| CTRI Number |
CTRI/2020/06/025516 [Registered on: 01/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of dermatoscopic features of vitiligo with the disease activity and response to treatment |
|
Scientific Title of Study
|
A study to sequentially determine the dermatoscopic features of vitiligo and its correlation with disease activity and treatment response |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay K |
| Designation |
Assistant Professor, Dermatology |
| Affiliation |
Department of Dermatology, PGIMER, Chandigarh |
| Address |
Office of Department of Dermatology, 2nd floor,
Nehru Hospital,
PGIMER,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
Vinay.keshavmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay K |
| Designation |
Assistant Professor, Dermatology |
| Affiliation |
Department of Dermatology, PGIMER, Chandigarh |
| Address |
Office of Department of Dermatology, 2nd floor,
Nehru Hospital,
PGIMER,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
Vinay.keshavmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay K |
| Designation |
Assistant Professor, Dermatology |
| Affiliation |
Department of Dermatology, PGIMER, Chandigarh |
| Address |
Office of Department of Dermatology, 2nd floor,
Nehru Hospital,
PGIMER,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
Vinay.keshavmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology |
| Address |
Office of Department of Dermatology,
2nd floor, Nehru Hospital,
PGIMER,
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vinay K |
PGIMER, Chandigarh |
Skin OPD, 5th floor, New OPD
Chandigarh
CHANDIGARH |
8872993222
vinay.keshavmurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
NIL |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical diagnosis of segmental or non segmental vitiligo
2. Patients with active disease
3. Patients initiated on medical management |
|
| ExclusionCriteria |
| Details |
1. Patients with stable disease
2. Patients who receive phototherapy or surgical management
3. Patients who did not give consent for participation in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To sequentially determine the dermatoscopic features of vitiligo |
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To correlate dermatoscopic features with disease activity assessed by means of VIDA and VASI
2. To correlate dermatoscopic features of repigmentation with treatment modality used |
24 weeks |
|
|
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)
|
01/06/2020 |
| 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="0"
Days="0" |
|
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)?
|
|
Brief Summary
|
Vitiligo has an acquired disorder of hypopigmentation. Many markers of disease activity In vitiligo has been described previously. Dermatoscopy is a non invasive tool which allows us to view structures are macroscopically invisible to the naked eye. But there has not been any longitudinal prospective study which sequentially describes the dermatoscopic markers of activity and repigmentation in active vitiligo. Therefore this observational study is being conducted to assess the dermatoscopic markers of vitiligo and to correlate the same with disease activity and treatment response. |