| CTRI Number |
CTRI/2025/08/092473 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of topical tacrolimus 0.1% and topical tofacitinib 2% in patients with non-segmental vitiligo |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of topical tacrolimus 0.1% vs topical tofacitinib 2% in non segmental vitiligo 2% in non-segmental vitiligo |
| 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 Itee Gaur |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy, D block, 5th floor
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9685586661 |
| Fax |
|
| Email |
gauritee1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasleen Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy, D block, 5th floor
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646481249 |
| Fax |
|
| Email |
jasleenksandhu21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasleen Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy, D block, 5th floor
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646481249 |
| Fax |
|
| Email |
jasleenksandhu21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh, India, Pin code 160030 |
|
|
Primary Sponsor
|
| Name |
Dr Itee Gaur |
| Address |
Department of Dermatology, D block, 5th floor, Government Medical College and Hospital, Sector 32, Chandigarh, India, pin code 160030 |
| 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 Itee Gaur |
Government Medical College and Hospital, Sector32, Chandigarh |
Department of Dermatology, Venereology and Leprosy, D block 5th floor, GMCH 32, Chandigarh
Chandigarh
CHANDIGARH |
9685586661
Gauritee1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH 32, Chandigarh |
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 |
Topical tacrolimus 0.1% ointment |
Topical tacrolimus 0.1% ointment twice daily for 16 weeks |
| Intervention |
Topical tofacitinib 2% ointment |
Topical tofacitinib 2% ointment twice daily for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than 5 years
2) Clinical diagnosis of non-segmental vitiligo
3)Body surface area involvement less than or equal to 10%
4) Stable vitiligo (no new lesions in last 12 weeks)
5) Willingness for a 2 week washout if on prior topical therapy |
|
| ExclusionCriteria |
| Details |
1) Segmental vitiligo
2) Pregnant or lactating women
3) Allergy to study medications
4) Recent (within 4 weeks) systemic immunosuppressants or phototherapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of repigmentation of lesions as assessed by Vitiligo Disease Improvement Score (VDIS) |
Baseline, Weeks 4, 8, 12, 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective assessment using physician global assessment scale |
Baseline, Weeks 4, 8, 12, 16 |
| Time to visible repigmentation |
Baseline, Weeks 4, 8, 12, 16 |
| Patient satisfaction (VNS Score) |
Baseline, Weeks 4, 8, 12, 16 |
| Adverse effects |
Baseline, Weeks 4, 8, 12, 16 |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/09/2025 |
| 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="6"
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 aims to compare the efficacy and safety of topical tacrolimus 0.1% and topical tofacitinib 2% in the treatment of vitiligo. Vitiligo is a common acquired depigmenting disorder with limited therapeutic options. Topical calcineurin inhibitors like tacrolimus are widely used, whereas topical Janus kinase (JAK) inhibitors like tofacitinib are emerging as promising alternatives. This is a 16 week, randomized, open label, parallel group clinical trial involving patients with stable, non segmental vitiligo. Eligible participants will be randomized to receive either topical tacrolimus 0.1% ointment or topical tofacitinib 2% cream applied twice daily. The primary endpoint will be the percentage of repigmentation assessed using the Vitiligo Disease Improvement Score(VDIS) at week 16. Safety and local tolerability will also be assessed. The study will be conducted at a tertiary care dermatology center and aims to contribute evidence regarding the comparative role of JAK inhibitors in the topical treatment of vitiligo. |