and Education. Chettinad Health City.Rajiv Gandhi Salai, Kelambakkam
Kanchipuram Dist.
Tamil Nadu 603103
TAMIL NADU
603103
India |
| Phone |
9710496869 |
| Fax |
47413300 |
| Email |
krishnacare15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S Srinivasan |
| Designation |
HOD and Professor |
| Affiliation |
Chettinad Academy of Research and Education. |
| Address |
Chettinad Hospital and Research Institute. Chettinad Health City.Rajiv Gandhi Salai, Kelambakkam
Kanchipuram Dist.
Tamil Nadu 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9884154232 |
| Fax |
47413300 |
| Email |
hamsrini@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education- Research Fellowship. |
|
|
Primary Sponsor
|
| Name |
Chettinad Academy of Research and Education Research Fund |
| Address |
Chettinad Health City
Rajiv Gandhi Salai
Kelambakkam
Kanchipuram Dist.
Tamil Nadu 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 0 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Psoriasis., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with all types of Psoriasis along with control will be included as a source of samples to carry out this study. |
|
| ExclusionCriteria |
| Details |
Foreign patients with psoriasis will be excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of candidate genes in HLA Class II ,as predisposition factor for either Early onset of Psoriasis or Late onset of Psoriasis in Psoriasis Patients. |
Study duration is 3 years in with comparison of Early on set of Psoriasis or Late onset of Psoriasis with their mean age differences in Psoriasis patients.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skin Microbial Flora will be elucidated in Psoriasis patients with genetic predisposition. |
Duration is 3 years. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/05/2016 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis is a common inflammatory skin disorder characterised by disruption of
keratinocyte terminal and premature desquamation of stratum conium. Patho
physiology includes the activation , migration of cells to the dermis triggering
the release of cytokines (TNF α )which leads to inflammation and rapid
production of skin cells , common triggers are skin trauma, stress, systemic
infections, long term and abrupt use of drugs. Types of Psoriasis – Plaque,
Pustular , Guttate , Erythrodermic , Palmoplantar Psoriasis.
World prevalence rate is ~3%, incidence rate in USA 78.9/100,000 personyears,
Psoriasis prevalence rate in India is ~2%. Risk susceptibility loci within MHC region on
chromosome 6 called PSORS1-9 ;- accounts 35-50% for Psoriasis.
PSORS1 region on chromosome 6p21 spanning 200 kb of MHC class I region
accounts for upto 50% of the familial psoriasis predominantly HLA Cw06 ,
HLA DR 7 (Indumathi et al) , HLA DRB1 , HLA DQB1 are associated with
psoriasis and considered as psoriasis susceptible risk alleles in Human beings in
various parts of the world. HLA DRB1 phenotype is strongly associated with
PsA in type 1 Psoriasis patients . This study , aims to determine the frequency of subclinical microbial infection
and variety of microbial flora in patients suffering from psoriasis. And
highlights the other common environmental factors commonly trigger the
common inflammatory skin infection to complex disease – Psoriasis. Aim & Objectives 1. To evaluate the association of HLA-Cw6, HLA DR 7 , HLA DRB1
HLA DQB1 in Psoriasis. (all types of Psoriasis.) 2. To characterise the Bacterial , Fungal isolates of Psoriasis .
Antibiotic Susceptibility pattern will be determined , for the
culture isolates. |