| CTRI Number |
CTRI/2026/01/100845 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [Phototherapy (NB-UVB)] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Effectiveness of Tofacitinib Ointment and a Control Cream Along with Light Therapy in Vitiligo |
|
Scientific Title of Study
|
Effectiveness of topical tofacitinib 2 percent ointment versus placebo with whole-
body phototherapy in patients with non-segmental vitiligo: A split-body study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Guleri |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Office of the Department of Dermatology, Venereology and Leprology, F Block, level 2
Nehru Hospital,
Post Graduate Institute of Medical Education and Research, Madhya Marg, sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
8894279792 |
| Fax |
|
| Email |
shubhamguleri.2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Sendhil Kumaran |
| Designation |
Professor and Guide |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Office of the Department of Dermatology, Venereology and Leprology, F Block, level 2
Nehru Hospital,
Post Graduate Institute of Medical Education and Research, Madhya Marg, sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
8872004023 |
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Shubham Guleri |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Office of the Department of Dermatology, Venereology and Leprology, F Block, level 2
Nehru Hospital,
Post Graduate Institute of Medical Education and Research, Madhya Marg, sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
8894279792 |
| Fax |
|
| Email |
shubhamguleri.2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh-160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
Department of Dermatology, Venereology & Leprology, Postgraduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh 160012 |
| 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 Shubham Guleri |
Post Graduate institute of Medical Education and Research |
Office of the Department of Dermatology, Venereology and Leprology, F Block, level 2
Nehru Hospital,
Post Graduate Institute of Medical Education and Research, Madhya Marg, sector 12, Chandigarh
Chandigarh CHANDIGARH |
8894279792
shubhamguleri.2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate institute of Medical Education and Research, Chandigarh Institutional Ethics committee (Intramural) |
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 |
| Intervention |
2% tofacitinib ointment plus whole-body NB-UVB phototherapy |
In this intra-individual, non-randomized, split-body study, the right side of the body will receive topical tofacitinib 2% ointment, applied twice daily over vitiligo lesions, in combination with whole-body narrow-band ultraviolet B (NB-UVB) phototherapy administered three times weekly on alternate days. Whole body NB-UVB will be delivered through the Daavlin 3 series walk-in chamber. It emits light
at 311nm wavelength using 48 narrow-band UV lamps. Dosing will be done according to consensus guidelines by the Vitiligo working group. In both groups, NB-UVB will be administered thrice weekly on alternate days. The starting dose will be 200mJ/cm2, and it will be increased by 20% upon each visit. The maximum permissible dose for
the body in a given treatment is 3000mJ/cm2. The most tolerable dose for the patient would be when there is minimal perceptible erythema less than 24 hours. No dose increments will be done if there is asymptomatic fixed erythema at 48 hours and the phototherapy will be stopped till the
skin becomes light pink and the phototherapy will be resumed at the last tolerated dose. If symptomatic erythema occurs, phototherapy will be discontinued until the skin heals and the erythema subsides. It will be restarted at the last tolerable dose. In case of missed dosing, if the
dose is missed for 4-7 days, the same dose will be continued. The dose is decreased by 25%,50% if the therapy is not taken for 8-14 and 15-21 days respectively. If the patient missed
treatment for more than 3 weeks, the dose will be started at the initial dose. |
| Comparator Agent |
Placebo (moisturizer) plus whole-body NB-UVB phototherapy |
In this intra-individual, non-randomized, split-body study, the left side of the body will serve as the control, receiving a moisturizer cream (placebo) applied twice daily over vitiligo lesions, along with the same whole-body NB-UVB phototherapy protocol as used for the intervention side, with each patient serving as their own control. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of non-segmental vitiligo involving 5% or more body surface area with distinct lesions
over bilateral upper limbs or lower limbs or both sides of the trunk, not crossing midline.
irrespective of disease activity.
2) Size of the target patch equal to or more than 5x5 cm. |
|
| ExclusionCriteria |
| Details |
1) Patients with segmental Vitiligo.
2) History of previous phototherapy or other immunosuppressive treatment (for patients
receiving phototherapy, any systemic or local immunosuppressive therapy, a washout period
of 4 weeks is required for systemic treatments and 2 weeks for topical treatments).
3) Patients without distinct lesions over bilateral upper limbs or lower limbs or both sides of the
trunk (left and right).
4) Patients of vitiligo with <5% body surface area involvement, who are not candidates for full
body NB-UVB phototherapy.
5) Contraindications to the use of NB-UVB.
6) Intake of phototoxic drugs.
7) History of skin malignancy or any current pre-malignant condition.
8) Claustrophobia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patches achieving F-VASI 75 response at 24 weeks in both groups. |
At the end of the follow-up at 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patches achieving F-VASI 50 response at 24 weeks in both groups. |
At the end of the follow-up at 24 weeks. |
| Proportion of patches achieving vitiligo noticeability scale (VNS) 4 or 5. |
At the end of the follow-up at 24 weeks. |
| To compare the mean time taken to achieve F-VASI 50 in both groups. |
|
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/01/2026 |
| 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
|
Vitiligo is an acquired depigmentary disorder characterized by loss of melanocytes. Few studies have already shown that combination treatment is often superior as compared to monotherapy in the treatment of vitiligo. Oral and topical JAK inhibitors like tofacitinib have been found to be beneficial when used in combination with whole-body phototherapy. Combination treatment has been shown to produce a better extent of repigmentation as compared to monotherapy alone. Combination treatments are often considered superior to monotherapy. Recent studies have identified Janus kinase (JAK) inhibitors, such as oral and topical tofacitinib, as promising agents targeting the underlying immune dysregulation in vitiligo. Tofacitinib blocks JAK pathways involved in the pathogenesis of vitiligo, potentially promoting repigmentation when combined with phototherapy. However, existing clinical data on the combination therapy efficacy and safety is limited, particularly from well-controlled studies. There are a few studies showing a combination of oral JAK inhibitors with phototherapy superior to either monotherapy, and some case reports showing a combination of topical JAK inhibitors with phototherapy producing good repigmentation in patients with vitiligo. However, there are no studies that have compared the combination of topical JAK inhibitor (tofacitinib 2%) with whole body NB-UVB phototherapy to the combination of placebo with whole body NB-UVB phototherapy in patients with non-segmental vitiligo. In this study, we aim to compare the effectiveness of topical tofacitinib 2% ointment versus placebo with whole-body phototherapy in patients with non-segmental vitiligo. The findings from this study will help us to determine whether using topical tofacitinib along with phototherapy significantly improves treatment outcomes over phototherapy alone or not. By using a split-body design, this study minimizes inter-patient variability, allowing for a more precise evaluation of tofacitinib’s additive benefit in repigmentation. |