| CTRI Number |
CTRI/2024/02/062634 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Tofacitinib versus betamethasone oral mini pulse in progressive vitiligo |
|
Scientific Title of Study
|
Safety and efficacy of oral tofacitinib versus betamethasone oral mini-pulse therapy in the treatment of progressive non-segmental vitiligo: a pilot randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathvi KM |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Science, New delhi. |
| Address |
Department of Dermatology and Venereology, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7795085405 |
| Fax |
|
| Email |
sathvikm14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Dermatology and Venereology, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871213543 |
| Fax |
|
| Email |
doctor.vishalgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Dermatology and Venereology, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871213543 |
| Fax |
|
| Email |
doctor.vishalgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology and Venereology, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Ansari Nagar, New Delhi 110029 |
| 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 |
| Dr Sathvi KM |
AIIMS, New Delhi |
Department of Dermatology and Venereology,3rd floor,New Rajkumari amrit kaur OPD, AIIMS, New Delhi, India
New Delhi
DELHI |
7795085405
sathvikm14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee, AIIMS, New Delhi |
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 |
Betamethasone oral mini-pulse |
Oral betamethasone 5mg on 2 consecutive day per week for six months |
| Intervention |
Tofacitinib |
Oral tofacitinib 5mg twice daily for six months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with rapidly progressive non segmental vitiligo with more than or equal to 5 new lesions in a month or more than or equal to 15 new lesions in 3 months |
|
| ExclusionCriteria |
| Details |
1. Patients with segmental or stable or slowly progressive vitiligo
2. Pregnant or lactating females
3. Patients with known contraindictions to oral steroids or tofacitinib
4. Patients on topical treatment for last 2 weeks or systemic treatment for 4 weeks
5. Patients with latent tuberculosis infection not willing to take isoniazid preventive treatment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with disease arrest (no new lesions and no progression of pre-existing patches) at every visit as confirmed on sequential photographs |
at 4, 8, 12, 16, 20 and 24 weeks (at every visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean number of new vitiligo lesions during the study period (intra- and inter group comparison) |
at every visit |
| Mean VSAS score during the study period (intra- and inter group comparison) |
at every visit |
| Proportion of patients in different VIDA score categories (inter-group comparison) |
at every visit |
| Mean VDAS and VDIS scores during the study period (intra- and inter group comparison) |
at 3rd and 6th month visit |
| Mean VES (intra- and inter group comparison) |
at baseline, 3rd and 6th month visit |
| Mean VIS-22 scores (intra- and inter group comparison) |
at baseline, 3rd and 6th month visit |
| Proportion of patients with a change of VIS-22 score more than 5 points (inter-group comparison) |
at 6th month visit |
| Proportion of patients with different GQ responses (inter-group comparison) |
at every follow up visit |
| Comparison of side effects profile in both groups |
at every follow up visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2024 |
| 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 Yet Recruiting |
| 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
|
There is an unmet need for a non-steroidal safe and effective treatment for arresting progressive vitiligo. There are reports of tofacitinib causing re-pigmentation in vitiligo, but its effect on disease progression is not known. Aim of this study is to compare the safety and efficacy of oral tofacitinib with OMP in treating progressive vitiligo.
Research
Question
What is the safety and efficacy of oral
tofacitinib compare to betamethasone oral mini pulse in treatment of
progressive non-segmental vitiligo?
Null
hypothesis
Oral
tofacitinib is inferior to betamethasone
oral mini pulse in treating progressive vitiligo.
Alternate
hypothesis
Oral
tofacitinib is non-inferior to betamethasone oral pulse in treating progressive
vitiligo.
Aims and Objectives
1. Primary objective
To compare the efficacy
of oral tofacitinib versus betamethasone oral mini-pulse in arresting disease activity in patients
with progressive non-segmental vitiligo
2. Secondary objectives
2.1 To
compare re-pigmentation with oral tofacitinib versus betamethasone oral mini-pulse
2.2 To
compare the change in quality of life in patients receiving oral tofacitinib versus
betamethasone oral
mini-pulse
2.3 To
compare the side effects profile of oral tofacitinib versus betamethasone oral mini pulse |