| CTRI Number |
CTRI/2018/03/012552 [Registered on: 13/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of genetic profile and its relation with disease severity in psoriasis patients. |
|
Scientific Title of Study
|
A study of miRNA223 expression and its correlation with disease severity in chronic plaque psoriasis patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bantwal Priya Baliga |
| Designation |
Postgraduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department Of Dermatology
K S Hegde Medical Academy
Nitte University
Deralakatte
Mangaluru 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9739217885 |
| Fax |
|
| Email |
priya.hi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tonita M Noronha |
| Designation |
MD DVL Associate Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department Of Dermatology
K S Hegde Medical Academy
Nitte University
Deralakatte
Mangaluru 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9538986093 |
| Fax |
|
| Email |
tones1980@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bantwal Priya Baliga |
| Designation |
Postgraduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department Of Dermatology
K S Hegde Medical Academy
Nitte University
Deralakatte
Mangaluru 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9739217885 |
| Fax |
|
| Email |
priya.hi@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy
Nitte University
Deralakatte
Mangaluru 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Bantwal Priya Baliga |
| Address |
K S Hegde Medical Academy
Dept Of Dermatology
Deralakatte mangalore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bantwal Priya Baliga |
K S Hegde Medical Academy |
Department Of Dermatology
K S Hegde Medical Academy
Nitte University
Deralakatte
Mangaluru 575018
Dakshina Kannada
KARNATAKA |
08242204471
priya.hi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with chronic plaque psoriasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
CASES
1.Patients consenting to participate in the study.
2.All chronic plaque psoriasis adult patients above 18 years of age of either gender
3.All chronic plaque psoriasis patients diagnosed clinically or following biopsy will be included.
4. All chronic plaque psoriasis patients not treated with systemic immunosuppressant in the previous 3
months.
5. All chronic plaque psoriasis patient not treated with topical immunosuppressant in the previous 2
weeks.
CONTROLS
1.Age and sex matched individuals without chronic plaque psoriasis. |
|
| ExclusionCriteria |
| Details |
CASES AND CONTROLS
1.Patients not consenting to participate in the study.
2.Patients with known autoimmune disease, malignancy, or serious chronic systemic disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased expression of miRNA223 in patients with chronic plaque psoriasis |
Expression of miRNA223 will be assessed within a period of 18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The expression of miRNA223 can increase with the increase in severity of psoriasis. |
estimation of miRNA223 will be done after collection of all cases 18 months from the time of start of study |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/12/2017 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 chronic inflammatory disease of the skin which affects the skin or joints or both in adults, with an overall prevalence being 2 to 3% of the population worldwide. This condition has substantial negative impact on the quality of life of the patients. 1.Clinically it is characterized by well-demarcated, erythematous plaques with silvery white scales. 2.MicroRNA(miRNA) are short, single-stranded, noncoding RNA molecules about 22 to 25 nucleotides in length that are capable of negatively modulating the gene expression by binding to the 3’ untranslated region (UTR) of target messenger RNAs (mRNAs), leading to their degradation or translational repression based on the degree of complementarity. 3.Various studies have shown the role of miRNAs in the pathogenesis of psoriasis. Usually miR203,miR21 and miR146a are upregulated , whereas miR125b is down regulated in psoriatic skin compared with that of healthy skin. 4.In peripheral blood mononuclear cells (PBMCs) from patients with psoriasis as compared with healthy controls, miR-193b, miR-223 and miR-143 were found to be significantly upregulated. 5.Many research studies have been conducted to identify soluble biomarkers for psoriasis, but still there is no specific biomarker that can accurately predict the progression of disease and therapeutic response.
AIMS AND OBJECTIVES OF THE STUDY 1.To determine the expression of miRNA223 in cases of chronic plaque psoriasis. 2. To compare the expression of miRNA223 in cases and controls. 3.To correlate the expression of miRNA223 with severity of chronic plaque psoriasis. |