| CTRI Number |
CTRI/2021/03/031817 [Registered on: 09/03/2021] 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 vitiligo to correlate the pathology findings in skin of vitiligo patients and the immune status of lesions of vitiligo skin. |
|
Scientific Title of Study
|
A DESCRIPTIVE STUDY ON CLINICAL EVALUATION OF STABILITY OF VITILIGO AND ITS CORRELATION WITH DERMOSCOPY AND HISTOPATHOLOGY WITH EMPHASIS ON CELLULAR STABILITY BY IMMUNOHISTOCHEMISTRY USING CD4 CD8 COUNTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhurya santosh |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college |
| Address |
Rajarajeshwari medical college kambipura bangalore Department of dermatology venereology and leprosy room no 1118
Rajarajeshwari medical college kambipura bangalore. Department of dermatology venereology and leprosy room no 1118
Bangalore
KARNATAKA
560074
India |
| Phone |
9900080604 |
| Fax |
|
| Email |
madhuryasantosh94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Belliappa PR |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeshwari medical college kambipura bangalore depatment of Dermatology Venereology and Leprosy room no 1118
Rajarajeshwari medical college kambipura bangalore of Dermatology Venereology and Leprosy room no 1118
Bangalore
KARNATAKA
560074
India |
| Phone |
9449664666 |
| Fax |
|
| Email |
drbelliappa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhurya santosh |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college |
| Address |
Rajarajeshwari medical college kambipura bangalore of Dermatology Venereology and Leprosy room no 1118
Rajarajeshwari medical college kambipura bangalore of Dermatology Venereology and Leprosy room no 1118
Bangalore
KARNATAKA
560074
India |
| Phone |
9900080604 |
| Fax |
|
| Email |
madhuryasantosh94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Association of Dermatologits Venereologists and Leprosy Thesis Grant. |
|
|
Primary Sponsor
|
| Name |
Indian Association Of Dermatologists Venereologists And Leprologists |
| Address |
IADVL India. |
| Type of Sponsor |
Other [Association. ] |
|
|
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 MADHURYA S |
Rajarajeswari Medical College and Hospital |
Rajarajeshwari Medical College and Hospital. kambipura bangalore . Department of Dermatology Venereology and Leprosy Room no 1118
Bangalore
KARNATAKA |
9900080604
madhuryasantosh94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age above 18 years and any sex with clinically
diagnosed cases of vitiligo. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The dermoscopic findings of lesional and
marginal skin is correlated with histoptahologcal findings and IHC
findings.
If the findings of dermoscopy , histopathology and
immunohistochemistry show consistent findings , Through this we will
be able to offer the patients with stable vitiligo earlier surgical
management at end of 6 months. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The dermoscopic findings of lesional and
marginal skin is correlated with histoptahologcal findings and IHC
findings.
If the findings of dermoscopy , histopathology and
immunohistochemistry show consistent findings , Through this we will
be able to offer the patients with stable vitiligo earlier surgical
management . |
1 year |
|
|
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)
|
11/03/2021 |
| 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="2"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To determine dermoscopy features in clinically stable and unstable vitiligo. To correlate dermoscopy with histopathology. To evaluate cellular stability of vitiligo by immunohistochemistry using CD4 AND CD8 COUNTS and correlate this with histopathology and dermoscopy. |