| CTRI Number |
CTRI/2025/09/095231 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Repigmentation achieved in pediatric vitiligo patients with 2% tofacitinib ointment and 0.1% tacrolimus ointment |
|
Scientific Title of Study
|
Efficacy of 2% tofacitinib ointment against 0.1% tacrolimus ointment in localized pediatric 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 |
KUSHAL BRAR |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
lady hardinge medical college, delhi, india |
| Address |
Department of dermatology, Lady hardinge medical college, Delhi
Department of dermatology, Lady hardinge medical college, Delhi
Central
DELHI
110001
India |
| Phone |
8769622464 |
| Fax |
|
| Email |
brarkushal25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vibhu Mendiratta |
| Designation |
Head of department, Department of dermatology |
| Affiliation |
lady hardinge medical college, delhi, india |
| Address |
Head of department, department of dermatology, lady hardinge medical college, Delhi
Central
DELHI
110001
India |
| Phone |
9871016304 |
| Fax |
|
| Email |
vibhumendiratta@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KUSHAL BRAR |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
lady hardinge medical college, delhi, india |
| Address |
department of dermatology, lady hardinge medical college, delhi
Central
DELHI
110001
India |
| Phone |
8769622464 |
| Fax |
|
| Email |
brarkushal25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vibhu Mendiratta |
| Address |
Director professor and HOD, Department of dermatology, Lady hardinge medical college, New Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrKushal Brar |
Kalawati saran hospital |
room- 207, department of dermatology, lady hardinge medical college, delhi
Central
DELHI |
8769622464
brarkushal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Lady hardinge medical college |
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 |
0.1% tacrolimus ointment |
0.1% tacrolimus ointment local application twice daily for 16 weeks |
| Intervention |
2% tofacitinib ointment |
2% tofacitinib ointment local application twice daily for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients with active localized vitiligo. Body surface area of lesions less than 10 precent |
|
| ExclusionCriteria |
| Details |
acrofacial, mucosal, genital, vitiligo universalis. History of any topical or systemic medication in last three months. Child with rapidly progressing vitiligo which requires systemic treatment within 12 weeks of initiating topical therapy. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean area repigmentation in group A tofacitinib ointment and group B tacrolimus ointment at 16 weeks from baseline. |
Mean area repigmentation in group A tofacitinib ointment and group B tacrolimus ointment at 16 weeks from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| proportion of patients experiencing cutaneous side effects in both groups |
baseline, 4 weeks, 8 weeks, 12 weeks & 16 weeks |
| proportions of patients having systemic comorbidities |
baseline |
| proportion of patients in each group , aged between 10-18 years, having improvement in quality of life, according to CDLQI |
baseline & 16 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="1"
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
|
This randomized controlled trial aims to compare the efficacy and safety of 2% tofacitinib ointment with 0.1% tacrolimus ointment in children aged 6–18 years with localized vitiligo. Eligible patients, after informed consent, will be randomized into two groups: Group A will apply 2% tofacitinib ointment twice daily for 16 weeks, and Group B will apply 0.1% tacrolimus ointment twice daily for the same duration. Lesion size will be measured at baseline and at 4-weekly intervals using a transparent sheet and graph paper method, with repigmentation graded on a 0–4 scale. Serial standardized photographs and quality of life assessment using the CDLQI (for ages 10–18 years) will provide additional evaluation. Patients will be monitored for cutaneous side effects such as burning, itching, irritation, or folliculitis, and treatment will be reassessed if significant adverse events occur. The primary outcome will be the mean percentage area of repigmentation at 16 weeks, while secondary outcomes include frequency of side effects, presence of systemic comorbidities, and improvement in quality of life. Final assessment will be done at 16 weeks, and data will be analyzed statistically. |