Finding the Better Oral Treatment for Active Vitiligo: Tofacitinib vs. Mini-Pulse Steroid

Comparison Of Therapeutic Efficacy of Oral Tofacitinib And Oral Mini Pulse Steroid In Non-segmental Active Vitiligo: An Assessor Blinded Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088122

Enrollment

Registered

2025-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: Tab Tofacitinib: Tab Tofacitinib 5mg twice daily orally for 24 weeks Control Intervention1: Oral mini pulse steroid: Tab Dexamethasone 0.1mg/kg (maximum upto 5 mg) single dose after bre

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-65 years diagnosed with non-segmental active vitiligo (NSV). 2. Patient with active vitiligo, defined as vitiligo disease activity score (VIDA) of +4. 3. No systemic immunosuppressive treatments within 4 weeks before screening.

Exclusion criteria

Exclusion criteria: 1. Segmental vitiligo. 2. Any other active dermatological disorders that may interfere with the evaluation of vitiligo or its treatment (e.g., psoriasis, eczema). 3. Known allergy or hypersensitivity to tofacitinib or oral mini pulse therapy components. 4. History of other autoimmune diseases (e.g., rheumatoid arthritis, lupus) that could interfere with study results. 5. Any major infection, moderate or severe renal or hepatic impairment. 6. Pregnant or lactating women or immune - compromised patients or patients with bleeding or coagulation disorders.7. Patient having uncontrolled hypertension. 8. Hb less than 9g/dl , TLC less than 3.0 109/L, Platelet count less than 100 109/L. 9. History of malignancy except sufficiently treated non-metastatic basal cell carcinoma and squamous cell cancer of the skin or cervical carcinoma in situ.

Design outcomes

Primary

Measure	Time frame
Percentage of patients achieving arrest of disease progression (ADP) at 16 weeks and at 24 weeks.Timepoint: 16 weeks and 24 weeks	—

Secondary

Measure	Time frame
Mean time taken to achieve arrest of disease progression (ADP) at 16 weeks and at 24 weeks.Timepoint: 16 weeks and 24 weeks;Percentage reduction in VASI score in both groups at 16 weeks and 24 weeks.Timepoint: 16 weeks and 24 weeks;Assessment of disease activity by VIDA score and VDAS score in both groups at 16 weeks and 24 weeks.Timepoint: 16 weeks and 24 weeks;Assess side effects of tofacitinib and oral mini pulse steroidTimepoint: NA;Correlation of serum CXCL10 levels with disease activity and severity.Timepoint: NA;Assessment of change in serum CXCL10 levels in both groups at 24 weeks.Timepoint: 24 weeks	—

Measure

Time frame

Mean time taken to achieve arrest of disease progression (ADP) at 16 weeks and at 24 weeks.Timepoint: 16 weeks and 24 weeks;Percentage reduction in VASI score in both groups at 16 weeks and 24 weeks.Timepoint: 16 weeks and 24 weeks;Assessment of disease activity by VIDA score and VDAS score in both groups at 16 weeks and 24 weeks.Timepoint: 16 weeks and 24 weeks;Assess side effects of tofacitinib and oral mini pulse steroidTimepoint: NA;Correlation of serum CXCL10 levels with disease activity and severity.Timepoint: NA;Assessment of change in serum CXCL10 levels in both groups at 24 weeks.Timepoint: 24 weeks

—

Countries

India

Contacts

Public ContactDr Vishal Thakur

All India Institute of Medical sciences, Bathinda

drshivani.derm@gmail.com8287020404

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026