| CTRI Number |
CTRI/2024/11/077078 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of oral methylprednisolone mini-pulse with oral tofacitinib and oral methylprednisolone mini-pulse with oral azathioprine in treatment of progressive non- segmental vitiligo |
|
Scientific Title of Study
|
Comparison of the efficacy and safety of oral methylprednisolone mini-pulse with oral tofacitinib and oral methylprednisolone mini-pulse with oral azathioprine in treatment of progressive non- segmental vitiligo: A Randomized Controlled 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 |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annu Saini |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8006167519 |
| Fax |
|
| Email |
sainiannu481998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences BHU |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
| 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 Satyendra Kumar Singh |
Sir Sunderlal Hospital BHU |
Sir Sunderlal Hospital
Department of Dermatology OPD number 207 Banaras Hindu University
Varanasi
UTTAR PRADESH |
9198120582
drsatyendraderma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BANARAS HINDU UNIVERSITY |
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 |
methylprednisolone and azathioprine |
oral methylprednisolone 32 mg on two consecutive days every week and oral azathioprine 50 mg twice daily for 6 months |
| Intervention |
methylprednisolone and tofacitinib |
oral methylprednisolone 32 mg on two consecutive days every week and oral tofacitinib 5 mg twice daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of progressive non-segmental vitiligo with affected body surface area equals to or more than 5% 2.Age: 18 to 65 years 3. Patients not taking systemic drug in last 1 month and topical treatment in last 15 days 4. All participants who give consent for the study |
|
| ExclusionCriteria |
| Details |
1. Patients having history or active tuberculosis.
2. Patients with pregnancy and lactating mother.
3. Patients with uncontrolled renal, hepatic, hematological or heart disease.
|
|
|
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 Vitiligo Area Severity Index (VASI) by 75% |
Reduction in Vitiligo Area Severity Index (VASI) by 75% which will be assessed monthly for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Vitiligo Area Severity Index (VASI) by 50% and reduction in Vitiligo Area Severity Index (VASI) by 100% |
Reduction in Vitiligo Area Severity Index (VASI) by 50% and reduction in Vitiligo Area Severity Index (VASI) by 100% which will be assessed monthly for 6 months |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
All patients aged 18 to 65 years diagnosed clinically with progressive non-segmental vitiligo coming to Dermatology OPD, SSH, BHU those who fulfill the inclusion criteria will be included in the study. All patients will be randomized equally in two groups. Group A will be given oral methylprednisolone 32 mg on two consecutive days every week and oral tofacitinib 5 mg twice daily with supportive treatment (calcium and vitamin D) for 6 months. Group B will be given oral methylprednisolone 32 mg on two consecutive days every week and oral azathioprine 50 mg twice daily with supportive treatment (calcium and vitamin D) for 6 months. All patients will be followed every month for 6 months and response evaluation will be done by Vitiligo Area Severity Index (VASI). Endpoint of treatment will be complete repigmentation or 6 months of treatment whichever achieved first.
|