| CTRI Number |
CTRI/2026/03/105470 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two oral medicines used to treat active vitiligo, a condition where white patches on the skin keep spreading. One medicine is Tofacitinib, and the other is Betamethasone given in mini-pulse doses. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF THERAPEUTIC EFFECTIVENESS OF ORAL TOFACITINIB VERSUS BETAMETHASONE ORAL-MINI PULSE THERAPY IN TREATMENT OF UNSTABLE VITILIGO PATIENT IN OPD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMYAK JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE, INDORE |
| Address |
AB Rd, CRP Line, Indore, Madhya Pradesh 452001
Mahatma Gandhi Memorial Government Medical College
Indore
MADHYA PRADESH
452001
India |
| Phone |
9039477705 |
| Fax |
|
| Email |
samyakjain1326@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritica Debnath Mathur |
| Designation |
Assistant Professor |
| Affiliation |
MGM MEDICAL COLLEGE, INDORE |
| Address |
AB Rd, CRP Line, Indore, Madhya Pradesh 452001
Mahatma Gandhi Memorial Government Medical College
MADHYA PRADESH
452001
India |
| Phone |
7974890077 |
| Fax |
|
| Email |
priticadebnath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAMYAK JAIN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE, INDORE |
| Address |
AB Rd, CRP Line, Indore, Madhya Pradesh 452001
Mahatma Gandhi Memorial Government Medical College
MADHYA PRADESH
452001
India |
| Phone |
9039477705 |
| Fax |
|
| Email |
samyakjain1326@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM MEDICAL COLLEGE INDORE |
|
|
Primary Sponsor
|
| Name |
MGM MEDICAL COLLEGE INDORE |
| Address |
Mahatma Gandhi Memorial Government Medical College,
AB Rd, CRP Line, Indore, Madhya Pradesh 452001 |
| Type of Sponsor |
Government medical college |
|
|
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 SAMYAK JAIN |
Maharaja Yeshwantrao ( M. Y) Hospital |
Room 213-18,OPD Building,Maharaja Yeshwantrao ( M. Y) Hospital,
AB Rd, CRP Line, Indore, Madhya Pradesh 452001
Indore
MADHYA PRADESH |
9039477705
samyakjain1326@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS AND SCIENTIFIC REVIEW COMMITTEE M.G.M MEDICAL COLLEGE AND M.Y HOSPITAL INDORE |
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 |
ORAL BETAMETHASONE MINI PULSE |
ORAL BETAMETHASONE MINI PULSE THERAPY GIVEN AS 5MG ON TWO CONSECUTIVE DAYS PER WEEK FOR 12 WEEKS IN PATIENTS WITH UNSTABLE VITILIGO |
| Intervention |
ORAL TOFACITINIB |
ORAL TOFACITINIB 5MG TWICE DAILY FOR 12 WEEKS IN PATIENTS WITH UNSTABLE VITILIGO |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–50 years
Clinical diagnosis of unstable vitiligo
Previously untreated patient
Consenting Patient
|
|
| ExclusionCriteria |
| Details |
Patients with stable vitiligo
History of severe infections or immunosuppression
Pregnant or lactating women
Known hypersensitivity to Tofacitinib or corticosteroids
Patients with uncontrolled diabetes, hypertension, or other serious comorbidities
Patients currently on systemic immunomodulatory therapy for other diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in VASI Score from baseline to 12 weeks
|
Baseline
4 Weeks
8 Weeks
12 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
16/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a comparative clinical study to evaluate the therapeutic effectiveness and safety of oral tofacitinib versus oral betamethasone mini pulse therapy in patients with unstable vitiligo. Vitiligo is an acquired depigmentary disorder characterized by loss of functional melanocytes leading to depigmented patches on the skin. Unstable vitiligo is defined by appearance of new lesions or increase in size of existing lesions over the last three months.
Eligible patients attending the dermatology outpatient department will be enrolled after obtaining written informed consent. Participants will be randomly allocated into two groups. One group will receive oral tofacitinib, and the other group will receive oral betamethasone mini pulse therapy for a period of three months.
Patients will be assessed at baseline and at follow up visits every four weeks for extent of disease, disease activity, and repigmentation using standard clinical assessment tools. Safety will be evaluated by monitoring adverse events and laboratory parameters.
The results of this study will help in determining a more effective and safer systemic treatment option for management of unstable vitiligo. |