| CTRI Number |
CTRI/2023/01/048849 [Registered on: 10/01/2023] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Open labelled, single arm, retrospective study of oral tofacitinib in vitiligo |
|
Scientific Title of Study
|
A retrospective study to evaluate efficacy and safety of oral tofacitinib in vitiligo and its variants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-DS-003, Version 1 Dated 24 Aug 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madura C |
| Designation |
Lead Consultant Dermatosurgeon & Hair Transplantation Surgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of dermatology, Room No:10
5/1 4th Main MRCR Layout Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madura C |
| Designation |
Lead Consultant Dermatosurgeon & Hair Transplantation Surgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of dermatology, Room No:10
5/1 4th Main MRCR Layout Vijayanagar
KARNATAKA
560040
India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madura C |
| Designation |
Lead Consultant Dermatosurgeon & Hair Transplantation Surgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of dermatology, Room No:10
5/1 4th Main MRCR Layout Vijayanagar
KARNATAKA
560040
India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences
5/1 4th Main, MRCR Layout, Vijayanagar, Bangalore |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Apoorva V Bharadwaj |
CUTIS Academy of Cutaneous Sciences |
Department of dermatology, Room No:10
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA |
9686257492
veebsokplease@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS 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 |
NA |
NA |
| Intervention |
Tofacitinib Tab |
5mg Twice a daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All clinically diagnosed cases of different variants of vitiligo
2.Patients who were started on oral tofacitinib for vitiligo
|
|
| ExclusionCriteria |
| Details |
•Patients receiving other systemic immunosuppressive drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in VASI from baseline |
After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess number of patients achieving VASI 50/75/90 at the end of treatment follow-up period
2.To assess change in BSA (Body Surface Area) from baseline
3.To assess side effect profile of tofacitinib
4.To assess occurrence of new lesions during follow-up period
5.To assess time taken for halt in progression of lesions in different body sites
6.To assess time taken for start of re-pigmentation of lesions in different body sites |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2023 |
| Date of Study Completion (India) |
23/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/07/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vitiligo is a chronic autoimmune condition associated
with marked psychological distress, especially in our country owing to the
darker skin types. There is a growing need for targeted therapies in vitiligo
for its effective clearance. JAK (Janus kinase) inhibitors act by inhibiting
IFN (Interferon) gamma signalling which is the main cytokine implicated in melanocyte
destruction(1). However, data regarding ideal dosing, efficacy and long-term safety of
oral tofacitinib in the Indian population is lacking. Through our study, we
hope to bridge this gap and aid in creating a standardised protocol for the use
of oral tofacitinib in vitiligo. |