| CTRI Number |
CTRI/2024/01/061435 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to evaluate the disease activity in Non-segmental vitiligo. |
|
Scientific Title of Study
|
The presence of NLRP1 inflammosome immuno-staining and its correlation with disease activity in Non-segmental vitiligo. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Ashokan |
| Designation |
Post Graduate Dermatology |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences Ponekkara Road P.O Edappally
Kochi, Ernakulam, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
07353389888 |
| Fax |
|
| Email |
ashwiniashokan97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Jagadeesan |
| Designation |
Additional professor , Dermatology |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences Ponekkara Road P.O Edappally
Kochi, Ernakulam, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
09447130395 |
| Fax |
|
| Email |
soumyavivek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Ashokan |
| Designation |
Post Graduate Dermatology |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences Ponekkara Road P.O Edappally
Kochi, Ernakulam, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
07353389888 |
| Fax |
|
| Email |
ashwiniashokan97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences, Kochi |
| Indian Association of Dermatologist, Venereologists and Leprologists |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini Ashokan |
| Address |
Amrita Institute of Medical Sciences Ponekkara Road P.O Edappally
Kochi, Ernakulam, Kerala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Association of Dermatologist Venereologists and Leprologists |
IADVL Kerala branch 14th floor, IMA House
Kochi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwini Ashokan |
Amrita Institute of Medical Sciences |
Department of Dermatology , B block , Ground floor .
Ponekkara Road P.O
Edappally, Kochi
Ernakulam
KERALA |
07353389888
ashwiniashokan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting to the dermatology OPD with generalized/non-segmental vitiligo . |
|
| ExclusionCriteria |
| Details |
1) Segmental vitiligo
2) Non-segmental vitiligo patients who received any topical or systemic therapy in past 3 months duration.
3) <18 years of age
4) Associated autoimmune diseases
5) Pregnant or lactating mothers
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The presence of NLRP1 immunostaining in Non-segmental vitiligo and correlate the NLRP1 immuno-staining intensity with clinical activity in Non-segmental vitiligo using VETF scoring system
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the histopathological features of Non-segmental vitiligo using Vitiligo Histopathological scoring system proposed by Yadav et al with clinical activity / stability us-ing VETF scoring system. |
18 months |
|
|
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)
|
14/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The objectives of this study ie immunostaining of NLRP-1 and histopathological grading especially in the perilesional skin would be able to add significant information to the already available clinically scoring system , to obtain the progression / stability of the disease and maybe useful in making clinical decisions in guiding further therapeutic interventions such as performing vitiligo surgery. The study will be conducted at Amrita Institute of Medical sciences , Kochi. The study participants are the Vitiligo patients presenting to the Dermatology OPD . Only patients who are willing to be included in the study , co-operative to the need of detailed clinical and histopathological examination shall be enrolled for the study . Detailed history taking and clinical examination (based on VETF scoring index ) would be conducted and subsequent classification under as either stable or un-stable vitiligo groups .The patients would be subjected to biopsy procedure, where 2 biopsy samples ie. lesional & peri-lesional would be collected using the 4mm dermal biopsy punch .The sample would be sent for histopathological examination and subsequent Immunohistochemistry staining using Anti-NLRP1 anti-body immunostain. Direct evaluation and grading of the histopathological scoring using Vitiligo Histological scoring system by Yadav et al and presence & intensity of staining Anti-NLRP1 antibody immunostaining will be done for each patient . |